Archived Policies - Surgery
Osteochondral Autografts and Allografts in the Treatment of Focal Articular Cartilage Lesions
Osteochondral autografting and allografting may be considered medically necessary for the treatment of cartilaginous defects caused by acute or repetitive trauma in the knee when the following criteria are met:
Osteochondral autograft or allograft transplantation for joints other than the knee is considered experimental, investigational and unproven, including but not limited to the ankle (talus).
Osteochondral autograft or allograft transplantation is considered experimental, investigational and unproven when the patient selection criteria cited above are not met.
Focal chondral defects of the knee, due to trauma or other conditions such as osteochondritis dissecans, 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 the symptoms, restore normal biomechanics of the knee joint, and prevent the long-term emergence of osteoarthritis and the necessity for total knee replacement. 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.
The use of both fresh and cryopreserved allogeneic osteochondral grafts has been encouraging. Cryopreservation decreases the viability of cartilage cells and fresh allografts may be difficult to obtain. There are concerns regarding infectious diseases when using allografts (from a donor other than the recipient). For these reasons, autologous (one's own tissue from one location to another) grafts have been under investigation as an option to increase the survival rate of the grafted cartilage and to eliminate the risk of disease transmission. Autografts have been limited by the small number of donor sites. Single grafts have been harvested from the patella, femoral condyle, and proximal part of the fibula. In an effort to extend the amount of available donor tissue, investigators have used multiple, small osteochondral cores harvested from various non-weight-bearing sites of the knee. These two separate procedures are Osteochondral Mosaicplasty and Osteochondral Autograft Transfer System (OATS).
In the mosaicplasty procedure, the chondral lesion is excised, and abrasion arthroplasty is performed to refresh the bone base of the defect. Multiple individual osteochondral cores are harvested from the donor site, typically from a peripheral non-weight-bearing area of the femoral condyle. The grafts are press fit into the lesion in a mosaic-like fashion within the same-sized drilled recipient tunnels. The resultant surface consists of transplanted hyaline cartilage and fibrocartilage arising from the abrasion arthroplasty. The fibrocartilage is thought to provide ‘grouting’ between the individual autografts. Mosaicplasty may be performed with either an open approach or arthroscopically if the lesion is small and not more than four to six grafts are needed.
The OATS procedure focuses on chondral defects that are associated with chronic tears of the anterior cruciate ligament (ACL), using an arthroscopic approach that can provide access to both the ACL for reconstruction and performance of the autograft. OATS has been used to treat lesions which are two centimeters or less in diameter. A newer OATS approach to large defects (20 millimeters to 35 millimeters) in the weight-bearing zone has been introduced as “Mega-OATS”. Earlier graft placement was secured with screw fixation; however, later fixation was secured as a press fit of the core plugs, eliminating the secondary hardware removal. Generally, Mega-OATS remains a salvage procedure.
Although Mosaicplasty and OATS may use different instrumentation, the underlying principle to obtain the autografts is the same and to transfer the cartilage or bone plugs from one area to another damaged area. The resurfacing concept is similar to a hair transplant. Clinical studies have begun by using osteochondral grafts to repair chondral defects of the hip, patella, tibia, and ankle.
The current medical literature regarding osteochondral allografting of the knee shows that this procedure has demonstrated acceptable long-term results measured by reduction in pain, improved physical function, and sustained osteochondral graft viability. Several long-term studies have demonstrated long-term donor osteochondral grafts viability up to 10 years and in one study as long as 14 years with a success rate reported at 63%. Shorter term studies have reported success rates of between 75-80%. The evidence indicates that osteochondral allografting has been highly successful in patients with chondral defects resulting from trauma or osteochondritis dissecans, but less so in patients with osteonecrosis or steroid induced lesions. Finally, the literature is unanimous in emphasizing the importance of proper patient selection including adequate joint stability and alignment.
Peer reviewed medical literature pertaining to OATS and mosaicplasty of the knee consists mostly of single-institution case series focusing on chondral lesions of the knee. These studies include heterogeneous populations of patients, some of whom are undergoing treatment for additional abnormalities such as ligament or meniscal repair. Therefore, it is not known whether improvement in symptoms can be attributed to the osteochondral autografting or other components of the surgery. In addition, there are very few studies currently available comparing the results of osteochondral autografting with other established therapies. However, there is a large collection of small studies that demonstrated that osteochondral autografting procedures, including mosaicplasty, confer significant benefit in terms of both functional improvement and pain relief in a population where alternative therapies are limited. Several studies have evaluated the long term viability of osteochondral autografts with histological examinations at up to three years post-transplant. The vast majority of these studies report finding stable hyaline cartilage at the operative site. In almost all articles published, patients with misalignment, arthritis, unstable knees, and missing or compromised meniscus, were excluded from the studies due to concerns regarding suitability for the procedures. Finally, there is little agreement on any limitations regarding the size of chondral defects that are appropriate for these procedures. The medical literature suggests that mosaicplasty might be appropriate for lesions ranging from as little as 1.5 cm2 to as large as 16 cm2. Most recent evidence supports the position that the larger the chondral defect, the higher the complication rate and rates of donor site morbidity. Thus, at this time it may be appropriate to limit these procedures to small to moderate lesions, between 1.1 cm2 and 2.5 cm2, until further evidence is available to fully evaluate this issue.
Contraindications for OATS and mosaicplasty of the knee include those patients with a systemic metabolic degenerative disease, arthritis of the knees, flattening of the femoral condyles or severe degenerative changes (greater than 50% joint space narrowing, bone on bone, or erosion to subchondral bone). OATS is not indicated for patients who have undergone partial or total meniscectomy and do not have symptoms or problems with their knee. It is evident that OATS is a viable option for the treatment of symptomatic patients provided rigid inclusion criteria are met. Patients with appropriate indications should expect to do well postoperatively in terms of a predictable reduction in pain and an ability to increase activity levels. Only further study will clarify the long-term results of OATS as well as their role in preventing the progression of secondary osteoarthritis in the involved compartment.
Wang reported the results of 15 patients with 16 knees undergoing osteochondral autograft to repair focal full thickness articular cartilage defects of the knee. Minimum follow-up in this study was two years. Evaluations of patient outcomes were based on functional assessments, which included pain, giving way, locking, recurrent effusion, knee scores, functional scores, and Lysholm scores—statistically significant improvements were achieved in all. The overall results were excellent in seven (43.75%), good in six (37.50%), fair in two (12.50%), and poor in one (6.25%). The latter three had lesions larger than 600 mm2. Radiographs showed mild degenerative changes in seven knees preoperatively and in eight knees postoperatively; however, seven of eight knees showed no progression of degenerative changes postoperatively. No data was reported regarding the donor site.
Osteochondral allograft transplantation is appealing because it provides the ability to resurface larger and deeper defects with mature hyaline articular cartilage and addresses the underlying bone deficit in a single procedure. The appropriate size and surface contour can be matched when the graft is obtained from an appropriately selected organ donor. The biology of articular cartilage makes it ideal for transplantation. It is both aneural and relatively avascular, receiving its nutrition by diffusion from synovial fluid. Furthermore, it is a relative immuno-privileged tissue. The chondrocytes are protected from the host immune surveillance by the surrounding matrix. Therefore, this allows mature living chondrocytes to survive for many years after transplantation without the need for tissue matching or immunosuppression.
Williams and colleagues prospectively followed 19 patients with symptomatic chondral and osteochondral lesions of the knee who were treated with fresh osteochondral allografts between 1999 and 2002. The mean age at the time of surgery was thirty-four years. The mean duration of clinical follow-up was forty-eight months (range twenty-one to sixty-eight months). The mean score (and standard deviation) on the Activities of Daily Living Scale increased from a baseline of 56 +/- 24 to 70 +/- 22 at the time of the final follow-up (P< 0.05). The mean Short Form-36 score increased from a baseline of 51 +/- 23 to 66 +/- 24 at the time of final follow-up (P < 0.005). At a mean follow-up interval of twenty-five months, cartilage-sensitive magnetic resonance imaging demonstrated that the normal articular cartilage thickness was preserved in eight of the eighteen grafts. The authors concluded that fresh osteochondral allografts that were hypothermically stored between seventeen and forty-two days were effective in the short term both structurally and functionally in reconstructing symptomatic chondral and osteochondral lesions of the knee.
The indications for autografts are the small focal lesions that are 1 cm2 to 2.5 cm2 in size. For larger defects, over 2.5 cm2 allografts are preferred. The knee must be stable, not arthritic, and have normal alignment. Current contradictions for the use of allografts include osteoarthritis that has advanced to grade IV, exposed subchondral bone, inflammatory arthritis, obesity, previous infection, multiple lesions, ligamentous instability, severe lower extremity malignancy and significant axial malalignment.
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This service should not be confused with ACT; however, providers may use 29866 when billing ACT. Therefore, the claim should be reviewed when 29866 is billed.
The information contained in this section is for informational purposes only. HCSC makes no representation as to the accuracy of this information. It is not to be used for claims adjudication for HCSC Plans.
Medicare (CMS) does not have a national coverage position. Coverage may be subject to local carrier discretion.
A national coverage position for Medicare may have been developed or changed since this medical policy document was written. See Medicare's National Coverage at <http://www.cms.hhs.gov>.
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|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|
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|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|