Coverage Policy Manual
Policy #: 1998142
Category: Surgery
Initiated: August 1998
Last Review: August 2018
  Osteochondral Autograft Transfer (OATS) and/or Mosaicplasty For Osteochondral Defects of the Knee

Description:
Chondral and osteochondral grafts are used in repair of full-thickness chondral defects involving the joint. In the case of osteochondral autografts, one or more small osteochondral plugs are harvested from non-weight-bearing sites in the knee and press fit into a prepared site in the lesion. Osteochondral allografts are typically used for larger lesions to reduce donor site morbidity. Autologous or allogeneic minced cartilage is also being evaluated as a treatment of articular cartilage lesions.
 
Background
Focal chondral defects of the knee, either 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 symptoms, restore normal biomechanics of the knee joint, and prevent the long-term emergence of osteoarthritis and the necessity for total knee arthroplasty. Various methods of cartilage resurfacing have been investigated including marrow-stimulation techniques such as subchondral drilling, microfracture, and abrasion arthroplasty, all of which are considered standard therapies and all of which attempt to restore the articular surface by inducing the growth of fibrocartilage into the chondral defect. However, fibrocartilage does not share the same biomechanical properties as hyaline cartilage, and thus various strategies for chondral resurfacing with hyaline cartilage have been investigated.
 
Both fresh and cryopreserved allogeneic osteochondral grafts have been used with some success, although cryopreservation decreases the viability of cartilage cells, and fresh allografts may be difficult to obtain and create concerns regarding infectious diseases.  As a result, autologous osteochondral grafts have been investigated as an option to increase the survival rate of the grafted cartilage and to eliminate the risk of disease transmission. Autologous grafts are limited by the small number of donor sites; thus allografts are typically used for larger lesions. In an effort to extend the amount of the available donor tissue, investigators have used multiple, small osteochondral cores harvested from non-weight-bearing sites in the knee for treatment of full-thickness chondral defects. Several systems are available for performing this procedure, the Mosaicplasty System (Smith and Nephew), the Osteochondral Autograft Transfer System (OATS, Arthrex, Inc.), and the COR and COR2 systems (DePuy-Mitek). Although mosaicplasty and OATS may use different instrumentation, the underlying principle is similar; i.e., the 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 6-10 mm in diameter. The grafts are press fit into the lesion in a mosaic-like fashion into the same-sized tunnels. The resultant surface consists of transplanted hyaline articular cartilage and fibrocartilage, which is thought to provide “grouting” between the individual autografts. Mosaicplasty may be performed with either an open approach or arthroscopically. Osteochondral autografting has also been investigated as a treatment of unstable 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 also been used to repair chondral defects of the patella, tibia, and ankle. With osteochondral autografting the harvesting and transplantation can be performed during the same surgical procedure. Technical limitations of osteochondral autografting are difficulty in restoring concave or convex articular surfaces, incongruity of articular surfaces that can alter joint contact pressures, short-term fixation strength and load-bearing capacity, donor site morbidity, and lack of peripheral integration with peripheral chondrocyte death associated with graft harvesting and insertion.
 
Filling defects with minced articular cartilage (autologous or allogeneic), is another single-stage procedure that is being investigated for cartilage repair. The Cartilage Autograft Implantation System (CAIS, Johnson and Johnson, Phase III trial) harvests cartilage and disperses chondrocytes on a scaffold in a single-stage treatment. BioCartilage® (Arthrex) consists of a micronized allogeneic cartilage matrix that is intended to provide a scaffold for microfracture. DeNovo NT Graft (Natural Tissue Graft) and DeNovo® ET Live Chondral Engineered Tissue Graft (Neocartilage) are produced by ISTO Technologies with exclusive distribution rights by Zimmer. DeNovo NT consists of manually minced cartilage tissue pieces obtained from juvenile allograft donor joints. The tissue fragments are mixed 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. As there is no use of chemicals and minimal manipulation, the allograft tissue does not require FDA approval for marketing. DeNovo® ET graft (Neocartilage) uses juvenile allogeneic cartilage cells engineered by ISTO Technologies. The FDA approved ISTO’s Investigational New Drug (IND) application for Neocartilage in 2006, which allowed them to pursue Phase III clinical trials of the product in humans.
 
Allogeneic osteochondral grafts for the treatment of osteochondral defects of the knee is handled in policy No. 2006006.
 
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.
 
Coverage for osteochondral allografts for the treatment of osteochondral  defects of the knee is addressed in policy No. 2006006.
 
 

Policy/
Coverage:
Effective August 2018
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
Osteochondral autograft mosaicplasty, done as a stand alone procedure or in conjunction with repair of the anterior cruciate ligament (OATS procedure), performed open or arthroscopically meets primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes in the following indications:
 
        • to repair focal chondral defects of the femoral condyle of the knee in patients whose BMI is <= 30, with symptomatic, full thickness cartilaginous defect(s) in the medial, lateral, or trochlear area of the femoral condyle or patellar area, which are at least 1 sq. cm but no greater than 3.0 sq. cm in size, which has resulted in physically debilitating/limiting symptoms.  
        • to repair osteochondritis dissecans defects of the knee in patients with symptomatic defects which are at least 1.0 cm2 cm but no greater than 5 cm2 in size.  
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Osteochondral mosaicplasty and osteochondral autograft transfer system (OATS) does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for repair of a cartilage defect for patients with any of the following:
 
        • Body mass index > 30  
        • Defect size less than 1.0 cm2 or greater than 3.0 cm2 for patients with full thickness cartilage defect or defect size less than 1.0 cm2 or greater than 5.0 cm2 for patients with osteochondritis dissecans  
        • Infection at the operative site  
        • Presence of inflammatory diseases  
        • Full thickness cartilage defects located in non-weight bearing areas  
        • History of malignancy in bones, cartilage, fat, or muscle in the treated leg  
        • Moderate to severe osteoarthritis  
        • Uncorrected maltracking/malalignment of the patella  
        • Unstable knee  
 
For contracts without primary coverage criteria, osteochondral mosaicplasty and osteochondral autograft transfer system (OATS) is considered investigational for patients with any of the following:
 
        • Body mass index > 30  
        • Defect size less than 1.0 cm2 or greater than 3.0 cm2 for patients with full thickness cartilage defect or defect size less than 1.0 cm2 or greater than 5.0 cm2 for patients with osteochondritis dissecans  
        • Infection at the operative site  
        • Presence of inflammatory diseases  
        • Full thickness cartilage defects located in non-weight bearing areas  
        • History of malignancy in bones, cartilage, fat, or muscle in the treated leg  
        • Moderate to severe osteoarthritis  
        • Uncorrected maltracking/malalignment of the patella  
        • Unstable knee  
 
Investigational services are an exclusion in the member certificate of coverage.
 
Osteochondral autograft and mosaicplasty do not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for the treatment of cartilage defects of joints other than the knee.
 
For members with contracts without primary coverage criteria, osteochondral autograft and mosaicplasty for the treatment of cartilage defects of joints other than the knee is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Treatment of focal articular cartilage lesions with autologous minced cartilage 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 autologous minced cartilage or particulated cartilage is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Effective Prior to August 2018
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
 
Osteochondral autograft mosaicplasty, done as a stand alone procedure or in conjunction with repair of the anterior cruciate ligament (OATS procedure), performed open or arthroscopically meets primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes in the following indications:
 
    • to repair focal chondral defects of the femoral condyle of the knee in patients whose BMI is <= 30, with symptomatic, full thickness cartilaginous defect(s) in the medial, lateral, or trochlear area of the femoral condyle or patellar area, which are at least 1 sq. cm but no greater than 3.0 sq. cm in size, which has resulted in physically debilitating/limiting symptoms.  
    • to repair osteochondritis dissecans defects of the knee in patients with symptomatic defects which are at least 1.0 cm2 cm but no greater than 5 cm2 in size.  
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Osteochondral mosaicplasty and osteochondral autograft transfer system (OATS) does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for repair of a cartilage defect for patients with any of the following:
    • Body mass index > 30  
    • Defect size less than 1.0 cm2 or greater than 3.0 cm2 for patients with full thickness cartilage defect or defect size less than 1.0 cm2 or greater than 5.0 cm2 for patients with osteochondritis dissecans  
    • Infection at the operative site  
    • Presence of inflammatory diseases  
    • Full thickness cartilage defects located in non-weight bearing areas  
    • History of malignancy in bones, cartilage, fat, or muscle in the treated leg  
    • Moderate to severe osteoarthritis  
    • Uncorrected maltracking/malalignment of the patella  
    • Unstable knee  
 
For contracts without primary coverage criteria, osteochondral mosaicplasty and osteochondral autograft transfer system (OATS) is considered investigational for patients with any of the following:
    • Body mass index > 30  
    • Defect size less than 1.0 cm2 or greater than 3.0 cm2 for patients with full thickness cartilage defect or defect size less than 1.0 cm2 or greater than 5.0 cm2 for patients with osteochondritis dissecans  
    • Infection at the operative site  
    • Presence of inflammatory diseases  
    • Full thickness cartilage defects located in non-weight bearing areas  
    • History of malignancy in bones, cartilage, fat, or muscle in the treated leg  
    • Moderate to severe osteoarthritis  
    • Uncorrected maltracking/malalignment of the patella  
    • Unstable knee  
 
Investigational services are an exclusion in the member certificate of coverage.
 
Osteochondral autograft and mosaicplasty do not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for the treatment of cartilage defects of joints other than the knee.
 
For members with contracts without primary coverage criteria, osteochondral autograft and mosaicplasty for the treatment of cartilage defects of joints other than the knee is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Treatment of focal articular cartilage lesions with autologous 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 autologous minced cartilage is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Effective July 2011 – June 2013
Osteochondral autograft mosaicplasty, done as a stand alone procedure or in conjunction with repair of the anterior cruciate ligament (OATS procedure), performed open or arthroscopically meets primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes in the following indications:
    • to repair focal chondral defects of the femoral condyle of the knee in patients whose BMI is <= 30, with symptomatic, full thickness cartilaginous defect(s) in the medial, lateral, trochlear or patellar area of the femoral condyle which are at least 1 sq. cm but no greater than 3.0 sq. cm in size, which has resulted in physically debilitating/limiting symptoms.
    • to repair osteochondritis dissecans defects of the knee in patients with symptomatic defects which are at least 1.0 cm2 cm but no greater than 5 cm2 in size.
 
Osteochondral mosaicplasty and osteochondral autograft transfer system (OATS) does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for repair of a cartilage defect for patients with any of the following:
    • Body mass index > 30
    • Defect size less than 1.0 cm2 or greater than 3.0 cm2 for patients with full thickness cartilage defect or defect size less than 1.0 cm2 or greater than 5.0 cm2 for patients with osteochondritis dissecans
    • Infection at the operative site
    • Presence of inflammatory diseases
    • Full thickness cartilage defects located in non-weight bearing areas
    • History of malignancy in bones, cartilage, fat, or muscle in the treated leg
    • Moderate to severe osteoarthritis
    • Uncorrected maltracking/malalignment of the patella
    • Unstable knee
 
For contracts without primary coverage criteria, osteochondral mosaicplasty and osteochondral autograft transfer system (OATS) is considered investigational for patients with any of the following:
    • Body mass index > 30
    • Defect size less than 1.0 cm2 or greater than 3.0 cm2 for patients with full thickness cartilage defect or defect size less than 1.0 cm2 or greater than 5.0 cm2 for patients with osteochondritis dissecans
    • Infection at the operative site
    • Presence of inflammatory diseases
    • Full thickness cartilage defects located in non-weight bearing areas
    • History of malignancy in bones, cartilage, fat, or muscle in the treated leg
    • Moderate to severe osteoarthritis
    • Uncorrected maltracking/malalignment of the patella
    • Unstable knee
Investigational services are an exclusion in the member certificate of coverage.
 
Osteochondral autograft and mosaicplasty do not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for the treatment of cartilage defects of joints other than the knee.
 
For members with contracts without primary coverage criteria, osteochondral autograft and mosaicplasty for the treatment of cartilage defects of joints other than the knee is considered investigational.  Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Effective prior to July 2011
Osteochondral autograft mosaicplasty, done as a stand alone procedure or in conjunction with repair of the anterior cruciate ligament (OATS procedure), performed open or arthroscopically meets primary coverage criteria for effectiveness and is covered
    • to repair focal chondral defects of the femur in patients whose BMI is <= 30, with symptomatic, full thickness cartilaginous defect(s) in the medial, lateral, trochlear or patellar area of the femoral condyle which are at least 1 sq. cm but no greater than 3.0 sq. cm in size, which has resulted in physically debilitating/limiting symptoms.
    • to repair osteochondritis dissecans defects of the femur in patients with symptomatic defects which are at least 1.0 cm2 cm but no greater than 5 cm2 in size.
 
Osteochondral mosaicplasty and osteochondral autograft transfer system (OAT) is not covered for repair of a cartilage defect for patients with any of the following:
    • Body mass index > 30
    • Defect size less than 1.0 cm2 or greater than 3.0 cm2 for patients with full thickness cartilage defect or defect size less than 1.0 cm2 or greater than 5.0 cm2 for patients with osteochondritis dissecans
    • Infection at the operative site
    • Presence of inflammatory diseases
    • Full thickness cartilage defects located in non-weight bearing areas
    • History of malignancy in bones, cartilage, fat, or muscle in the treated leg
    • Moderate to severe osteoarthritis
    • Uncorrected maltracking/malalignment of the patella
    • Unstable knee
for members covered based on benefit certificate primary coverage criteria lack of evidence of effectiveness.
 
For contracts without primary coverage criteria, osteochondral mosaicplasty and osteochondral autograft transfer system (OATS) for patients with any of the following:
    • Body mass index > 30
    • Defect size less than 1.0 cm2 or greater than 3.0 cm2 for patients with full thickness cartilage defect or defect size less than 1.0 cm2 or greater than 5.0 cm2 for patients with osteochondritis dissecans
    • Infection at the operative site
    • Presence of inflammatory diseases
    • Full thickness cartilage defects located in non-weight bearing areas
    • History of malignancy in bones, cartilage, fat, or muscle in the treated leg
    • Moderate to severe osteoarthritis
    • Uncorrected maltracking/malalignment of the patella
    • Unstable knee
is considered investigational.  Investigational services are an exclusion in the member certificate of coverage.
 
Mosaicplasty is not covered for treatment of cartilage defects of the shoulder, elbow, or ankle because of lack of evidence of effectiveness, and is considered investigational.

Rationale:
The treatment of articular cartilage defects is a spectrum of treatment modalities which extends from physical modalities (e.g., non-weightbearing to physical therapy exercises), to mechanical debridement, to marrow stimulation procedures (microfracture, drilling), to replacement of the osteochondral surface (mosaicplasty, osteochondral autograft transfer), and to implantation of autologous cartilage cells.  Most papers which discuss treatment of full thickness cartilage defects acknowledge that limited information exists about the treatment of this condition.  This policy addresses procedures which use autologous chondral and bone tissue plugs to replace injured cartilage tissue. (Implantation of autologous cartilage cells is addressed in the policy on Autologous Chondrocyte Implantation, and replacement of injured cartilage with allogeneic tissue is addressed in the policy entitled Osteochondral Allograft for Osteochondral Defects.)
 
Which chondral lesions, and which treatment have been discussed in multiple articles.  For instance, in one review, the authors stated that small lesions (< 1.5 cm2) found during repair of ACL tears did not require treatment (Shelbourne, 2003).  Most of the information available on the safety and effectiveness of mosaicplasty and OAT procedures comes from small case series which the authors have designated level 4 evidence for effectiveness.  A rare study has follow-up beyond 3 years (Marcacci, 2007; Barber, 2006; Gudas, 2006; Chow, 2004).  
 
There are no randomized trials comparing the mosaicplasty or OAT procedures to physical therapy. The Shelbourne study, a case control study, did report on the outcome of untreated traumatic articular cartilage defects found at the time of anterior cruciate ligament repair.  Out of 2770 ACL reconstructions, 125 were done in patients who had an articular cartilage defect grade 3 or 4 but with menisci intact.  No specific postoperative treatment was directed at the cartilage defect.  The mean defect size was 1.7 cm2 (range 0.5 to 6.5 cm2).  Patients were evaluated at one, two, and 5 years after surgery and every 5 years thereafter with the use of International Knee Documentation Committee criteria, modified Noyes subjective questionnaire, and radiographs, and compared to a control group of patients matched on the basis of sex, age, and no chondral defect or meniscal tear at time of ACL repair.  The authors found subjective scores that were significantly higher in the control group, but the average for the chondral defect group showed a low rate of symptoms.  There was no significant correlation between the larger defect size and lower subjective scores, and the distribution of IKDC radiographic ratings was not significantly different between the groups.  A concern of this study was the dropout rate for those who were studied objectively.
 
There is only one randomized controlled trial which compared OAT and microfracture for treatment of symptomatic articular cartilage damage of the knee.  Of the 60 young athletes enrolled, 57 were available for follow-up (28 in the OAT group, and 29 who had microfracture).  Symptoms were present for a mean of 21 months, and follow-up was 36 to 38 months (follow-up consisted of ICRS scores, MRI, standard knee radiograph, and clinical assessment.  An independent observer performed the follow-up examinations.  Arthroscopy with biopsy was done at 12 months, and the results were evaluated by an independent pathologist.  96% of the patients receiving OAT, and 52% of patients receiving microfracture had excellent or good results (Gudas, 2005, 2006).  The study had a small number of patients and relatively brief follow-up and this paper was published in two separate journals in two different years, with slightly different authors and titles but identical patient population.
 
There are two studies which have compared mosaicplasty with autologous chondrocyte implantation.  An Italian study compared mosaicplasty with autologous chondrocyte implantation for chondral defects of the knee; treatment was scheduled 6 months following debridement (Dozin, 2005). Of 44 patients enrolled, nearly one third (14 patients) were considered to be clinically cured following simple debridement and required no further treatment. Another 16% were lost to follow-up. Of the remaining patients treated with mosaicplasty, 88% showed complete recovery compared with 68% of those treated with autologous chondrocyte implantation (p = 0.09). These results are limited by the high number of dropouts and the lack of power in the remaining treatment groups. In addition, patients with a lesion dimension of 1-2 cm were included; the average lesion size was less than 2 cm. The high rate of spontaneous improvement following simple debridement raises questions about these inclusion criteria and the appropriateness of additional surgical intervention in this population.
 
A second study, with only a 2-year follow-up which compared biopsy results of the cartilage as well as clinical response in of 40 patients randomly assigned to the mosaicplasty and autologous chondrocyte implantation procedures.  There was slower clinical response in the ACI group, but both groups showed improvement in symptoms.  Tissue biopsies showed the ACI treated patients were primarily filled with fibrocartilage, whereas the osteochondral cylinder transplants retained their hyaline character, although there was a persistent interface between the transplant and the surrounding original cartilage (Horas, 2003).
 
The case series (level of evidence 4) with more than brief follow-up which report improved outcomes from mosaicplasty or OAT procedures essentially limited patients to those with full thickness cartilage defects which were no more than 3 cm2 in size (Marcacci, 2007; Barber, 2006; Marcacci 2005; Chow, 2004; Jakob, 2002.)
 
The effect on joint function following removal of osteochondral donor plugs from the non-weightbearing lateral femoral condyle has been studied in a small number of young athletes who had donor plugs removed to treat cartilaginous lesions of the elbow joint.  At a mean follow-up of 26 months, MRI studies, Lysholm knee score, and International Cartilage Repair Society evaluation of the knee were performed.  MRI imaging showed 50% to 100% fill in 6 of 9 patients, and the Lysholm score and IKDC evaluation graded excellent and normal on all patients.  
 
There are no systematic reviews of either the mosaicplasty or OAT procedures.  The National Health Service National Institute for Health and Clinical Excellence (NICE) published a “Procedure Guidance” on mosaicplasty for knee cartilage defects in March 2006, and concluded: Current evidence 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…Clinicians wishing to undertake mosaicplasty for knee cartilage defects should ensure that patients understand the uncertainty about the procedure’s efficacy and the options for alternative treatments.  They should provide them with clear written information…”
 
Hayes, Inc published a technology assessment in June 2005 along with an updated search in June 2007, and concluded that evidence is lacking regarding the efficacy of mosaicplasty as treatment for articular cartilage defects of the knee or for treatment of any other articular cartilage defect because of limited or unavailable evidence.
 
Similar, but less robust level 4 evidence of effectiveness is available for evaluation of mosaicplasty for treatment of osteochondritis dissecans of the knee (Miura 2007; Miniaci, 2007).  These case studies show improved outcomes, but more evidence of effectiveness is needed.
 
There is even less peer-reviewed evidence of effectiveness of mosaicplasty in joints other than the knee, with most of the information provided directed to damage to the talus (Kreuz, 2006; Lee, 2003; Al-Shaikh, 2002; Gautier, 2002).  Small case series have been published on treatment of elbow (capitellar) osteochondritis dissecans (Wahegaonkar, 2007); and shoulder (Scheibel, 2004).  For each of these joints, the donor site is from the non-weight bearing surface of the knee.  Because of a lack of evidence, mosaicplasty of the talus, elbow, or shoulder is not covered.
 
2011 Update
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.
 
Joints Other Than the Knee
 
Elbow
Iwasaki et al. reported minimum 2-year follow-up after osteochondral mosaicplasty for osteochondritis dissecans of the elbow in 19 teenage athletes (mean age of 14 years) in Japan (Iwasaki, 2009).  Preoperative symptoms consisted of pain with sports activities (n=19) patients, limited range of motion (n=5), and elbow catching (n=3). Indications for surgery included failure of more than 6 months of conservative treatment or evidence on plain radiographs and magnetic resonance imaging of unstable lesions, such as displaced (n = 7) or detached (n = 12) fragments. The mean defect size was 1.5 cm2 (range, 0.5 to 3.0 cm2). Two independent observers assessed clinical findings at a mean of 45 months (range, 24–87 months); the radiologist was blinded to the clinical outcomes. Graft incorporation was observed in all patients, with nearly normal surface integrity of the articular cartilage and underlying bone in 18 patients. Eighteen of the 19 patients were classified with good to excellent results and were free from elbow pain. One patient was classified as fair with mild pain. Seventeen of the 19 patients, including all pitchers, returned to a competitive level of baseball. Mild donor site pain in the knee was reported in one patient.
 
Shoulder
A European study reported 9-year follow-up after osteochondral autografting for cartilage defects of the shoulder in 7 patients (Kircher, 2009). One additional patient was reported to have had donor site morbidity at the knee and chose not to return for follow-up. All of the plugs showed full integration with the surrounding bone and 6 of 7 patients showed a congruent joint surface. The Constant score improved from 76 preoperatively to 90 points at 33 months, and remained at 91 points at the 9-year follow-up. Subscores for pain and activities of daily living showed significant improvement at 33-month follow-up, with a very slight non-significant decline at 9-year follow-up. None of the patients required additional shoulder surgery.
 
Talus
Zengerink et al. published a systematic review of treatment of osteochondral lesions of the talus in 2010 (Zengerink, 2010). Fifty-one nonrandomized and 1 randomized trial were included in the review. Success rates averaged 85% for bone marrow stimulation, 87% for osteochondral autografting, and 76% for ACI. Because of the high cost of ACI and the knee morbidity seen with osteochondral autografting, the authors concluded that bone marrow stimulation is the treatment of choice for primary osteochondral talar lesions. A 2009 report examined the association between defect size and outcomes following marrow stimulation techniques in 120 ankles (Choi, 2009). Eight ankles subsequently underwent osteochondral transplantation and 22 ankles were considered clinical failures (American Orthopaedic Foot and Ankle Society [AOFAS] Ankle-Hindfoot score <80). Linear regression suggested a cutoff defect size of 1.5 cm2 for marrow stimulation techniques, with an 80% failure rate compared to a 10.5% failure rate for ankles with a defect size < 1.5 cm2. Three of 58 ankles (5.2%) with a defect area < 1 cm2 showed clinical failure, while 7 of 37 ankles (18.9%) with a defect area between 1.0 and 1.5 cm2 had failed.
 
In 2006, Kreuz et al. reported outcomes from a series of 35 patients who underwent osteochondral grafting from the ipsilateral talar articular facet (with or without osteotomy) following failed bone marrow stimulation (Kreuz, 2006). Six of the patients had previously undergone osteochondral or cancellous bone grafting of the defect area. The mean lesion size was 6.3 mm. At a mean follow-up of 49 months (range 33 to 77 months), the AOFAS Ankle-Hindfoot score had improved from 54.5 (range 47 – 60) to 89.9 points (range 80-100).
 
In 2011, Imhoff and colleagues reported retrospective review with long-term outcomes following osteochondral autografts of the talus in 28 consecutive patients (Imhoff, 2011). The osteochondral grafts were harvested from the femoral condyles and malleolar osteotomies were performed whenever the osteochondral defect could not be reached from the anterior incision. One patient was lost to follow-up and 2 patients had a revision operation on the ankle. For 16 of the remaining 25 patients (64%) the autograft was the first line of treatment and in 9 patients (36%) it was a second surgical intervention. Between baseline and average 7 years follow-up (range, 53-124 months), the AOFAS score increased from 50 to 78 points, the Tegner score increased from 3.1 to 3.7, and the VAS for pain decreased from 7.8 to 1.5. Patients who had transplant as a second procedure had significantly worse AOFAS (62 vs. 87) and Tegner scores (2.0 vs. 4.6) and higher VAS scores (3 vs. 0.6).
 
Summary
For osteochondral autografting, only 2 relatively small randomized controlled trials from Europe have demonstrated improved clinical outcomes with osteochondral autografting of the knee when compared with microfracture. Data regarding the long-term viability of the transplanted osteochondral hyaline cartilage is also limited. However, controlled studies demonstrate similar benefit to other cartilage resurfacing procedures in appropriately selected patients, and a number of uncontrolled studies indicate that osteochondral autografts can improve symptoms in some patients with lesions of the femoral condyle who have failed prior surgical treatment. These patients have limited options. Therefore, based on expert opinion received and additional literature reviewed, it is concluded that osteochondral autografts may be considered an option for symptomatic full-thickness chondral lesions of the femoral condyle or trochlea caused by acute or repetitive trauma, in patients who have had an inadequate response to a prior arthroscopic or other surgical repair procedure. Recent evidence indicates that osteochondral grafting combined with meniscal allograft results in outcomes similar to either procedure performed alone.
 
Evidence is currently insufficient to evaluate the efficacy of osteochondral autografts for joints other than the knee, or to evaluate the efficacy of osteochondral autografts in comparison with other surgical repair procedures as a primary treatment of small lesions. Questions also remain about the natural history of asymptomatic lesions found incidentally during other surgical procedures. Controlled trials with longer follow-up are needed to demonstrate that use of osteochondral autografts as a primary treatment results in improved clinical outcomes in comparison with traditional marrow-stimulating procedures.
 
2012 Update
This policy is being updated with a literature review through June 2012.  There was no new information identified that would prompt a change in the coverage statement. The following is a summary of the relevant publications identified in the search.
 
Osteochondral Autograft for Focal Articular Cartilage Lesions of the Knee
Ollat et al. reported a retrospective multicentrer study from the French Society of Arthroscopy that included 142 patients and a mean follow-up of 8 years (Ollat, 2011). (The authors comment that this technique has been used extensively in France due to restrictive legislation on restoration techniques, including chondrocyte transfer.) The mean size of the lesion was 2.29 cm2, and the most common etiologies were osteochondral fractures (n=79) and OCD (n=61). The mean number of plugs was 4 (range, 1-14). Postoperative complications occurred in 19 patients (13%). Most patients (81.8%) were satisfied or very satisfied with the functional outcomes. There was a significant improvement in the ICRS, International Knee Documentation Committee (IKDC) function, and Hughston scores at follow-up. The factors for a good prognosis were found to be: male gender, location of the defect in the medial femoral condyle, OCD, deep, small defects, and a short interval before surgery. Obesity, smoking, work-related accidents, the level of sports practiced, the percentage of coverage of the defect, the number of plugs, and associated lesions did not have a statistically significant effect on the functional results in the final follow-up.
 
Osteochondral Autografts for Joints other than the Knee
Hangody et al. reported 2- to 7-year follow-up in 36 consecutive patients treated with osteochondral autografting for OCD of the talus (Hangody, 2001). Most of the patients had previous surgical interventions and presented with Stage III or IV lesions (completely detached or displaced fragment). The average size of the defect was 1 cm, and the average number of grafts per patients was 3 (range, 1-6). At mean follow-up of 4.2 years, ankle function measured by the Hannover scoring system showed good to excellent results in 34 cases (94%). Examination by radiograph, computed tomography (CT), and magnetic resonance imaging (MRI) showed incorporation into the recipient bed and congruency of the articular surface.
 
In 2011, Liu et al. reported osteochondral autografting in 16 patients for acute osteochondral fractures of the talar dome associated with an ankle fracture (Liu, 2011). Ankle radiographs were taken at 2, 6, and 12 weeks postoperatively and every 3 months after fracture healing. MRI was performed after 12 months and at the latest follow-up. At an average 36-month follow-up (range, 21–48 months), the AOFAS score was 95.4 (range, 86-100). At the latest follow-up, there was no radiographic evidence of post-traumatic arthritis, and MRI showed bony integration and articular congruity of the talar dome in 93.7% of the osteochondral grafts.
 
2013 Update
 
Osteochondral Autografts in Comparison with Microfracture
Three randomized controlled trials from the same group of investigators and 1 retrospective comparative trial have been identified that compared outcomes following osteochondral autografting or microfracture.
 
Gudas et al. reported a well-controlled and blinded comparison of arthroscopic OAT versus microfracture for lesions of the femoral condyle (1–4 cm2) in 60 athletes between 15 and 40 years of age (mean, 24.3 years) (Gudas, 2005). Follow-up on 95% of the athletes for up to 3 years following surgery showed that more athletes returned to sports activities (mean, 6.5 months) following OAT (93% vs. 52%), and fewer required revision (1of 28 vs. 9 of 29 – both respectively). Overall, 96% of patients treated by OAT had an excellent or good result compared with 52% treated by microfracture. At 1 year follow-up, scores on the International Cartilage Repair Society (ICRS) cartilage grading system improved from a baseline of 51 to 86 in the OAT group and 76 in the microfracture group. At 3-year follow-up, scores from HSS questionnaires improved from a baseline of 77 to 91 in the OAT group and 81 in the microfracture group. No donor-site morbidity was observed. Blinded arthroscopic and histological assessment in a subset of patients showed hyaline cartilage of normal appearance following transplantation, whereas microfracture was frequently observed to result in surface fibrillation and soft fibroelastic tissue. At 10-year follow-up there were 4 failures (14%) in the OAT group and 11 failures (38%) in the microfracture group (Gudas, 2012). The Tegner scores decreased in both groups over time, but remained significantly better following OAT than microfracture. In the subgroup of patients who were less than 25 years of age at the time of surgery, 15 of 20 patients (75%) in the OAT group and 8 of 22 patients (37%) in the microfracture group maintained the same level of activity (competitive athletes or frequently sporting) as before the injury. The level of sporting activity was reported to decrease in older patients because of age or other reasons not related to their knee.
 
Another report by Gudas and colleagues was a comparison of mosaicplasty versus microfracture or debridement. One hundred and two patients with lesions associated with anterior cruciate ligament (ACL) injury were randomized to one of the three procedures in association with ACL repair (Gudas, 2013). A matched control group of 34 patients with ACL injury but no articular cartilage lesion was included for comparison. The postoperative rehabilitation protocol was the same for the 3 treatment groups. At a mean 36.1 month follow-up, patients were evaluated with the International Knee Documentation Committee (IKDC) score, Tegner activity score, and clinical assessment. All groups showed a significant improvement in the IKDC score compared to before surgery. