Medical Policies - Radiology


Radiostereometric Analysis for Assessment of Orthopedic Implant Position

Number:RAD601.054

Effective Date:10-15-2017

Coverage:

*CAREFULLY CHECK STATE REGULATIONS AND/OR THE MEMBER CONTRACT*

Radiostereometric analysis (RSA) for assessment of orthopedic implant position, wear, migration, soft tissue healing, and/or bone segment grafting or cement migration or loosening, with or without use of implanted markers and/or computer software aided digital views/interpretation, is considered experimental, investigational and/or unproven.

Description:

Roentgen stereophotogrammetry was developed over 40 years ago to localize the position of an object in space using x-rays. Since that time, many investigators have refined the radiostereometric calculations and equivalent computer software. (1) Prior to the initial use with the introduction of computer software to produce 3-dimensional (3D) analysis, standard 2-dimensional (2D) radiographs or x-rays were first studied in 1898 and used for assessment of spinal fusion in 1911. (2, 3) Currently, 2D standard radiographs remain the method to evaluate implant placement. (4)

Background

Radiostereometric analysis (RSA) is intended to detect changes in implant position after orthopedic surgery. The process involves the insertion of spherical tantalum markers (diameter 0.8 to 1.0 mm), the size of a poppy seed, into the bone during surgery. Following the surgical procedure, a pair of simultaneous image x-rays are taken of the surgical site together from two different directions along with a RSA calibration cage. According to the manufacturer, the markers can be precisely located relative to each other and monitored for changes in position that might indicate a problem. (4)

Halifax Biomedical (Halifax Biomedical, Inc., Mabou, Nova Scotia, Canada) provides the Halifax Bead Inserter, the Tantalum Bead Set (16 beads), the Halifax Stereo Radiography Suite (dual low-dose x-ray radiographic imaging system and calibration cage), and RSA services (evaluation and analysis of imaging). (4) The model-based RSA (MBRSA) software is the analytical software package for evaluation of orthopedic implant fixation and bone segment motion. The MBRSA assesses the 3D position calibrated stereo x-rays for measurement and/or relative motion of metal implants, marker beads, and/or bone segments. The analysis by trained physicians assists the provider to make critical patient treatment decisions, such as whether or not to intervene to stabilize an implant when fixation or migration concerns develop or instability has progressed leading to additional fusion procedures. (5) Lately, RSA use in soft tissue (tendons, ligaments, and/or muscle) applications has emerged. (6)

Regulatory Status

The Tantalum Bead Set (Halifax Biomedical, Inc., Mabou, Nova Scotia, Canada) was cleared for marketing by the U.S. Food and Drug Administration (FDA) under the 510(k) process in August 2009. The predicate device was tantalum beads from Biomet, Inc. (Warsaw, Indiana). FDA documentation notes that the bead inserter is a Class I device. A special 510(k) clearance was granted in June 2011 for a bead set sterilized by the manufacturer using gamma radiation. The manufacturer’s indications for use are as follows: “Tantalum bead implants are used as radio-opaque markers and may be implanted into bone or soft tissue. These devices are used to measure movement in implants after surgery with the aid of an x-ray system. Implant surgery associated with the use of radiographic markers may include total joint replacement procedures, soft tissue repair and bone fracture fixation procedures.” (4)

The Halifax SR Suite 1.0 (Halifax Biomedical, Inc., Mabou, Nova Scotia, Canada) was cleared for marketing by the FDA under the 510(k) process in June 2012. According to FDA documentation, the Halifax SR Suite 1.0 has “two regulatory approved x-ray imaging systems; the two systems are integrated through a synchronization switch. The switch allows the two x-ray imaging systems to fire simultaneously, providing a pair of x-ray images from different perspectives to be taken at the exact same time.” The predicate device was the Sedecal Millennium Digital Radiographic System. The two systems used for the same generator. The manufacturer’s labeled indications for use state, “This is a stationary digital x-ray system for general radiography and RSA.” (4)

The MBRSA Software (Halifax Biomedica, Inc., Mabou, Nova Scotia, Canada), a Windows-based software only, was cleared for marketing by the FDA under the 510(k) process in March 2014 as a radiologic system image processing picture archiving and communication system. The predicate device from Medis Medical Imaging Systems (Leiden, The Netherlands), known as the Ortho-CMS (CMS=high resolution film) cleared for marketing as a 510(k) in July 2004 by the FDA. The manufacturer’s indications for use are as follows: “Orthopedic specialists and/or Halifax Biomedical Inc. image processing labs use the MBRSA as a standalone analytical software package for evaluation of orthopedic implant fixation, bone segment motion… when interpreted by trained physicians these measurements may be useful to derive conclusions for patient treatment.” According to the FDA information, the 3D may provide information regarding loosen of implants, wear of implants, and excessive or reduced motion between bones such as in spine instability and spine fusion. (7)

Rationale:

The medical policy was created in July 2014 based on searches of scientific literature in the MedLine database. The most recent search of MedLine was completed through July 29, 2016. The following is a summary of key literature to date.

Radiostereometric analysis (RSA) has been increasingly utilized for the assessment of 3-dimensional (3D) migration patterns of orthopedic implants, particularly total joint prosthesis and spinal fusions. RSA is being considered as an emerging technology, gaining popularity in Europe and promising for implant study advancement recognition in the United States. Orthopedic surgeons use the RSA technology to predict length of use of the implant and to aid in identifying an early warning to implant failure. (8)

The most relevant type of studies evaluating the utility of RSA includes head-to-head comparison between RSA and plain 2-dimensional (2D) standard radiographs. The peer-reviewed published literature reviewed via a MedLine search through May 2014, revealed “expert opinions” to anecdotal use of RSA in orthopedic procedures and assessment of musculoskeletal injuries. The following is a summary of the key literature review.

