Medical Policy: 07.01.65
Original Effective Date: May 2014
Reviewed: August 2020
Revised: August 2020
This policy contains information which is clinical in nature. The policy is not medical advice. The information in this policy is used by Wellmark to make determinations whether medical treatment is covered under the terms of a Wellmark member's health benefit plan. Physicians and other health care providers are responsible for medical advice and treatment. If you have specific health care needs, you should consult an appropriate health care professional. If you would like to request an accessible version of this document, please contact customer service at 800-524-9242.
Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.
Cartilage injuries are described and classified based on the location of injury, size of the injury, and the depth of the injury. The type of surgery necessary largely depends on the aforementioned factors. The procedure is generally an outpatient surgical procedure performed under general anesthesia. Generally performed through arthroscopy (when using an autograft, which is your own body's tissue) or performed as an open surgery for larger lesions requiring an allograft (cartilage taken from a cadaver). Osteochondral deficits may be seen on plain radiograph, but magnetic resonance imaging (MRI) is required for full characterization and a precise diagnosis.
| Grade | Outerbridge |
|---|---|
| 0 | Normal cartilage |
| I | Softening and swelling |
| II | Fragmentation and fissures in area less than 0.5 inch in diameter |
| III | Fragmentation and fissures in area larger than 0.5 inch in diameter |
| IV | Exposed subchondral bone |
Source: Campbell's Operative Orthopaedics, 2007
Osteochondral allografting, also called OATS, osteochondral transfer, or mosaicplasty, involves transplantation of a piece of articular cartilage and attached subchondral bone from a cadaver donor to a damaged region of the articular surface of a joint. The use of donor bone is necessary due to the size of lesion, Osteochondral allografting is recommended for lesions 4cm2-10cm2. The goal of this procedure is to provide viable chondrocytes and supporting bone that will be sufficient to maintain the cartilage matrix and thereby relieve pain and reduce further damage. The procedure is performed through an open approach to the knee.The exact area of cartilage that is missing on the patient's femur is mapped out and harvested as a cylinder of cartilage and bone. This cylinder of donor cartilage is then press fit into the patient's femur, completing the cartilage transplant.
Osteochondral autograft transfer, also called OATS or mosaicplasty, involves harvesting cylinders of cartilage and bone from areas of the knee, from the patient, that do not bear much weight. These cylinders are then press fit into the cartilage lesion on the weightbearing surface of the knee. The donor sites are then backfilled with synthetic plugs or left to heal on their own. During the OATS procedure a single plug is taken from the patient versus several plugs being removed during the mosaicplasty. All plugs will be removed from non-weight bearing areas. Osteochondral autograft transfer is indicated for cartilage lesions from 1.5 cm2 to 4 cm2 that have failed microfracture surgery or abrasive arthroplasty.
These techniques are limited by the amount of donor tissue available in the joint. Donor site morbidity increases as more tissue is harvested. Treatment of small lesions may be performed arthroscopically, while treatment of larger lesions are typically performed through an open arthrotomy.
Minced cartilage repair is considered a second generation technique that does not require in vitro cell expansion and is described as a single-staged minimally invasive procedure. The procedure uses minced pieces of cartilage seeded over a scaffold which allows for even distribution of the chondrocytes to expand within the defect providing structural and mechanical protection. The first clinical application of the minced cartilage technique was the cartilage autograft implantation system (CAIS) developed by DePuy Mitek. A second technology, DeNOVO NT Graft ("Natural Tissue Graft"; Zimmer Inc, Warsaw, is another application for cartilage regeneration using minced donated juvenile cartilage.
Note: The DeNovo® NT Natural Tissue Graft is a tissue based articular cartilage graft that is processed from healthy donors less than 13 years of age and greater than 6 lbs. in weight. Donors are sourced through appropriate Organ and Tissue Procurement Organizations (OTPOs). BioCartilage® (Arthrex)/Arthrex OATS consists of a micronized allogeneic cartilage matrix that is intended to provide a scaffold for microfracture.
ProChondrix® (AlloSource) and Cartiform® (Arthrex) are wafer-thin allografts where the bony portion of the allograft is reduced. The discs contain hyaline cartilage with chondrocytes, growth factors, and extracellular matrix proteins. ProChondrix® is available in dimensions from 7 to 20 mm and is stored fresh for a maximum of 28 days. Cartiform® is cut to the desired size and shape and is stored frozen for a maximum of 2 years. The osteochondral discs are typically inserted after microfracture and secured in place with fibrin glue and/or sutures.
An example of a decellularized allograft plug: Chondrofix®. Chondrofix® is a sterile, decellularized osteochondral allograft (OCA) often in a preshaped cylindrical form, composed of decellularized hyaline cartilage and cancellous bone.
To restore articular surface, standard therapies of marrow stimulation currently in use in the ankle include microfracture, abrasion arthroplasty, and drilling. Microfracture involves debridement of the damaged area and puncturing of the underlying bone to allow bleeding of the bone, stimulating the formation of new joint surface cartilage. For individuals who have primary full-thickness articular cartilage lesions of the ankle less than 1.5 cm2 who receive a fresh osteochondral allograft, there is little evidence. For individuals who have large (area >1.5 cm2) or cystic (volume >3.0 cm3) cartilage lesions of the ankle when autografting would be inadequate who receive a fresh osteochondral allograft, the evidence includes a small number of patients in an RCT, case series, and a systematic review of case series. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. The systematic review found a significant failure rate with osteochondral allografts for talar lesions. Although there is a potential to delay or avoid arthrodesis or total ankle arthroplasty in younger patients, use of an allograft may be detrimental to future treatments. Additional study is needed. An RCT in patients with ankle lesions found similar efficacy for autologous osteochondral transplantation, marrow stimulation, and arthroplasty at 2-year follow-up. Longer-term results were not reported in the RCT. There is a lack of high-quality evidence and paucity in the available results of studies, outside of clinical vetting, that proves osteochondral transplantation results in long-term superior outcomes over marrow stimulation techniques. Limitations of the published evidence, high failure rate, and ongoing concerns for future detriment to the ankle joint are barriers in determining the effects of the technology on health outcomes.
Guidelines from the American College of Rheumatology on management of osteoarthritis (OA) of the hip and knee state that autologous osteochondral plugs (mosaicplasty) is being investigated for repair of focal chondral defects, but that this procedure is “not currently indicated in the treatment of patients with OA” (Altman et al, 2000).
An assessment of mosaicplasty for knee cartilage defects from the National Institute for Health and Clinical Excellence (NICE, 2006) concluded: "Current evidence suggests that there are no major safety concerns associated with mosaicplasty for knee cartilage defects. There is some evidence of short-term efficacy, but data on long-term efficacy are inadequate. In view of the uncertainties about the efficacy of the procedure, it should not be used without special arrangements for consent and audit or research."
In 2010 and 2012 clinical practice guidelines on the diagnosis and treatment of osteochondritis dissecans (OCD), the American Academy of Orthopaedic Surgeons (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.
According to the American Academy of Orthopaedic Surgeons (AAOS), most candidates eligible for articular cartilage restoration are young adults with a single injury or lesion. Older individuals, or those with many lesions in one joint, are less likely to benefit from osteochondral autograft transplantation.
In a Clinical Practice Guideline for the diagnosis and treatment of osteochondritis dissecans, the AAOS states that they unable to recommend for or against a specific cartilage repair technique in symptomatic skeletally immature patients with unsalvageable fragment (AAOS 2010).
An AAOS advisory statement for use of musculoskeletal tissue allografts indicates that the AAOS believes that for appropriate patients musculoskeletal allografts represent a therapeutic alternative. These tissues should be acquired from facilities that demonstrate compliance, use well-accepted banking methodology and follow Food and Drug Administration (FDA) Good Tissue Practices. The AAOS urges all tissue banks to follow rigorous national guidelines and standards and recommends the use of tissue from banks that are accredited by the American Association of Tissue Banks (AAOS 2006).
There is also sufficient evidence to support the use of osteochondral allograft of the knee in patients who are physically active, have failed standard medical and surgical treatments, and are considered too young for total knee arthroplasty.
The American Orthopaedic Foot and Ankle Society supports the use of osteochondral transplantation for the treatment of OLTs that have failed other management, especially for large diameter lesions and cystic lesions. To this end, the AOFAS considers osteochondral transplantation to be a treatment option with demonstrated improved outcomes. This position is based on multiple reports from the peer-reviewed scientific literature.
The Cartilage Autograft Implantation System (Johnson & Johnson) harvests cartilage and disperses chondrocytes on a scaffold in a single-stage treatment. The Reveille Cartilage Processor (Exactech Biologics) has a high-speed blade and sieve to cut autologous cartilage into small particles for implantation. 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 and distributed 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.
A minimally processed osteochondral allograft (Chondrofix; Zimmer) is now available. Chondrofix is composed of decellularized hyaline cartilage and cancellous bone; it 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 autologous osteochondral transplantation or mosaicplasty.
ProChondrix (AlloSource) and Cartiform (Arthrex) are wafer-thin allografts where the bony portion of the allograft is reduced. The discs are laser etched and contain hyaline cartilage with chondrocytes, growth factors, and extracellular matrix proteins. ProChondrix is available in dimensions from 7 to 20 mm and is stored fresh for a maximum of 28 days. Cartiform is cut to the desired size and shape and is stored frozen for a maximum of 2 years. The osteochondral discs are typically inserted after microfracture and secured in place with fibrin glue and/or sutures.
Not applicable.
All of the following criteria must be found in the pre-op notes to determine medical necessity of the procedure.
Osteochondral autografting/allografting for the knee is considered investigational when the above criteria is not met.
Osteochondral autografting for all other joints, including but not limited to: shoulder, hip, elbow, and talar (ankle) joints and any indications other than those listed above, is considered investigational. The success rate and longevity in other joints have not been proven at this time. There is limited evidence in the form of randomized control studies to demonstrate the benefit for treating any other joint problems except those of the articular surfaces of the knee. The greatest requests for use outside the knee exists for the talar joint. The volume of evidence, and quantity of study participants for talar procedures remains insufficient to determine immediate and long-term success.
Treatment of focal articular cartilage lesions with decellularized osteochondral allograft plugs (eg, Chondrofix) is considered investigational.
Treatment of focal articular cartilage lesions with autologous minced cartilage is considered investigational (e.g. CAIS (Cartilage autograft implantation system), The Reveille cartilage processor).
Treatment of focal articular cartilage lesions with allogeneic minced cartilage/biopaste is considered investigational (for example DeNOVO Natural Tissue (NT), BioCartilage® (Arthrex)/Arthrex OATS).
Use of minced articular cartilage (whether synthetic, allograft or autograft) to repair osteochondral defects is considered investigational. Randomized trials that compare the outcomes of minced articular cartilage repair with standard methods have not been published. Clinical studies are needed to establish the safety and outcome benefit of this technique over standard methods of cartilage repair.
Treatment of cartilage lisions using reduced allograft osteochondral disc (e.g., Prochondrix, Cartiform) is considered investigational.
Treatment of cartialage lesions using resorbable synthetic bone filler materials (including but not limited to plugs and granules) to repair osteochondral defects of the knee or ankle is considered investigational. (for example PolyGraft, TruFit BGS Plugs or granules)
Hybrid technique of autologous chondrocyte implantation/osteochondral autograft transfer system (OATS) technique for the treatment of osteochondral defects is considered investigational.
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