Archived Policies - Surgery
Autografts and Allografts in the Treatment of Focal Articular Cartilage Lesions
Osteochondral allografting may be considered medically necessary as a technique to repair full-thickness chondral defects of the knee caused by acute or repetitive trauma when other cartilage repair techniques (e.g., microfracture, osteochondral autografting or autologous chondrocyte implantation) would be inadequate due to the size, location, or depth of the lesion.
Osteochondral autografting, using 1 or more cores of osteochondral tissue, may be considered medically necessary for the treatment of symptomatic full-thickness cartilage defects of the knee caused by acute or repetitive trauma in patients who have had an inadequate response to a prior surgical procedure, when ALL of the following criteria have been met:
Normal appearing cartilage
Swelling and Softening or Articular Cartilage
Fissuring within softened areas
Destruction of articular cartilage and exposed bone
DOCUMENTATION Required for Review of Injury and Prior Treatment/Therapies:
• Progress report, history, and/or operative notes confirming injury and prior treatments/therapies; AND
• Report(s) of standing x-rays documenting normal alignment and stability of the knee and the absence of inflammatory arthritis (e.g., rheumatoid arthritis); AND
• Report(s) from knee arthroscopy showing the presence of the cartilage defect and normal cartilage surrounding the defect.
NOTE 1: Osteochondral autografts or allografts may be performed for treatment of focal articular cartilage lesions in combination (either concurrently or sequentially) with meniscal allografts. For criteria to determine medical necessity of other concurrent or sequential procedures, please refer to the following medical policy, SUR705.034, Meniscal Allografts and Other Meniscal Implants.
NOTE 2: Additional procedures, such as repair of ligaments or tendons of an osteotomy for realignment (includes misalignment and instability) may be performed at the same time of the osteochondral autografting or allografting procedure.
Treatment of focal articular cartilage lesions with autologous and/or allogeneic minced cartilage is considered experimental, investigational and/or unproven.
Osteochondral autografting or allografting for joints other than the knee is considered experimental, investigational and/or unproven, including but not limited to the patellar (knee cap) and talar (ankle).
Osteochondral autografting or allografting is considered experimental, investigational and/or unproven when the patient selection criteria cited above are not met.
Chondral and osteochondral grafts are used in repair of full-thickness chondral defects involving the joint. In the case of osteochondral autografts, 1 or more small osteochondral plugs are harvested from non-weight-bearing sites in the knee and press fit into a prepared site in the lesion. Osteochondral allografts are typically used for larger lesions. Autologous or allogeneic minced cartilage is also being evaluated as a treatment of articular cartilage lesions.
Focal chondral defects of the knee, either due to trauma or other conditions such as osteochondritis dissecans (OCD), often fail to heal on their own and may be associated with pain, loss of function, disability, and the long-term complication of osteoarthritis. The ideal resurfacing technique would eliminate symptoms, restore normal biomechanics of the knee joint, and prevent the long-term emergence of osteoarthritis and the necessity for total knee arthroplasty (TKA). Various methods of cartilage resurfacing have been investigated including marrow-stimulation techniques such as subchondral drilling, microfracture, and abrasion arthroplasty, all of which are considered standard therapies and all of which attempt to restore the articular surface by inducing the growth of fibrocartilage into the chondral defect. However, fibrocartilage does not share the same biomechanical properties as hyaline cartilage, and thus various strategies for chondral resurfacing with hyaline cartilage have been investigated.
Both fresh and cryopreserved allogeneic osteochondral grafts have been used with some success, although cryopreservation decreases the viability of cartilage cells, and fresh allografts may be difficult to obtain and create concerns regarding infectious diseases. As a result, autologous (one's own tissue from one location to another) osteochondral grafts have been investigated as an option to increase the survival rate of the grafted cartilage and to eliminate the risk of disease transmission. Autologous grafts are limited by the small number of donor sites; thus allografts are typically used for larger lesions. In an effort to extend the amount of the available donor tissue, investigators have used multiple, small osteochondral cores harvested from non-weight-bearing sites in the knee for treatment of full-thickness chondral defects. Several systems are available for performing this procedure, the Mosaicplasty System™ (Smith and Nephew), the Osteochondral Autograft Transfer System® (OATS®; Arthrex Inc.), and the COR™ and COR2™ Systems (DePuy Mitek). Although mosaicplasty and OATS® may use different instrumentation, the underlying principle is similar (i.e., use of multiple osteochondral cores harvested from a non-weight-bearing region of the femoral condyle and autografted into the chondral defect). These terms have been used interchangeably to describe the procedure.
Preparation of the chondral lesion involves débridement and preparation of recipient tunnels. Multiple individual osteochondral cores are harvested from the donor site, typically from a peripheral non-weight- bearing area of the femoral condyle. Donor plugs range from 6 to 10 mm in diameter. The grafts are press fit into the lesion in a mosaic-like fashion into the same-sized tunnels. The resultant surface consists of transplanted hyaline articular cartilage and fibrocartilage, which is thought to provide “grouting” between the individual autografts. Mosaicplasty may be performed with either an open approach or arthroscopically. Osteochondral autografting has also been investigated as a treatment of unstable OCD lesions using multiple dowel grafts to secure the fragment. While osteochondral autografting is primarily performed on the femoral condyles of the knee, osteochondral grafts have also been used to repair chondral defects of the patella, tibia, and ankle. With osteochondral autografting, the harvesting and transplantation can be performed during the same surgical procedure. Technical limitations of osteochondral autografting are difficulty in restoring concave or convex articular surfaces, incongruity of articular surfaces that can alter joint contact pressures, short-term fixation strength and load-bearing capacity, donor site morbidity, and lack of peripheral integration with peripheral chondrocyte death associated with graft harvesting and insertion.
Recently, a minimally processed osteochondral allograft (Chondrofix®; Zimmer) has become available for use. Chondrofix® is composed of decellularized hyaline cartilage and cancellous bone and can be used “off the shelf” with precut cylinders (7-15 mm). Multiple cylinders may be used to fill a larger defect in a manner similar to OATS or mosaicplasty.
Autologous chondrocyte implantation (ACI) is another method of cartilage repair involving the harvesting of normal chondrocytes from normal non-weight-bearing articular surfaces, which are then cultured and expanded in vitro and implanted back into the chondral defect. ACI techniques are discussed in Medical Policy SUR705.035.
Filling defects with minced articular cartilage (autologous or allogeneic), is another single-stage procedure that is being investigated for cartilage repair. The Cartilage Autograft Implantation System (CAIS; Johnson and Johnson; phase 3 trial) harvests cartilage and disperses chondrocytes on a scaffold in a single-stage treatment. BioCartilage® (Arthrex) consists of a micronized allogeneic cartilage matrix that is intended to provide a scaffold for microfracture. DeNovo NT Graft (Natural Tissue Graft) is produced by ISTO Technologies with exclusive distribution rights by Zimmer. DeNovo NT consists of manually minced cartilage tissue pieces obtained from juvenile allograft donor joints. The tissue fragments are mixed intraoperatively with fibrin glue before implantation in the prepared lesion. It is thought that mincing the tissue helps both with cell migration from the extracellular matrix and with fixation. As there is no use of chemicals and minimal manipulation, the allograft tissue does not require U.S. Food and Drug Administration (FDA) approval for marketing. DeNovo® ET Live Chondral Engineered Tissue Graft (Neocartilage) is marketed by ISTO Technologies outside of the United States. DeNovo® ET graft uses juvenile allogeneic cartilage cells engineered by ISTO Technologies. The FDA approved ISTO’s Investigational New Drug application for Neocartilage in 2006, which allowed them to pursue phase 3 clinical trials of the product in humans.
This medical policy was created in 2001 and updated periodically with searches of the MedLine database. The most recent literature review was performed through July 18, 2016. The following is a summary of the key references to date.
A 2008 systematic review by Magnussen et al. assessed whether “advanced” cartilage repair techniques (osteochondral transplantation or autologous chondrocyte transplantation) showed superior outcomes in comparison with traditional abrasive techniques for the treatment of isolated articular cartilage defects. (1) Finding a total of 5 randomized controlled trials (RCTs) and 1 prospective comparative trial that met their selection criteria, Magnussen et al. concluded that no single technique had been shown to produce superior clinical results for treatment of articular cartilage defects. They stated that, “any differences in outcome based on the formation of articular rather than fibrocartilage in the defect may be quite subtle and only reveal themselves after many years of follow-up. Similarly, complications such as donor site morbidity in OAT [osteochondral autograft transfer] may be late in their presentation and thus not be detected at short follow-up.”
Harris et al. published a systematic review of combined meniscal allograft transplantation and cartilage repair/restoration in 2010. (2) Six level IV studies (case series) with a total of 110 patients were included in the review. Patients underwent meniscal allograft transplantation with either autologous chondrocyte implantation (ACI; n=73), osteochondral allograft (n=20), osteochondral autograft (n=17), or microfracture (n=3). All studies showed improvement in clinical outcomes at final follow-up compared with the preoperative condition. Outcomes were also compared with historical outcomes of each individual procedure performed in isolation. Four of the 6 studies found outcomes equivalent to procedures performed in isolation, while 2 studies found that outcomes with combined surgery were not as good as the historical controls. Across the 6 studies, 13 failures (12%) were reported; these included 11 isolated meniscal allograft transplantation failures, 1 combined meniscal allograft and ACI failure, and 1 isolated ACI failure. Three knees with failed meniscal allograft transplantation were converted to total knee arthroplasty. Nearly 50% of the patients underwent 1 or more subsequent surgeries after combined meniscal allograft transplantation and cartilage repair/restoration procedures.
Hangody, who first reported use of the mosaicplasty technique in humans in 1992, has authored a number of summaries and case series. (3-5) It is likely that these reports contain overlapping populations of patients, and few details are reported. In a 1997 article, Hangody et al. refer to a 1992 to 1994 comparison study of mosaicplasty and abrasion arthroplasty. No details of this study are provided, except to note that the mosaicplasty patients had significantly improved Hospital for Special Surgery (HSS) knee scores, compared with those undergoing abrasion arthroplasty. (1) A 2008 summary paper includes descriptions of a prospective multicenter comparison of 413 resurfacing procedures and follow-up from 1097 mosaicplasties at the authors’ institution. (5) Although the authors report that the comparative study found hyaline-like resurfacing to result in a better clinical outcome than other techniques, the cited study is not available as a publicly available peer-reviewed publication. For the retrospective analysis, Hangody et al. reported 789 implantations on the femoral condyles, 147 in the patellofemoral joint, 31 on the tibia condyles, 98 on talar domes, 8 on the capitulum humeric, 3 on humeral heads, and 11 on femoral heads. About two-thirds of the patients were reported to have had a localized cartilage lesion, and the remainder underwent surgery because of osteochondral defects. In 81% of patients, concomitant surgical interventions were performed; these included reconstruction of the anterior cruciate ligament (ACL) realignment osteotomies, meniscus surgery, and patellofemoral realignment procedures. Clinical scores found good-to-excellent results in 92% of patients with femoral condylar implantations, 87% of tibial resurfacings, 74% of patellar and/or trochlear mosaicplasties, and in 93% of talar procedures. Moderate and severe donor-site disturbances were reported in 3% of patients. Ninety-eight second-look arthroscopies were done for persistent or recurrent pain, swelling, or postoperative intra-articular bleeding (31 patients at 2 months to 11 years); second trauma (26 patients at 1-9 years); or to evaluate recovery in professional athletes (41 patients at 4-7 months). Although at least 57 (58%) second-look arthroscopies were associated with clinical symptoms, the report indicates that 81 (83%) of the evaluations indicated good gliding surfaces, histologically proven survival of the transplanted hyaline cartilage, and acceptable fibrocartilage covering of the donor sites. Slight or severe degenerative changes were seen at the recipient and/or donor sites in 17 cases (17%). The association between clinical symptoms and histological results was not discussed. Painful hemarthroses were observed in 56 (5%) patients. The authors note that although these results are encouraging for use of autologous osteochondral mosaicplasty as an alternative treatment for small- and medium-sized focal defects, postoperative bleeding from the empty donor tunnels represents a possible postoperative complication, and donor-site morbidity remains an open question. Based on their extensive experience with this procedure, Hangody et al. consider the optimal indications to be a lesion size of 1 to 4 cm2, patient age of 50 years or younger (due to decreased repair capacity with aging), and correction of instability, malalignment, and meniscal or ligamental tears. (5)
Osteochondral Autografts and Allografts for Focal Articular Cartilage Lesions of the Knee Comparative Trials
Osteochondral Autografts in Comparison with Microfracture
Three RCTs from the same group of investigators, 1 RCT with long-term follow-up, and 1 retrospective comparative trial, have been identified that compared outcomes following osteochondral autografting or microfracture.
Gudas et al. reported a well-controlled and blinded comparison of arthroscopic osteochondral autologous transplantation (OAT) versus microfracture for lesions of the femoral condyle (1-4 cm2) in 60 athletes between 15 and 40 years of age (mean, 24.3 years). (6) Follow-up on 95% of the athletes for up to 3 years after surgery showed that more athletes returned to sports activities (mean, 6.5 months) following OAT (93% versus 52%), and fewer required revision (1of 28 versus 9 of 29, both respectively). Overall, 96% of patients treated by OAT had an excellent or good result compared with 52% treated by microfracture. At 1-year follow-up, scores on the International Cartilage Repair Society (ICRS) cartilage grading system improved from a baseline of 51 to 86 in the OAT group and 76 in the microfracture group. At 3-year follow-up, scores from HSS questionnaires improved from a baseline of 77 to 91 in the OAT group and 81 in the microfracture group. No donor-site morbidity was observed. Blinded arthroscopic and histologic assessment in a subset of patients showed hyaline cartilage of normal appearance following transplantation, whereas microfracture was frequently observed to result in surface fibrillation and soft fibroelastic tissue. At 10-year follow-up, there were 4 failures (14%) in the OAT group and 11 failures (38%) in the microfracture group. (7) The Tegner scores decreased in both groups over time, but remained significantly better following OAT than microfracture. In the subgroup of patients who were younger than 25 years of age at the time of surgery, 15 of 20 patients (75%) in the OAT group and 8 of 22 patients (37%) in the microfracture group maintained the same level of activity (competitive athletes or frequently sporting) as before the injury. The level of sporting activity was reported to decrease in older patients because of age or other reasons not related to their knee.