In 2013, Derbyshire et al. reviewed the current practices of RSA, which included discussion of measurement error, migration data, and the use of RSA as a screening tool. (9) The authors concluded, based on an article reviewed, that there is a need for standardization of the RSA procedure among the increasing number of research groups. Presently, each research group provides their own customized methods of determining study requirements and presentation of the results. Measurement errors, migration direction, mean results, and/or screening for any change(s) lead to different outcomes of the prosthetic/implant studied. The results are only meaningful to that one group and cannot be used in a head-to-head comparison.

ECRI completed a review of RSA in 2013 that concluded, “ECRI’s Institute’s review of one laboratory study published by the manufacturer on its website suggests the Halifax RSA can be used to evaluate bone fusion, but clinical studies of the system’s effectiveness for this indication have not been published. Thus, no published data are available to assess the system’s performance in a clinical setting in light of the claims made by the manufacturer. The only publication featuring the RSA is a simulation study. While these types of studies may be informative, they may not indicate clinical performance.” (4)

The one 2012 simulation study cited by ECRI was from Bostrom, et al. (8) Pairs of x-rays were taken on a L4-L5 model to perform a RSA calculation of the range of motion prior to spinal fusion, directly following surgery (prior to fusion activity), early fusion phase and late fusion phase. Hardware cages and bone grafts were utilized for the model fusion. Tantalum markers were used to identify the changes in motion measurements of six different postures – standing, flexion, extension, axial rotation, lying, and extension in a lying position to another. The most anteriorly placed markers showed the greatest motion between two postures. The greatest difference was between prior to fusion and early fusion as well as early fusion to late fusion.

ECRI updated their review of RSA in 2014. (10) According to ECRI Institute’s Health Devices engineering group, while the usefulness of RSA in a clinical setting seems limited at this time because it does not have the potential to provide an additional advantage over standard radiography, use of RSA in a research setting to measure micromotion of newly developed implants/techniques seems warranted for this emerging technology.

Ongoing and Unpublished Clinical Trials

A search of ClinicalTrials.gov in July 2016 did not identify any ongoing or unpublished trials that would likely influence this review.

Professional Guidelines and Position Statements

There are no professional guidelines and position statements that would likely influence this review.

Summary of Evidence

The use of radiostereometric analysis (RSA) is promising, but there is a lack of large randomized clinical trials comparing RSA to standard radiographs or computed tomography in determining implant placement, migration, bone healing, soft tissue healing that has not been established. As a result, RSA is considered experimental, investigational, and/or unproven as an alternative to current methods to monitor musculoskeletal healing and/or surgical intervention management.

Contract:

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.

Coding:

CODING:

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 vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps.

CPT/HCPCS/ICD-9/ICD-10 Codes

The following codes may be applicable to this Medical policy and may not be all inclusive.

CPT Codes

0347T, 0348T, 0349T, 0350T

HCPCS Codes

None

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

Refer to the ICD-10-CM manual


Medicare Coverage:

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.

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>.

References:

1. Karrhom J, Gill RHS, Valstar E. The history and future of radiostereometric analysis. Clin Orthrop Rel Res. Jul 2006; 448 (4):10-21. PMID 16826090

2. Bottner R, Su EP, Newstor B, et al. Radiostereometric analysis: the hip. Hosp Spec Surg J (HSSJ). 2005; 94-9. Available at <http://www.hss.edu> (accessed on May 30, 2014).

3. Selby MD, Clark SR, Hall DJ, et al. Radiologic assessment of spinal fusion. J Am Acad Orthop Surg. Nov 2012; 20(11):694-703. PMID 23118135

4. ECRI Institute. Radiostereometric Analysis (Halifax Biomedical, Inc.) for Assessing Orthopedic Implant Position; 2013 January. 5 p. (Product Brief).

5. Model-Based RSA Software Receives FDA Clearance – Product Information. Nova Scotia, Canada: Halifax Biomedical (HBI), Inc. (2014 March 12). Available at <http://halifaxbiomedical.com> (accessed on May 30, 2014)

6. Solomon LB, Callary SA. Emerging ideas: soft tissue applications of radiostereometric analysis. Clin Orthop Rel Res. May 2011; 469(5):1215-6. PMID 21104355

7. FDA – 510(k) Summary K133966 – Model-based RSA Software (Halifax Biomedical, Inc.). Food and Drug Administration – Center for Devices and Radiologic Health (2014 March 6). Available at <http://www.fda.gov> (accessed on May 30, 2014).

8. Bostrom MP, Su EP, Wright T. Radiostereometric Analysis (RSA) at HSS. Hosp Spec Surg J (HSSJ). 2006; 1-6. Available at <http://www.hss.edu> (accessed on May 30, 2014).

9. Derbyshire B, Prescott RJ, Porter ML. Notes on the use and interpretation of radiostereometric analysis. ACTA Orthop. Feb 26 2009; 80(1):124-30. PMID 19234894

10. ECRI Institute. Radiostereometric Analysis (Halifax Biomedical, Inc.) for Assessing Orthopedic Implant Position; 2014 June. 7 p. (Product Brief).

Policy History:

DateReason
10/15/2017 Reviewed. No changes.
10/1/2016 Document updated with literature review. Coverage unchanged.
5/15/2015 Reviewed. No changes.
7/1/2014 New medical document. Radiostereometric analysis (RSA) for assessment of orthopedic implant position, wear, migration, soft tissue healing, and/or bone segment grafting or cement migration or loosening, with or without use of implanted markers and/or computer software aided digital views/interpretation, is considered experimental, investigational and/or unproven.

Archived Document(s):

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