| Coverage Policy Manual | |
| Policy #: | 2006006 |
| Category: | Surgery |
| Initiated: | February 2006 |
| Last Review: | September 2023 |
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| Osteochondral Allograft and/or Mosaicplasty for Osteochondral Defects of the Knee | |
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| Description: |
Osteochondral grafts are used to repair full-thickness chondral defects involving a joint. In the case of osteochondral autografts, one or more small osteochondral plugs are harvested from non-weight-bearing sites, usually from 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, decellularized osteochondral allograft plugs, and reduced osteochondral allograft discs are also being evaluated as a treatment of articular cartilage lesions.
Background
Damaged articular cartilage can be associated with pain, loss of function, and disability, and can lead to debilitating osteoarthrosis over time. These manifestations can severely impair an individual’s activities of daily living and quality of life. The vast majority of osteochondral lesions occur in the knee with the talar dome and capitulum being the next most frequent sites. The most common locations of lesions are the medial femoral condyle (69%), followed by the weight-bearing portion of the lateral femoral condyle (15%), the patella (5%), and trochlear fossa (Durur-Subasi, 2015). Talar lesions are reported to be about 4% of osteochondral lesions (Fortin, 2001).
There are 2 main goals of conventional therapy for patients who have significant focal defects of the articular cartilage: symptom relief and articular surface restoration.
First, there are procedures intended primarily to achieve symptomatic relief: debridement (removal of debris and diseased cartilage) and rehabilitation. Second, there are procedures intended to restore the articular surface. Treatments may be targeted to the focal cartilage lesion, and most such treatments induce local bleeding, fibrin clot formation, and resultant fibrocartilage growth. These marrow stimulation procedures include microfracture, abrasion arthroplasty, and drilling, all of which are considered standard therapies
Autologous or allogeneic grafts of osteochondral or chondral tissue have been proposed as treatment alternatives for patients who have clinically significant, symptomatic, focal defects of the articular cartilage. It is hypothesized that the implanted graft’s chondrocytes retain features of hyaline cartilage that are similar in composition and property to the original articulating surface of the joint. If true, the restoration of a hyaline cartilage surface might restore the integrity of the joint surface and promote long-term tissue repair, thereby improving function and delaying or preventing further deterioration.
Both fresh and cryopreserved allogenic osteochondral grafts have been used with some success. However, 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 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 & Nephew), the OATS (Osteochondral Autograft Transfer System; Arthrex), and the COR and COR2 systems (DePuy Mitek). Although mosaicplasty and autologous osteochondral transplantation may use different instrumentation, the underlying mode of repair 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 debridement 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 or autologous osteochondral transplantation may be performed with either an open approach or arthroscopically. Osteochondral autografting has also been investigated as a treatment of unstable osteochondritis dissecans 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 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, the 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.
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 (Johnson and 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 intra-operatively 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 or porated 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.
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 policy No. 1997014.
Autologous osteochondral grafts for the treatment of osteochondral defects of the knee is handled in policy No. 1998142.
Regulatory Status
The U.S. Food and Drug Administration (FDA) regulates human cells and tissues intended for implantation, transplantation, or infusion through the Center for Biologics Evaluation and Research, under Code of Federal Regulation, title 21, parts 1270 and 1271. Osteochondral grafts are included in these regulations.
DeNovo® ET Live Chondral Engineered Tissue Graft (Neocartilage) is marketed by ISTO Technologies outside of the United States. The FDA approved ISTO’s investigational new drug application for Neocartilage in 2006, which allowed ISTO to pursue phase 3 clinical trials of the product in human subjects. However, ISTO’s clinical trial for Neocartilage was terminated due to poor enrollment as of August 31, 2017.
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Policy/ Coverage: |
Effective September 2018
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Osteochondral allografting as a technique to repair large full-thickness chondral defects of the knee caused by acute or repetitive trauma meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in patients who meet the following criteria:
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Osteochondral allografting for all other joints does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
For members with contracts that do not have primary coverage criteria, osteochondral allografting for all other joints is considered investigational. Investigational services are considered specific contract exclusions in most member benefit certificates of coverage.
Treatment of focal articular cartilage lesions with allogeneic minced or particulated cartilage does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
For members with contracts without primary coverage criteria, treatment of focal articular cartilage lesions with allogeneic minced or particulated cartilage is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Effective July 2013 - August 2018
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Osteochondral allografting as a technique to repair large full-thickness chondral defects of the knee caused by acute or repetitive trauma meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in patients who meet the following criteria:
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Osteochondral allografting for all other joints does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
For members with contracts that do not have primary coverage criteria, osteochondral allografting for all other joints is considered investigational. Investigational services are considered specific contract exclusions in most member benefit certificates of coverage.
Treatment of focal articular cartilage lesions with allogeneic minced cartilage does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
For members with contracts without primary coverage criteria, treatment of focal articular cartilage lesions with allogeneic minced cartilage is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Effective July 2011 – June 2013
Osteochondral allografting as a technique to repair large full-thickness chondral defects of the knee caused by acute or repetitive trauma meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in patients who meet the following criteria:
Osteochondral allografting for all other joints does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
For members with contracts that do not have primary coverage criteria, osteochondral allografting for all other joints is considered investigational. Investigational services are considered specific contract exclusions in most member benefit certificates of coverage.
Effective Prior to July 2011
Osteochondral allograft meets primary coverage criteria for effectiveness and is covered as a technique to repair focal chondral defects of the femur in patients who meet the following criteria:
Any other use of osteochondral allograft or mosaicplasty for osteochondral defects of the knee does not meet Primary Coverage Criteria that there be scientific evidence of effectiveness.
For contracts without Primary Coverage Criteria, any other use of osteochondral allograft or mosaicplasty for osteochondral defects of the knee is considered investigational and is not covered. Investigational services are an exclusion in the member benefit certificate.
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| Rationale: |
Gross and colleagues reported on 60 patients who received fresh femoral condylar grafts in young active patients. Kaplan-Meier survivorship showed 95% graft survival at 5 years and 85% at 10 years. If allograft incorporation does occur, the procedure is associated with improved pain, function, range of motion, and a low risk of progressive arthritis (case series, Jamali and associates).
Literature suggests that outcomes are improved with the use of fresh osteochondral allografts but this is complicated by the generalized abbreviated timeline from death until implantation. Chondrocyte survivability is best when fresh but infection screening incubation time may be too long. Human osteochondral allografts stored for approximately 3 weeks undergo decreases in cell viability in the superficial zone whereas matrix and biomechanical characteristics appear preserved.
2008 Update
Gross and associates (Gross AE, 2008) examined histologic features of 35 allograft specimens retrieved at the time of subsequent graft revision or other knee surgery. Graft survival time ranged from 1 to 25 years. Given chondrocyte viability, long-term allograft survival depends on graft stability by rigid fixation of host bone to graft bone.
Little clinical information has been available on the outcome of patients who have been treated with fresh allografts stored for several weeks or more. A study (Williams RJ, 2007) analyzed the clinical outcome and graft morphology in 19 patients with symptomatic chondral and osteochondral lesions of the knee who were treated with fresh allografts between 1999 and 2002. Grafts were obtained commercially, with mean storage time 30 days (17 to 42 days). The mean lesion size was 602 mm(2). Quality of Life was measured using the ADL scale and the Short Form-36. Morphology was evaluated using MRI. At mean follow-up duration of 48 months, the ADL scale increased from 56 to 70 (p<0.05) and the mean Short form-36 score increased from 51 to 66 (p<0.005). At 25 months, cartilage-sensitive MRI showed that normal articular cartilage thickness was preserved in 18 grafts, and allograft cartilage signal properties were similar to normal cartilage in 8 of the 18 grafts. Osseous trabecular incorporation of the allograft was complete or partial in 14 patients and poor in 4 patients. Trabecular incorporation correlated positively with Short Form-36 scores at follow-up. Conclusion: Fresh allografts which had been hypothermically stored for the tested duration were effective in the short term, both structurally and functionally.