Another report by Gudas et al. was a comparison of mosaicplasty versus microfracture or débridement. One hundred two patients with lesions associated with ACL injury were randomized to 1 of the 3 procedures in association with ACL repair. (8) A matched control group of 34 patients with ACL injury but no articular cartilage lesion was included for comparison. The postoperative rehabilitation protocol was the same for the 3 treatment groups. At a mean 36.1-month follow-up, patients were evaluated with the International Knee Documentation Committee (IKDC) score, Tegner activity score, and clinical assessment. All groups showed a significant improvement in the IKDC score compared with before surgery. Patients without cartilage lesions had IKDC subjective scores that were significantly better than patients with cartilage lesions. For the 3 groups of patients with cartilage lesions, the mosaicplasty group’s IKDC subjective knee evaluation was significantly better than the microfracture or débridement groups, although the differences between the groups were modest. Tegner activity scores were similar for the mosaicplasty and microfracture groups (7.1 and 6.9, respectively), and slightly lower for the débridement group (6.2).
Gudas et al. also published a randomized trial of osteochondral transplantation (n=25) versus microfracture (n=25) in children 12 to 18 years of age (mean, 14.3 years). (9) Only children with grade 3 or 4 osteochondritis dissecans (OCD) defects of the femoral condyles were included in the study. The OCD defects were between 2 and 4 cm2 in area, and the mean duration of symptoms was 24 months. Follow-up was obtained in 94% of patients. After 1 year, the proportion of excellent to good outcomes was similar for the 2 groups (92% for osteochondral transplantation versus 86% for microfracture). However, after a mean 4.2 years of follow-up (range, 3-6 years), the microfracture group showed 9 failures (41% of 22). In comparison, there were no failures in the osteochondral transplantation group, and good to excellent outcomes were obtained in 83% of the children. Magnetic resonance imaging (MRI) at a mean 18 months after the operation showed no evidence of graft loosening or migration with excellent or good repair in 19 of 21 children (91%). In comparison, blinded evaluation showed excellent or good repair in 10 of 18 children (56%) after microfracture.
In 2014, Ulstein et al. reported a long-term randomized trial (median, 9.8 years; range, 4.9-11.4 years) of osteochondral transplantation versus microfracture. (10) A total of 25 patients with a lesion of the femoral condyle or trochlea, with an area between 2 and 6 cm2 and depth less than 10 mm, were enrolled. All 25 patients in the study completed the questionnaires at baseline and follow-up. There were no significant differences between the osteochondral transplantation and microfracture groups in patient-reported outcomes (Lysholm, Knee Injury and Osteoarthritis Outcome Score [KOOS]), muscle strength or radiologic outcome. The mean Lysholm score improved from 49.2 to 62.6 at follow-up for the osteochondral transplantation group and from 48.2 to 69.7 following microfracture. However, 4 of 11 patients in the microfracture group underwent a second cartilage procedure compared with none in the osteochondral transplantation group. Solheim et al. also found that at a mean of 12 years (range, 10-14 years) after microfracture, 45.5% of the 110 patients in their prospective cohort had poor outcomes, which included 43 patients who had additional surgery. (11)
Krych et al. reported a retrospective comparison of 96 patients treated with either mosaicplasty or microfracture for articular cartilage defects of the knee. (12) Outcomes were measured annually at 1, 2, 3, and 5 years. At the latest follow-up, there was no significant difference between the 2 groups in the 36-Item Short-Form Health Survey (SF-36) physical component, the Knee Outcome Survey activities of daily living, or IKDC scores. The mosaicplasty group showed a greater improvement in the Marx Activity Rating Scale at the 2-, 3-, and 5-year follow-up.
Osteochondral Autografts in Comparison with ACI
There are several RCTs that compare outcomes following treatment with osteochondral autografts or ACI.
Bentley et al. randomized 100 consecutive patients with symptomatic lesions of the knee (average, 4.7 cm2; range, 1-12 cm2) to ACI or mosaicplasty. (13) Seventy-four percent of lesions were on the femoral condyle, and 25% of lesions were on the patella. Ninety-four patients had undergone previous surgical interventions, and the average duration of symptoms before surgery was 7 years. Clinical assessment at 1 year showed excellent or good results in 98% of the ACI patients and 69% of the mosaicplasty patients. The mosaicplasty plugs showed incomplete healing of the spaces between the grafts, fibrillation of the repair tissue, and disintegration of the grafts in some patients. This finding may be related to both the relatively large lesion size and the unusual prominent placement of the plugs in this study, which was intended to allow contact with the opposite articular surface. With 6 patients lost to follow-up at a minimum 10 years after the index surgery, repair was found to have failed in 17% of patients treated with ACI and 55% of patients treated with mosaicplasty. (14)
Dozin et al. reported results from a multicenter RCT in which ACI was compared with mosaicplasty. (15) Forty-four subjects (61% male, 39% female) age 16 to 40 years (mean, 28.7±7.8 years), who had a focal, symptomatic chondral injury of Outerbridge grade III or IV with no previous surgical treatment, were randomly assigned to ACI or mosaicplasty 6 months after undergoing arthroscopic débridement. The average lesion size was 1.9 cm. Only 12 of 22 (54%) in the ACI group and 11 of 22 (50%) of the mosaicplasty group actually underwent the assigned procedure. Dropouts comprised 14 patients (32%) who reported spontaneous improvement following arthroscopy and did not undergo subsequent surgery, 5 who did not show up at the presurgery examination and could not be further traced, and 2 who refused surgery for personal reasons. Because of the substantial dropout rate, the original primary outcome measure, the mean Lysholm Scale assessed 12 months postsurgery was converted into a scale in which improvement was categorized by proportions of responders (Lysholm score <60, 60-90, and 90-100). With this scale, and including 10 patients who were cured by débridement (intention-to-treat analysis), the percentages of patients who achieved complete success were 89% (16/18 evaluable cases) in the mosaicplasty arm versus 68% (13/19 evaluable cases) in the ACI arm (test for trend, p=0.093). The high rate of spontaneous improvement after simple débridement raises questions about the appropriateness of additional surgical intervention in patients with small lesions similar to those included in this trial.
Horas et al. reported 2-year follow-up on a study of 40 patients (between 18 and 42 years of age) with an articular lesion of the femoral condyle (range, 3.2-5.6 cm2) who were randomly assigned to undergo either ACI or osteochondral autografting. (16) Eleven (28%) had received prior surgical treatment. The authors reported that both treatments resulted in an improvement in symptoms (85% of each group), although those in the osteochondral autografting group responded more quickly. Histomorphologic evaluation of 5 biopsy specimens at 2 years or less after transplantation indicated that the osteochondral cylinders had retained their hyaline character, although the investigators noted a persistent interface between the transplant and the surrounding original cartilage. Evaluation of autologous chondrocyte implants indicated a rigid elastic tissue, with partial roughening and the presence of fibrocartilage.
Autologous Minced Cartilage
In 2011, Cole et al. reported a multicenter trial with 29 patients (of 582 screened) randomized in a 1:2 ratio to microfracture or Cartilage Autograft Implantation System (CAIS). (17) In the single-stage CAIS procedure, autologous hyaline cartilage was harvested, minced, affixed on a synthetic absorbable scaffold, and then fixed on the lesion site with absorbable staples. At baseline, there were no significant differences between groups in the duration of symptoms, ICRS grade, and area and depth of the chondral defect. There was a difference in the sex and work status of the 2 groups. At 3-week and 6-month follow-ups, there were no significant differences in outcomes between the 2 groups, but, at later time points, there were differences reported. The IKDC score was significantly higher in the CAIS group compared with the microfracture group at both 12 (73.9 versus 57.8) and 24 (83.0 versus 59.5) months. All subdomains of the Knee Injury and Osteoarthritis Outcome Score Symptoms and Stiffness, Pain, Activities of Daily Living, Sports and Recreation, Knee-related Quality of Life were significantly increased at 24 months in the CAIS group compared with microfracture patients. Qualitative analysis of MRI at 3 weeks and 6, 12, and 24 months showed no differences in fill of the graft bed, tissue integration, or presence of subchondral cysts. Adverse events were similar for the 2 groups.
There are a number of observational studies that provide additional information, including longer follow-up following treatment with osteochondral autografts and allografts and factors (i.e., patient age at the time of surgery, size and location of lesion) associated with good or poor outcomes.
Ollat et al. reported a retrospective multicenter study from the French Society of Arthroscopy that included 142 patients and a mean follow-up of 8 years. (18) (The authors comment that this technique has been used extensively in France due to restrictive legislation on restoration techniques, including chondrocyte transfer.) The mean size of the lesion was 2.29 cm2, and the most common etiologies were osteochondral fractures (n=79) and OCD (n=61). The mean number of plugs was 4 (range, 1-14). Postoperative complications occurred in 19 patients (13%). Most patients (81.8%) were satisfied or very satisfied with the functional outcomes. There was a significant improvement in the ICRS, IKDC function, and Hughston scores at follow-up. The factors for a good prognosis were found to be: male sex, location of the defect in the medial femoral condyle, OCD, deep, small defects, and a short interval before surgery. Obesity, smoking, work-related accidents, level of sports practiced, the percentage of coverage of the defect, the number of plugs, and associated lesions did not have a statistically significant effect on the functional results in the final follow-up.
Solheim et al. reported 5- to 9-year (n=69) and 10- to 14-year (n=73) follow-up from patients treated for articular cartilage defects of the femoral condyle, patella, or trochlea. (19, 20) Exclusion criteria were joint space narrowing, axial malpositioning, ligament instabilities, or inability to follow the rehabilitation protocol. A median of 4 grafts (range, 1-11) were used to treat lesions that ranged in size from 1 to 5 cm2. The Lysholm score improved from 49 at baseline to 72 at mid-term follow-up and remained at 72 at the 10- to 14-year follow-up. Visual analog scale (VAS) score for pain improved from 58 at baseline to 27 at mid-term follow-up and 33 at long-term follow-up. Poor outcome, defined as a Lysholm score of 64 or less, or subsequent knee replacement, was observed in 40% of the patients by 10 to 14 years after osteochondral autografting. Factors associated with a poor outcome were patient age of 40 years or older at the time of surgery, female sex, and articular cartilage defects of 3 cm2 or more. The failure rate was 83% for females 40 years or older with a defect area of 3 cm2 or more, compared with a failure rate of 12.5% for males younger than 40 years old with an articular cartilage defect less than 3 cm2. The location of the lesion (patellofemoral versus condylar) was not a significant factor for good versus poor outcome.
Other reports have focused on osteochondral transplantation for treating patellar lesions. In 2014, Astur et al. reported a prospective study of 33 patients with symptomatic patellar lesions (diameter, 1-2.5 cm) treated with osteochondral autografting. (21) Patients were excluded if they had a patellar tilt abnormality, a patella alta, or a patella baja, a greater than 15-mm distance of the tibial tubercle and trochlear groove, ACL injury, or a meniscal tear. A single osteochondral plug was used in 85% of cases. At a minimum 2- year follow-up (range, 24-54 months), all patients were reported to have significant improvement in functional scores, as measured by the Lysholm, Kujala, and Fulkerson scores and the SF-36 life quality score. MRI at 2 years showed full bone-plug integration into the patella. Nho et al. reported average 29-month follow-up following patellar resurfacing with osteochondral autografts in 22 patients. (22) Indications for surgery were patellofemoral malalignment, isolated cartilage lesion, OCD, or patellar dislocation. Concomitant procedures, including patellar realignment, were performed according to surgeon preference. The mean lesion size was 1.6 cm2, filled with an average 1.8 plugs per defect. The IKDC score improved from 47 preoperatively to 74 at follow-up. The activity of daily living score increased from 60 preoperatively to 85 at follow-up.
Laprell and Petersen reported 6- to 12-year follow-up from 29 of 35 patients (83%) with severe osteochondral defects (77% with OCD) who were treated by autologous osteochondral transplantation. (23) The average age of the patients at the time of surgery was 26 years. Clinical evaluation at an average 8 years after the procedure found 12 patients (41%) to be normal, 14 (48%) as nearly normal, and 3 (10%, all of whom refused correction of malalignment) as abnormal. No patient was assessed as severely abnormal. In contrast, no patients considered their functional status to be normal, 3 (10%) considered function to be nearly normal, 20 (69%) thought their function abnormal, and 6 (21%) considered their functional status to be severely abnormal. Another report described 7-year follow-up on 30 patients who had been treated with autologous osteochondral transplantation for symptomatic grade III to IV chondral lesions (average, 1.9 cm; range, 1.0-2.5 cm). (24) Nineteen patients received other procedures (ACL reconstruction, meniscectomy, medial collateral ligament repair) at the same time. MRI at 7 years showed complete bone integration in 96% of patients, complete integration of the grafted cartilage in 75% of cases, complete filling of the cartilage defect in 63% of the patients, and congruency of the articular surface in “some” patients. Subchondral bone changes (edema or sclerosis) were noted in 71% of patients. The donor sites were filled with a tissue of different density than the surrounding bone, presumed to be fibrous tissue.
A 2015 systematic review by De Caro et al. included 11 articles that had at least 10 patients and were published in the previous 5 years. (25) There were a combined total of 374 knees in 358 patients treated with osteochondral allografting. The size of the lesions ranged from 1 to 27 cm2. Different outcome measures were used, but overall results showed improvement in objective and subjective clinical scores, a high rate of return to some level of sport or active duty, and a graft survivorship rate of 82% at 10 years and 66% at 20 years. Although bony integration was usually achieved, cartilage integration was limited. In a 2015 review of indications, techniques, and outcomes, Chui et al. state that osteochondral allografting is indicated for lesions greater than 2 cm2 for which other techniques such as microfracture, osteochondral autograft transplantation, and ACI are inadequate due to the size, location, or depth of the lesion. (26) These authors also consider osteochondral allografting to be a salvage procedure for previously failed restoration treatments of the knee.
Long-term outcomes with osteochondral allografting have been reported in other case series. Emmerson et al. reported mean 7.7-year follow-up (range, 2-22 years) from 66 knees of 64 patients who underwent fresh osteochondral allografting for the treatment of OCD of the femoral condyle. (27) All patients had undergone previous surgery, with an average of 1.7 prior surgeries on each knee. The mean allograft size was 7.5 cm2. One knee was lost to follow-up. Of the remaining 65 knees, 10 patients (15%) underwent reoperation, 47 (72%) were rated good to excellent, and 8 (13%) were rated fair to poor. Kaplan-Meier survival analysis demonstrated 91% graft survival at 5 years and 76% graft survival at 10 and 15 years. The mean D’Aubigne and Postel score improved from 13.0 (fair) preoperatively to 16.4 (good) at the most recent follow-up. Subjective knee function improved from a mean of 3.4 to 8.4 on a 10-point scale.
Gross et al. reported minimum 5-year follow-up on a series of 60 patients who received femoral condylar grafts and 65 patients who received tibial plateau grafts for knee defects. (28) Eligible recipients of allografts were younger than 60 years and had traumatic unipolar osteochondral defects of at least 3 cm in diameter and 1 cm deep. If the meniscus was also significantly damaged, it was resected and replaced with allograft meniscus. Realignment of the involved leg was also performed to unload the graft. Patients were assessed preoperatively and postoperatively using the modified Harris Hip Score (HSS) score. If there was no outcome data in the database within the last 12 months, the patients were contacted and a follow-up visit was arranged or a questionnaire was administered by telephone. Referring physicians were also contacted to obtain recent radiographs of the knee. Follow-up was obtained on 86% of patients who received a femoral graft (average, 10 years), and 97% of patients with a tibial graft (average, 11.8 years). For the femoral grafts, 12 failed and required graft removal or conversion to total knee replacement. At the end of the study period, 48 of the 60 femoral grafts (80%) were in situ with an average HSS score of 83 out of 100. Kaplan-Meier survival analysis showed 95% graft survival at 5 years, 85% at 10 years, and 74% at 15 years. For the tibial grafts, 21 failed at a mean interval of 9.7 years. At the end of the study, 44 of 65 tibial grafts (68%) were in situ and functioning with an HSS greater than 70 points. Survival analysis revealed 95% graft survival at 5 years, 80% at 10 years, and 65% at 15 years.
Osteochondral allografting for patellar cartilage injury was reported by Gracitelli in 2015. (29) Of 28 knees (27 patients) that had osteochondral transplantation, 8 (28.6%) were considered failures and 9 (45%) required further surgery. Allograft survivorship was estimated to be 78.1% at 10 years and 55.8% at 15 years. The mean follow-up duration was 9.7 years (range, 1.8-30.1 years) for the 20 knees (71.4%) with intact grafts.
Allogeneic Juvenile Minced Cartilage
Evidence on the efficacy of DeNovo NT is limited to case reports and small case series. The largest series identified was an industry-sponsored prospective study by Farr et al., which included 25 patients with cartilage lesions of the femoral condyle or trochlea (NCT00791245). (30) Patients had symptomatic, focal, contained chondral lesions of the femoral condyles or trochlea with defect areas ranging between 1 cm2 and 5 cm2 (mean, 2.7 cm2; range 1.2-4.6 cm2). The mean number of prior surgeries was 1.1, with 18 patients reporting prior débridement and/or microfracture. Patients returned for follow-up at 3, 6, 12, 18, and 24 months for radiographs, IKDC examination, and completion of questionnaires. Outcomes included the KOOS, IKDC, Marx Activity Scale, and 100-mm VAS for pain. The IKDC improved over the 24 months of follow-up. At 24 months, IKDC had improved from 45.7 preoperatively to 73.6 of 100. There were also significant improvements in KOOS subscores (p<0.001) and VAS pain score (from 43.7/100 at baseline to 11.1 at 24 months, p<0.001). MRI showed a mean lesion fill of 109.7% with mild graft hypertrophy identified in 20.7% of patients. Of 11 elective second look arthroscopies at 24 months, 2 grafts (18%) showed either partial or complete delamination. Histology from 8 patients with biopsy showed a mixture of hyaline and fibrocartilage; areas with hyaline cartilage were variable across the sections. There was good integration with the surrounding native cartilage.
A 2013 study included 13 patients (15 knees) who received particulated juvenile allograft to the patella. (31) Ten of the 15 knees underwent concomitant procedures, limiting interpretation of functional outcomes. Cartilage repair assessed at a mean of 28.8 months was reported to be nearly normal in 73% of knees while 27% of knees had evidence of graft hypertrophy. Currently available evidence is insufficient to evaluate the effect of this technology on health outcomes.
One small RCT and several case series have been identified on osteochondral autografting for lesions of the talus. The literature on osteochondral allografts for lesions of the talus consists mainly of small case series.
Zengerink et al. published a systematic review of treatment of osteochondral lesions of the talus in 2010. (32) Fifty-one nonrandomized and 1 randomized trial were included in the review. Success rates averaged 85% for bone marrow stimulation, 87% for osteochondral autografting, and 76% for ACI. Because of the high cost of ACI and the knee morbidity seen with osteochondral autografting, the authors concluded that bone marrow stimulation is the treatment of choice for primary osteochondral talar lesions. A 2009 report examined the association between defect size and outcomes following marrow stimulation techniques in 120 ankles. (33) Eight ankles subsequently underwent osteochondral transplantation and 22 ankles were considered clinical failures (American Orthopaedic Foot and Ankle Society [AOFAS] Ankle-Hindfoot score <80). Linear regression suggested a cutoff defect size of 1.5 cm2 for marrow stimulation techniques, with an 80% failure rate compared with a 10.5% failure rate for ankles with a defect size less than 1.5 cm2. Three of 58 ankles (5.2%) with a defect area less than 1 cm2 showed clinical failure, while 7 of 37 ankles (18.9%) with a defect area between 1.0 and 1.5 cm2 had failed.
The sole controlled trial that has been identified randomized 32 patients with osteochondral lesions of the talus to chondroplasty, microfracture, or the Osteochondral Autograft Transfer System (OATS). (34) This study found similar improvements (»40 points) for the 3 treatment groups, as measured by the AOFAS Ankle-Hindfoot Score (baseline score, 31-37) and the Subjective Assessment Numeric Evaluation (baseline score, 35-36). Complication rates were also similar, with persistent pain reported by 1 patient following chondroplasty, by 2 patients following microfracture, and by 2 patients following OATS. Postoperative pain, measured by numeric pain intensity scores, was greater following OATS (5.25) than chondroplasty (3.3) or microfracture (3.4).
A prospective, uncontrolled study of 32 patients who underwent open osteochondral autografting of the talus for OCD was reported in 2012. (35) The osteochondral grafts were harvested from the ipsilateral knee and placed in the talus after medial malleolar osteotomy. At baseline, the average AOFAS score was 59.1. At a mean 16.8 months of follow-up (range, 12-24 months), the AOFAS score had improved to 87.9. All patients showed an improvement of at least 20 points. The Lysholm score, used to assess donor site morbidity, was 88 points at 6 weeks postoperatively and 98 points at 6 months. Two patients had persistent knee pain at the last follow-up.
In 2006, Scranton et al. reported a study of 50 consecutive patients with a type-V cystic talar defect who were treated with a single osteochondral graft (15 mm) taken from the ipsilateral knee. (36) Patients with larger lesions in which multiple allograft plugs were used were excluded from analysis. Thirty-two patients (64%) had undergone a previous surgical procedure on the ankle; further surgery was required in 17 patients (34%). When contacted at a mean of 36 months (range, 24-83 months) after the index procedure, 45 patients (90%) had a good-to-excellent score on the Karlsson-Peterson Ankle Score questionnaire. Two patients had severe degenerative changes and underwent arthrodesis.
In 2006, Kreuz et al. reported outcomes from a series of 35 patients who underwent osteochondral grafting from the ipsilateral talar articular facet (with or without osteotomy) following failed bone marrow stimulation. (37) Six of the patients had previously undergone osteochondral or cancellous bone grafting of the defect area. The mean lesion size was 6.3 mm. At a mean follow-up of 49 months (range, 33-77 months), the AOFAS Ankle-Hindfoot score had improved from 54.5 (range, 47-60) to 89.9 points (range, 80-100).
In 2011, Imhoff et al. reported a retrospective review with long-term outcomes following osteochondral autografts of the talus in 28 consecutive patients. (38) The osteochondral grafts were harvested from the femoral condyles and malleolar osteotomies were performed whenever the osteochondral defect could not be reached from the anterior incision. One patient was lost to follow-up, and 2 patients had a revision operation on the ankle. For 16 of the remaining 25 patients (64%), the autograft was the first line of treatment, and in 9 patients (36%), it was a second surgical intervention. Between baseline and average 7 years of follow-up (range, 53-124 months), the AOFAS score increased from 50 to 78 points, the Tegner score increased from 3.1 to 3.7, and the VAS for pain decreased from 7.8 to 1.5. Patients who had transplant as a second procedure had significantly worse AOFAS (62 versus 87) and Tegner scores (2.0 versus 4.6) and higher VAS scores (3 versus 0.6, all respectively).
Hangody et al. reported 2- to 7-year follow-up in 36 consecutive patients treated with osteochondral autografting for OCD of the talus. (39) Most of the patients had previous surgical interventions and presented with stage III or IV lesions (completely detached or displaced fragment). The average size of the defect was 1 cm, and the average number of grafts per patients was 3 (range, 1-6). At mean follow-up of 4.2 years, ankle function measured by the Hannover scoring system showed good to excellent results in 34 cases (94%). Examination by radiograph, computed tomography (CT), and MRI showed incorporation into the recipient bed and congruency of the articular surface.
In 2011, Liu et al. reported osteochondral autografting in 16 patients for acute osteochondral fractures of the talar dome associated with an ankle fracture. (40) Ankle radiographs were taken at 2, 6, and 12 weeks postoperatively and every 3 months after fracture healing. MRI was performed after 12 months and at the latest follow-up. At an average 36-month follow-up (range, 21-48 months), the AOFAS score was 95.4 (range, 86-100). At the latest follow-up, there was no radiographic evidence of posttraumatic arthritis, and MRI showed bony integration and articular congruity of the talar dome in 93.7% of the osteochondral grafts.
Donor Site Morbidity
One study evaluated donor-site morbidity in 11 of 15 patients who had undergone graft harvest from the knee (mean, 2.9 plugs) for treatment of osteochondral lesions of the talus. (41) At an average 47-month follow-up (range, 7-77 months), 5 patients were rated as having an excellent Lysholm score (95-100 points), 2 as good (84-94 points), and 4 as poor (≤64 points). Reported knee problems were instability in daily activities, pain after walking 1 mile or more, having a slight limp, and difficulty squatting. Hangody et al. reported that some patients had slight or moderate complaints with physical activity during the first postoperative year, but there was no long-term donor site pain in a series of 36 patients evaluated 2 to 7 years after osteochondral autografting. (39) A 2009 report from Europe described osteochondral autografting for lesions of the talus in 200 patients, 112 of whom had been followed up for a minimum of 2 years. (42) The focus of this study was to determine factors contributing to donor-site morbidity in the knee, rather than outcomes for the talus. The number of grafts, size of the transplanted plugs, and patient age were not related to donor-site morbidity. Body mass index (BMI) was found to be significantly associated with knee scores, with a decrease in Lysholm score by 1 point (1%) for each point increase in BMI. Interpretation of these results is limited by the lack of preoperative assessment of knee pain and function.
Use of allografts for large defects of the talus has been reported in case series. Due to the relatively rare occurrence of this condition, most series have fewer than 20 patients.
The largest series is from Bugbee et al., who reviewed outcomes of 86 ankles (82 patients) treated with bipolar fresh osteochondral allografts for arthritis of the tibiotalar joint. (43) All patients had declined arthrodesis. Patients who did not present for follow-up were contacted via telephone and/or mail to obtain subjective outcomes. At a mean follow-up of 5.3 years (range, 2-11 years), 36 ankles (42%) had undergone additional surgery. Twenty-five ankles (29%) were considered clinical failures (i.e., revision allograft, conversion to total ankle arthroplasty, arthrodesis, amputation) and 11 ankles (13%) had undergone operations that did not involve graft removal. Radiographic evaluation categorized 29 of 63 ankles (46%) as failures, with graft collapse observed in 11 of the 29 (38%). Survivorship of the osteochondral allograft estimated by Kaplan-Meier analysis was 76% at 5 years and 44% at 10 years. For patients who did not undergo additional surgery, 62% were classified as having excellent-to-good results, 26% as fair, and 12% as poor.
In 2012, Haene et al. reported a prospective study of fresh talar osteochondral allografts in 16 patients (17 ankles) with large osteochondral lesions of the talus. (44) All but 1 of the ankles had previously undergone single or multiple procedures. CT at an average follow-up of 4.1 years (range, 2-6 years) identified failure of graft incorporation in 2 ankles, osteolysis in 5, subchondral cysts in 8, and degenerative changes in 7 ankles. Clinically, 5 ankles (29%) were considered failures, and 2 (12%) had poor outcomes requiring additional surgery. Ten ankles (59%) had good-to-excellent results based on validated outcome scores and clinical history.
Berlet et al. reported a 2011 prospective study with minimum follow-up of 2 years in 12 patients who had received an osteochondral allograft for talar defects. (45) In another patient, the graft had failed and was not included in the analysis. All patients had failed at least 1 prior surgical treatment and had a mean lesion size of 1.5 cm2. At follow-up (mean, 3.3 years), AOFAS Ankle-Hindfoot scores improved from 61 at baseline to 79. There was a trend toward improvement in the physical or mental health components of the SF-12 Health Survey, although the study was underpowered to detect a significant difference. Radiographs and MRI performed yearly showed radiolucencies in 3 grafts (25%), edema in 4 (33%), and failure to incorporate for 1 graft.
El-Rashidy et al. reported a retrospective review of 38 of 42 total patients who were treated with osteochondral allografts. (46) All patients had failed conservative management and had a mean lesion size of 1.5 cm2. Grafts were harvested from a similar anatomic location on the donor talus to match the contour and surface anatomy of the recipient bed. The average duration of follow-up was 38 months. Including scores from 4 patients (10.5%) in whom graft failure occurred, the AOFAS Ankle-Hindfoot score improved from 52 to 79 points and VAS improved from 8.2 to 3.3 points. Patient satisfaction with the outcome was rated as excellent, very good, or good by 28 of the 38 patients (74%) and as fair or poor by 10 patients (26%). Of the 15 patients who had postoperative MRI, 5 (33%) had signs of graft instability.
Raikin published results from a series of 15 patients who underwent fresh matched osteochondral allograft transplantation for talar lesions with a volume greater than 30 cm3. (47) At an average 54 months after surgery (minimum of 2 years), mean VAS for pain had improved from 8.5 to 3.3 and the mean AOFAS Ankle-Hindfoot score had improved from 38 to 83 points. Two ankles had undergone conversion to fusion. Radiographic analysis revealed some evidence of collapse or resorption in 10 of the 15 ankles (67%).
Gortz et al. reported on a series of 11 patients (12 ankles) who underwent fresh osteochondral allografting for unipolar lesions of the talus. (48) Patients had undergone an average of 1.8 prior surgeries (range, 1-5). The average graft size was 3.6 cm2, which was an average of 40.5% of the talar surface. At a mean 38- month follow-up (range, 24-107 months) 2 of the ankles had failed and undergone revision or fusion. For the remaining 10 patients, the mean Olerud-Molander Ankle Score improved from a score of 28 to 71. Outcomes were categorized at good to excellent in 5 ankles (42%), fair in 3 (25%), and poor in 2 (17%). All patients demonstrated radiographic union by 6 months, with an overall graft survival rate of 83%.
Allogeneic Juvenile Minced Cartilage
Use of DeNovo NT for the talus has been reported in small case series. The largest series is from a preliminary report of a larger study. (49) The full multicenter study has a targeted enrollment of 250 patients with 5-year follow-up. In the preliminary report, 24 ankles (23 patients) with osteochondral lesions of the talus were treated with DeNovo NT. Fourteen of the ankles (58%) had failed at least 1 prior bone marrow stimulation procedure. At an average follow-up of 16.2 months, 78% of ankles had good-to-excellent scores on the AOFAS Ankle-Hindfoot scale with a final mean VAS of 24/100. However, 18 ankles (76%) had at least 1 concomitant procedure (hardware removal and treatment for impingement, synovitis, instability, osteophytes, malalignment), limiting interpretation of the functional results. There was 1 treatment failure caused by partial graft delamination. Bleazey and Brigado conducted a retrospective review of 7 patients who were treated with juvenile minced cartilage (DeNovo NT) together with sponge allograft. (50) All patients had failed conservative therapy (walking boot and physical therapy), and 4 patients had failed microfracture. Patients were evaluated with VAS for pain and activity at 6-month follow-up. All patients showed clinically significant improvement. Pain during walking decreased from an average of 7.7 at baseline to 1.9 at 6 months. Ability to walk 4 blocks improved from a score of 4.8 to 9.2.
OCD of the Elbow
OCD of the elbow is an uncommon condition that in its early stages can be treated nonoperatively or with simple fragment removal. (51) The literature on osteochondral autografts for advanced OCD of the elbow consists of small case series, primarily from Europe and Asia.
Iwasaki et al. reported minimum 2-year follow-up after osteochondral mosaicplasty for OCD of the elbow in 19 teenage athletes (mean age, 14 years) in Japan. (52) Preoperative symptoms consisted of pain with sports activities (n=19), limited range of motion (n=5), and elbow catching (n=3). Indications for surgery included failure of more than 6 months of conservative treatment or evidence on plain radiographs and MRI of unstable lesions, such as displaced (n=7) or detached (n=12) fragments. The mean defect size was 1.5 cm2 (range, 0.5-3.0 cm2). Two independent observers assessed clinical findings at a mean of 45 months (range, 24-87 months); the radiologist was blinded to the clinical outcomes. Graft incorporation was observed in all patients, with nearly normal surface integrity of the articular cartilage and underlying bone in 18 patients. Eighteen of the 19 patients were classified with good-to-excellent results and were free from elbow pain. One patient was classified as fair with mild pain. Seventeen of the 19 patients, including all pitchers, returned to a competitive level of baseball. Mild donor site pain in the knee was reported in 1 patient.
Yamamoto et al. reported minimum 2-year follow-up (range, 24-63 months) from 18 juvenile baseball players with OCD of the elbow who were treated with osteochondral autografts. (53) Most of the patients had failed conservative management at another hospital in Japan. For grade 3 lesions (separated but in situ), 1 or 2 osteochondral plugs from the femoral condyle or patellofemoral joint were used to restore the articular surface or fix unstable OCD lesions. For grade 4 lesions (displaced fragment), 1 to 3 plugs were used to restore the articular surface. For the 9 patients with a grade 3 lesion, the subjective score was increased (from 75.0 to 95.6), but the objective score (from 88.3 to 88.3) did not change. For the 9 patients with a grade 4 lesion, both subjective (from 65.6 to 88.9) and objective scores (from 72.8 to 88.3) were increased significantly. At 6 months after surgery, all patients but 1 could throw a ball without pain.
In 2011, Ovesen et al. reported mean 30-month follow-up from 10 patients (age, 13-27 years) treated with osteochondral autografts from the lateral patellofemoral joint for advanced OCD of the elbow. (54) Eight of the patients (80%) were pain-free postoperatively. The Mayo Elbow Performance Score improved from a preoperative mean of 71 points to 93.5 points postoperatively. This compared with a score of 100 points for the non-operated elbows. The Constant functional elbow score averaged 92.5 points for the operated elbow and 100 for non-operated elbows. Postoperative radiographs and MRI/CT showed incorporation and a normal contour of the subchondral cortex in all patients. No problems were observed regarding donor site pain.
A clinical review was published in 2012 by Smith et al. (60) For adolescent patients, unstable OCD of the capitellum remains controversial when managed surgically. Unstable defects requiring surgical intervention includes fragment fixation, debridement or reconstruction. The authors concluded high-level evidence is lacking to determine the superiority of debridement or osteochondral autografting for the treatment of capitellar OCD. Larger studies are needed to validate outcome measures to establish the optimal treatment of this type of injury. To date, studies are anecdotal, small with 20 patients or less and reported outcomes equivalent to the Smith et al. described earlier.
Donor Site Morbidity
Nishimura et al. evaluated recovery of the donor knee after osteochondral autograft harvesting for capitellar OCD in 12 young athletes (age range, 12-17 years). (55) Pain and function were assessed at 1, 2, 3, 6, 12, and 24 months after the surgery. Knee joint effusion persisted in 7 of the 12 patients at 1 month, but none of the patients had effusion at 3 months. At 3 months, muscle power of the knee extensor was reduced in 8 patients compared with the preoperative level. At 12 months, 11 patients had reached preoperative knee extensor muscle strength. All patients were pain-free at the donor site by 6 months (mean Lysholm score, 100) and returned to the previous competitive level of their sport.
A European study reported 9-year follow-up after osteochondral autografting for cartilage defects of the shoulder in 7 patients. (56) One additional patient was reported to have had donor-site morbidity at the knee and chose not to return for follow-up. All of the plugs showed full integration with the surrounding bone, and 6 of 7 patients showed a congruent joint surface. The Constant score improved from 76 preoperatively to 90 points at 33 months and remained at 91 points at the 9-year follow-up. Subscores for pain and activities of daily living showed significant improvement at 33-month follow-up, with a very slight nonsignificant decline at 9-year follow-up. None of the patients required additional shoulder surgery.
Ongoing and Unpublished Clinical Trials
Some currently unpublished trials that might influence this policy are listed in Table 1.
Table 1. Summary of Key Trials
Long Term Outcomes of Osteochondral Allografts for Osteochondral Defects of the Knee
Post Market, Longitudinal Data Collection Study of Articular Cartilage Lesions in the Ankle Treated With DeNovo (R) NT
Post Market, Longitudinal Data Collection Study of DeNovo NT for Articular Cartilage Defects of the Knee
A Post Market Study to Evaluate the Chondrofix® Osteochondral Allograft Utilized for Treatment of Subjects With Cartilage Lesions in the Knee
NCT: National Clinical Trial.
a: Denotes industry-sponsored or cosponsored trial.
Clinical Input Received through Physician Specialty Societies and Academic Medical Centers
In 2008 Blue Cross Blue Shield Association (BCBSA) requested and received clinical input from 1 physician specialty society and 3 academic medical centers. All reviewers agreed that osteochondral autografts and allografts are considered reasonable for patients with full-thickness chondral defects who meet specific criteria.
Again in 2011, BCBSA requested and received clinical input from 3 academic medical centers. The clinical input was generally in agreement with the stated criteria for osteochondral grafting with the exception of the following: input was mixed regarding the requirement for an inadequate response to a prior surgical procedure, the size of the lesion, and the requirement for an absence of meniscal pathology. Input was also mixed regarding the investigational status of osteochondral grafts in other joints, including the patellar and talar joints, and for the use of autologous minced cartilage.
Practice Guidelines and Position Statements
American Academy of Orthopaedic Surgeons (AAOS)
In 2010 and 2012 clinical practice guidelines on the diagnosis and treatment of OCD, the AAOS was unable to recommend for or against a specific cartilage repair technique in symptomatic skeletally immature or mature patients with an unsalvageable OCD lesion. (57, 58)
National Institute for Health and Clinical Excellence (NICE)
The Interventional Procedures Advisory Committee of the United Kingdom’s NICE conducted a 2005 review of mosaicplasty for knee cartilage defects. (59) The corresponding NICE Guidance on mosaicplasty, released in 2006, (60) stated that “There is some evidence of short-term efficacy, but data on long-term efficacy are inadequate.”
Evidence is sufficient to consider osteochondral allografting medically necessary as a technique to repair full-thickness chondral defects of the knee caused by acute or repetitive trauma when other cartilage repair techniques (e.g., microfracture, osteochondral autografting or autologous chondrocyte implantation) would be inadequate due to the size, location, or depth of the lesion. Evidence is insufficient to evaluate the effect of osteochondral allografting of the talus, or other joints, on health outcomes.
For osteochondral autografting, only 3 relatively small randomized controlled trials from the same investigators in Europe have demonstrated improved clinical outcomes with osteochondral autografting of the knee when compared with microfracture. However, controlled studies demonstrate similar benefit to other cartilage resurfacing procedures in appropriately selected patients, and a number of uncontrolled studies indicate that osteochondral autografts can improve symptoms in some patients with focal lesions of articular cartilage of the knee who have failed prior surgical treatment. These patients have limited options. Therefore, based on the clinical input received and additional literature reviewed, it is concluded that osteochondral autografts may be considered an option for symptomatic full-thickness chondral lesions of the femoral condyle, trochlea, or patella caused by acute or repetitive trauma, in patients who have had an inadequate response to a prior arthroscopic or other surgical repair procedure. Recent evidence indicates that osteochondral grafting combined with meniscal allograft results in outcomes similar to either procedure performed alone.
Evidence is currently insufficient to evaluate the efficacy of osteochondral autografts for joints other than the knee, or to evaluate the efficacy of osteochondral autografts in comparison with other surgical repair procedures as a primary treatment of small lesions. Questions also remain about the natural history of asymptomatic lesions found incidentally during other surgical procedures. Controlled trials with longer follow-up are needed to demonstrate that use of osteochondral autografts as a primary treatment results in improved clinical outcomes in comparison with traditional marrow-stimulating procedures.
Minced cartilage techniques are either not approved in the United States and/or in the early stages of development and testing (e.g., particulated juvenile articular cartilage). Early results from case series appear to show similar outcomes compared with other treatments for cartilage defects, but these case series do not permit conclusions regarding the effect of this treatment on health outcomes. Further studies with a larger number of patients and longer follow-up are needed, especially randomized controlled trials that directly compare particulated juvenile articular cartilage with other established treatments.
Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.
This service should not be confused with autologous chondrocyte implantation (ACI); however, providers may use 29866 when billing ACI. The claim should be reviewed for osteochondral autografting and allografting when 27416, 29866 or 29867 are billed, as these codes reflect the mosaicplasty procedure(s).
Disclaimer for coding information on Medical Policies
Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.
The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.
Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage versus. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps.
The following codes may be applicable to this Medical policy and may not be all inclusive.
27415, 27416, 28446, 29866, 29867
ICD-9 Diagnosis Codes
Refer to the ICD-9-CM manual
ICD-9 Procedure Codes
Refer to the ICD-9-CM manual
ICD-10 Diagnosis Codes
Refer to the ICD-10-CM manual
ICD-10 Procedure Codes
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The Centers for Medicare and Medicaid Services (CMS) does not have a national Medicare coverage position. Coverage may be subject to local carrier discretion.
A national coverage position for Medicare may have been developed since this medical policy document was written. See Medicare's National Coverage at <http://www.cms.hhs.gov>.
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|12/15/2016||Document updated with literature review. The following was added to the medical necessity statement for osteochondral allografting: “when other cartilage repair techniques (e.g., microfracture, osteochondral autografting or autologous chondrocyte implantation) would be inadequate due to the size, location, or depth of the lesion.” The following was added to the medical necessity statement for osteochondral autografting: “in patients who have had an inadequate response to a prior surgical procedure” and to criterion regarding surrounding articular cartilage to state, “Documented minimal to absent degenerative changes in the surrounding articular cartilage (Outerbridge grade II or less), and normal-appearing hyaline cartilage surrounding the border of the defect.” Clarification wording was added to the medically necessary coverage statement and criteria.|
|2/1/2015||Document updated with literature review. The following was added to Coverage: 1) Addition to criteria to include Outerbridge grade III when lesion is discrete, single, unipolar, and full thickness; 2) NOTE - Osteochondral autograft or allograft transplantation may be medically necessary when performed in combination, either concurrently or sequentially, with meniscal allotransplantation for focal articular cartilage lesions; 3) NOTE - Additional procedures, such as repair of ligaments or tendons of an osteotomy for realignment (includes misalignment and instability) may be performed at the same time of the osteochondral autografting or allografting procedure; and 4) Treatment of focal articular cartilage lesions with autologous and/or allogeneic minced cartilage is considered experimental, investigational and/or unproven. Description, Rationale, and References substantially revised and reorganized. “Osteochondral” removed from the policy title.|
|2/15/2010||Revised/updated entire document, osteochondral autografting and allografting remain conditional based on medical necessity criteria. This policy is no longer scheduled for routine literature review and update.|
|1/1/2008||New CPT/HCPCS code added|
|8/15/2007||Revised/updated entire document|
|1/1/2005||Revised/updated entire document, originated from position statement|
|12/18/2001||New medical document|
|Title:||Effective Date:||End Date:|
|Autografts and Allografts in the Treatment of Focal Articular Cartilage Lesions||02-01-2018||07-14-2018|
|Autografts and Allografts in the Treatment of Focal Articular Cartilage Lesions||04-15-2017||01-31-2018|
|Autografts and Allografts in the Treatment of Focal Articular Cartilage Lesions||12-15-2016||04-14-2017|
|Autografts and Allografts in the Treatment of Focal Articular Cartilage Lesions||02-01-2015||12-14-2016|
|Osteochondral Autografts and Allografts in the Treatment of Focal Articular Cartilage Lesions||02-15-2010||01-31-2015|
|Osteochondral Autografts and Allografts in the Treatment of Focal Articular Cartilage Lesions||08-15-2007||02-14-2010|
|Osteochondral Autografts and Allografts in the Treatment of Focal Articular Cartilage Lesions||01-01-2005||08-14-2007|
|Osteochondral Grafts in the Treatment of Articular Cartilage Lesions||12-18-2001||12-31-2004|