2011 Update
A literature search was conducted through June 2011. The identified published literature is summarized below.
Harris and colleagues published a systematic review of combined meniscal allograft transplantation and cartilage repair/restoration in 2010 (Harris, 2011). 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 to 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.
Long-term outcomes with osteochondral allografting have been reported in 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 osteochondritis dissecans of the femoral condyle (Gudas, 2005). 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 and colleagues reported minimum 5-year follow-up on series of 60 patients who received femoral condylar grafts and 65 patients who received tibial plateau grafts for knee defects (Gross, 2005). 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 Hospital for Special Surgery (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 of 10 years) and 97% of patients with a tibial graft (average of 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 score > 70 points. Survival analysis revealed 95% graft survival at 5 years, 80% at 10 years, and 65% at 15 years.
Allografts for Use in Large Defects of the Talus
Use of allografts for large defects of the talus has been reported in small case series. For example, Raikin published results from a series of 15 patients who underwent fresh matched osteochondral allograft transplantation for talar lesions with a volume > 30 cm3 (Nho, 2008). At an average 54 months after surgery (minimum of 2 years), mean visual analog scores (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 (Emmerson, 2007). Patients had undergone an average of 1.8 prior surgeries (range, 1 to 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 to 107 months) 2 of the ankles had failed and undergone revision or fusion. For the remaining 10 patients, the mean Olerud-Molander Ankle Score (OMAS) 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%.
Summary
Evidence is sufficient to consider osteochondral allografting as a technique to repair large (e.g., 10 cm2) full-thickness chondral defects of the knee caused by acute or repetitive trauma. Use of allografts for large defects of the talus has been reported in small case series. Evidence is insufficient to evaluate the effect of osteochondral allografting of the talus, or other joints, on health outcomes. Therefore, osteochondral allografts for joints other than the knee are considered investigational. Recent evidence indicates that osteochondral grafting combined with meniscal allograft results in outcomes similar to either procedure performed alone; therefore the coverage statement has been changed to include combined procedures.
2012 Update
A literature search was conducted through June 2012. There was no new information identified that would prompt a change in the coverage statement. A summary of the relevant information is included below.
In 2011, Berlet et al. reported a prospective study with minimum follow-up of 2 years in 12 patients who had received an osteochondral allograft for talar defects (Berlet, 2011). In another patient, the graft had failed and was not included in the analysis. All patients had failed at least one 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 Short-form (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 (El-Rashidv, 2011). 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.
A search of the online site www.clinicaltrials.gov in May 2012 identified an industry-sponsored Phase IV (post-marketing) trial with Chondrofix® (NCT01410136). The study has an estimated enrollment of 50 patients who may have up to 2 cartilage lesions, each measuring less than 8 cm2, of the femoral condyle or trochlea. The study will follow patients through 60 months and has an estimated completion date of 2017.
2013 Update
A literature search conducted through June 2013 did not reveal any new information on the use of osteochondral allografts for the treatment defects of the knee, that would prompt a change in the coverage statement.
One study on the use of allogeneic minced cartilage was identified. Bleazey and Brigado conducted a retrospective review of 7 patients who were treated with juvenile minced cartilage (DeNovo NT) together with sponge allograft (Bleazey, 2012). 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. A statement was added to the coverage statement addressing the use of allogeneic minced cartilage.
2014 Update
A literature search conducted using the MEDLINE database was conducted through July 2014. There was no new information identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Allogeneic Juvenile Minced Cartilage for Use in the Knee: Evidence on the efficacy of DeNovo NT is limited to case reports and small case series. The largest series, reported in 2013 to 2014, included 13 patients (15 knees) who received particulated juvenile allograft to the patella (Tompkins, 2013). 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.
Allogeneic Juvenile Minced Cartilage for Use in the Ankle: 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 (Coetzee, 2013). 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.(44) 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.
2015 Update
A literature search conducted using the MEDLINE database through July 2015 did not identify any new information that would prompt a change in the coverage statement. The following is a summary of the key identified literature.
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 autologous chondrocyte implantation 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.
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.
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 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.
2017 Update
A literature search conducted through August 2017 did not reveal any new information that would prompt a change in the coverage statement.
2018 Update
A literature search was conducted through August 2018. There was no new information identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Observational Studies
Nielsen et al identified 149 knees in 142 patients who had participated in a sport or recreational activity before a cartilage injury (Nielsen, 2017). Following treatment with one or more osteochondral allografts (mean size, 8.2 cm2 ), 112 (75.2%) patients had returned to the sport. Allograft survival was 91% at 5 years and 89% at 10 years; 14 knees (9.4%) were considered failures.
OSTEOCHONDRAL AUTOGRAFT FOR ARTICULAR CARTILAGE LESIONS OF THE ELBOW
Donor-Site Morbidity
Bexkens et al conducted a meta-analysis of case series that assessed donor-site morbidity after AOT for OCD of the capitulum (Bexkens, 2017). Reviewers included 11 studies with 190 patients (range, 11-33 patients per series); most patients were adolescents. Grafts were harvested from the femoral condyle in 8 studies and from the costal-osteochondral junction in 3 studies. With donor-site morbidity defined as persistent symptoms of at least 1 year or that required intervention, morbidity was reported in 10 (7.8%) of 128 patients from the knee-to-elbow group and 1 (1.6%) of 62 in the rib-to-elbow group. A limitation of this meta-analysis was its incomplete assessment and reporting of outcomes for the donor site in the primary publications.
DECELLULARIZED OSTEOCHONDRAL ALLOGRAFT
Case series have suggested high failure rates for decellularized osteochondral allograft plugs (Chondrofix). A review of records for 32 patients treated by Farr et al identified failure in 23 (72%) patients when failure was defined as structural damage of the graft identified by MRI or arthroscopy, or any reoperation resulting in the removal of the allograft. Johnson et al examined records from an institutional registry of 34 patients who, following discussion of alternative cartilage repair options, chose treatment with a decellularized osteochondral allograft plug (Johnson, 2017). Patient-reported outcomes along with MRI results were recorded at 6 months, 1 year, and 2 years by independent observers. At a mean follow-up of 15.5 months (range, 6-24 months), 10 (29%) patients required revision surgery with removal of the implant. Failure rates were higher for females and larger lesions (hazard ratio, 1.9 per 1 cm2 increase; 95% CI, 1.2 to 3.1; p=0.005).
Section Summary: Decellularized Osteochondral Allograft
The evidence on decellularized osteochondral allograft plugs has reported delamination of the implants and high failure rates.
2019 Update
Annual policy review completed with a literature search using the MEDLINE database through August 2019. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Fresh Osteochondral ALLOgraft for Articular Cartilage Lesions of the Ankle
Diniz et al conducted a systematic review on the use of allografts for 10 foot and ankle indications (Diniz, 2019). A total of 107 studies were identified, 12 of which related to osteochondral lesions of the ankle (N=125 patients). No meta-analyses were conducted. Summary descriptions were not presented separately by lesion size. Eleven of the studies were considered level IV evidence and 1 study was level V evidence. Within these studies, 6 minor complications and 9 major complications were reported, for an overall complication rate of 12%. The authors concluded that osteochondral allografts for lesions of the ankle can be considered in larger defects that are not amenable to bone marrow stimulation or when donor site morbidity is if of concern (grade: C).
Revision of Large (Area >1.5 cm2) or Cystic (Volume >3.0 cm3) Osteochondral Lesions of the Ankle
Gaul et al presented a case series of 19 patients (20 ankles) who received osteochondral allografts for osteochondral lesions of the ankle, 19 of which had prior surgical procedures (drilling, osteotomy, microfracture) (Gaul, 2019). Five of the 20 ankles required further surgery, 3 of which were considered allograft failures. The mean time to failure was 3.5 years. Of the 17 non-failed ankles, median followup was 9.7 years. Mean Olerud-Molander Ankle Score improved significantly following the procedure. Of the 15 patients who answered the followup survey, 14 reported less pain and better function.
Osteochondral Autograft for articular cartilage Lesions of the Elbow
Kirsch et al conducted a systematic review of the literature through July 2016 of case series evaluating return to play after osteochondral autografts for the treatment of osteochondritis dissecans of the capitellum (Kirsch, 2017). Seven case series (N=126) met the inclusion criteria and were rated as moderate quality using the Methodological Index for Non-Randomized Studies. A total of 119 (94%) of the patients undergoing osteochondral autograft transplants successfully returned to competitive sports. The mean time to unrestricted return was 5.6 months (range 3 to 14 months).
Sato et al presented a case series of 72 patients receiving osteochondral autografts for advanced (stage III and IV) osteochondritis dessicans of the humeral capitellum in young athletes, who were followed for at least 3 years (Sato, 2018). The Timmerman and Andrews clinical rating score, which incorporates subjective measures (such as pain, swelling, and activity level) and objective measures (such as flexion and arc of elbow motion) improved significantly from 101 to 190 following the procedure. Seventy of the patients returned to their sport without restrictions by 5.8 months. Subsequent surgeries included additional grafting (n=2), delayed medial ligament reconstruction (n=1), and arthroscopic removal of loose bodies (n=2).
Minced or Particulated Cartilage for Articular Cartilage lesions
Dekker et al conducted a retrospective review of patients receiving partiulated juvenile cartilage allograft transplantation for osteochondral lesions of the talus (N=15) (Dekker, 2018). Twelve of the 15 patients had undergone a prior microfracture procedure and 3 patients received the transplant as a primary procedure. A successful procedure was defined as improvement in pain and no subsequent cartilage procedures, After at least 1 year followup, 9 (60%) cases were considered successful, with 3 patients needing additional cartilage procedures and 3 reporting continued pain. Predictors of failure were larger lesions and male sex.
DiSandis et al reported on a series of 46 patients receiving particulated juvenile cartilage allograft transplantation and autologous bone marrow aspirate concentration for osteochondral lesions of the talus (DiSandis, 2018). Only 24 patients had pre- and post- Foot and Ankle Outcome Scores (FAOS) and 12-item Short Form data. Almost all subscale scores were significantly improved after the procedure; however, MRI showed inhomogeneous repair tissue structure, persistent bone marrow edema, and moderately hyperintense tissue.
2020 Update
Annual policy review completed with a literature search using the MEDLINE database through August 2020. No new literature was identified that would prompt a change in the coverage statement.
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through August 2021. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Zamborsky et al completed a systematic review and network meta-analysis that evaluated the most appropriate surgical interventions for patients with knee articular cartilage defects (Zamborsky, 2020). The authors included a total of 21 articles (from 12 RCTs) in their analysis with a total population of 891 patients. Follow-up varied widely among the included studies, ranging from 12 months to 15 years. Of the surgical interventions evaluated, microfracture was associated with significantly higher failure rates compared to autologous chondrocyte implantation at 10 years of follow-up (relative risk [RR], 0.12; 95% confidence interval [CI]; 0.04 to 0.39). No significant differences in failure rates were seen between microfracture and osteochondral autograft transplantation, matrix-induced autologous chondrocyte implantation, or characterized chondrocyte implantation at 2, 5, and 10 years of follow-up. Osteochondral autograft transplantation was associated with significantly more excellent or good results at > 3 years of follow-up as compared to microfracture, whereas microfracture was associated with significantly poorer results as compared to autologous chondrocyte implantation and matrix-induced autologous chondrocyte implantation. No significant differences between the interventions were noted regarding reintervention, biopsy types, or adverse events. Based on efficacy and safety, autologous chondrocyte implantation was ranked as the best intervention for failure outcome at 10 years of follow-up, followed by osteochondral autograft transplantation, then microfracture. Microfracture was consistently ranked worse than cartilage repair techniques for other outcomes including quality of tissue repair and return-to-activity rates.
Use of autologous osteochondral transplantation is limited by the number of cores that can be taken from the non–weight-bearing part of the talus or ipsilateral knee. Autologous osteochondral transplantation may also be inadequate due to lesion depth or location, such as on the talar shoulder. For osteochondral lesions for which autologous osteochondral transplantation would be inadequate due to lesion size, depth, or location, the use of fresh osteochondral allografts has been investigated. Use of fresh allografts for defects of the talus has been reported mainly in case series and a systematic review of these series (Pereira, 2021). Due to the relatively rare occurrence of this condition, most series have fewer than 20 patients. One RCT was identified that compared autologous osteochondral transplantation with allograft plugs for recurrent cartilage lesions.
Pereira et al published a systematic review including 12 studies (7 retrospective case series and 5 prospective case series) in 191 patients who received a fresh osteochondral allograft for osteochondral lesions of the talus (n=194 ankles; mean lesion size range, 1.21 to 3.8 cm2) (Pereira, 2021). The average patient follow-up was 56.8 months (range, 6 to 240 months). Results revealed that aggregate mean preoperative and postoperative AOFAS scores (n=8 studies) were 49.6 (range, 38-61) preoperatively and 80.4 (range, 72.8-84) postoperatively. All studies reporting both pre- and postoperative AOFAS scores showed significant improvements from the preoperative values (p<0.05). Five studies evaluated the visual analog scale pain score, with significant decreases pre- to postoperatively (p<0.05). Overall, 21.6% of patients required subsequent surgical interventions such as arthroscopic debridement and hardware removal. The overall graft survival rate was 86.6%; 26 graft failures were recorded across the included studies.
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through August 2022. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
A systematic review by Kunze et al focused solely on potential risk factors for failure after osteochondral allograft transplantation of the knee (Kunze, 2022). They included 16 studies consisting of 1401 patients who received an allograft transplant. The pooled prevalence of overall failure was 18.9%. Of the risk factors identified, bipolar chondral defects (odds ratio [OR], 4.20; 95% CI, 1.17 to 15.08; p=.028) and male sex (OR, 2.04; 95% CI, 1.17 to 3.55; p=.012) were significant risk factors for failure after allograft transplant. Older age (mean difference [MD], 5.06 years; 95% CI, 1.44 to 8.70; p=.006) and greater body mass index (MD, 1.75 kg/m2; 95% CI, 0.48 to 3.03; p=.007) at the time of surgery were also significant risk failures for failure. There was no statistical significance to support that concomitant procedures, lesion size, or lesion location were associated with an increased risk of failure.
Merkely et al conducted a systematic review of clinical outcomes after osteochondral allograft transplantation for large chondral defects of the knees (Merkely, 2021). Their review compared patients receiving a primary allograft transplant (n=13) and those receiving allograft transplant as a revision after a failed autologous implant (n=13). All patients demonstrated significant improvement in all functional scores after allograft transplant, and there were no significant differences between groups. Authors concluded that revision of prior failed autologous implant with allograft transplant is a viable treatment option with similar clinical outcomes as primary allograft transplant.
A systematic review of 71 case series or case reports (N=934) by Sayani et al investigated patient-reported functional outcomes, range of motion, and return to sports after treatment (autologous osteochondral transplantation [n=427], fixation [n=141], debridement and microfracture [n=136], and nonsurgical or nonoperative management [n=230]) for osteochondritis dissecans of the capitulum (Sayani, 2021). Subgroup analysis according to treatment type was possible for 30 studies, including 14 studies on autologous osteochondral transplantation. Autologous osteochondral transplant groups demonstrated significant improvements in postoperative functional scores and range of motion, but when standardized, there was no significant differences between treatment types (debridement, fixation, or autograft transplant) in magnitude of outcomes. The overall return to sports was 94% of patients treated surgically. In larger lesions, there was a significantly lower return to sports rate when nonoperative treatment was used compared to surgical intervention (20% vs. 96.3%, respectively; n=114; p<.001). There was no significant difference in return to sports rates between baseball and gymnastics for lesions managed surgically. The highest proportion of return to sports rates was with debridement (100%), followed by autologous osteochondral transplantation (95.9%), and then fixation (83.1%).
A retrospective review by Dawkins et al included 34 patients (36 knees) who received particulated juvenile allograft to the patellofemoral joint (Dawkins, 2021). Return to sport rate among patients who participated in a sport preoperatively was 100% (n=30 patients, 31 knees). After allograft, independent MRI assessment concluded that 67% of patients achieved an overall grade of normal or nearly normal. In terms of defect fill, 78% had majority defect fill. Primary graft failure occurred in 2 cases and 1 patient experienced surgical complication.
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through August 2023. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Feeney published a systematic review and meta-analysis that evaluated autologous osteochondral transplantation in the management of osteochondral lesions of the talus (Feeney, 2022). A total of 23 studies were included, which were assessed to be of poor to average methodological quality using the modified Coleman Methodology Score. The mean area of the lesion, as reported in 13 studies, was 135.5±45.85 mm² (range, 85-249). Across 13 studies, 51% of patients had undergone ankle surgery prior to autologous osteochondral transplantation. More than half of the studies reported preoperative and postoperative VAS scores and American Orthopaedic Foot and Ankle Society (AOFAS) scores. Donor site pain occurred in 9% of cases. Notably, the systematic review did not limit inclusion of studies based on lesion size (i.e., lesions >1.5 cm² were also included) or whether autologous osteochondral transplantation was used as a primary or secondary procedure.
Migliorini et al conducted a systematic review and meta-analysis of 40 studies (1174 procedures) to compare osteochondral allograft versus autologous osteochondral transplantation for osteochondral lesions of the talus (Migliorini, 2022). The included studies (35 retrospective, 4 prospective, and 1 RCT) evaluated the outcomes of allograft and/or autograft osteochondral transplant for management for talar osteochondral defects. At baseline, the length of follow-up, male to female ratio, mean age, body mass index, lesion size, VAS score, and AOFAS score were all comparable between the groups (p>.1). The mean follow-up was 46.5±25 months. The mean lesion size was 1.8±0.8 cm² and 2.6±4.3 cm² in the allograft and autograft groups, respectively. At the last follow-up, the Magnetic Resonance Observation of Cartilage Repair Tissue score (MD, 10.5; p=.04) and AOFAS score (MD, 4.8; p=.04) were better in the autograft group, while the VAS score was similar between the 2 groups (p=.4). At the last follow-up, autografts demonstrated lower rate of revision surgery (OR, 7.2; p<.0001) and failure (OR, 5.1; p<.0001). One main study limitation is the retrospective design of most included studies. Most study authors did not clarify the type of allograft used. Primary and revision surgeries were often mixed, and some authors combined the surgeries with other procedures.
The largest case series, published by Mehta et al, assessed short-term clinical outcomes in 18 patients (8 males, 10 females) with isolated articular cartilage lesions who were treated with marrow stimulation followed by placement of ProChondrix (Mehta, 2022). Mean patient age at surgery was 32.39 years and mean lesion size was 3.86 cm² There were 2 failures requiring reoperation. Study limitations included small sample size and follow-up period. In addition, the procedure was performed by a single surgeon, who also collected, compiled, and analyzed the data. The defects treated in the study were relatively small, focal, contained lesions.
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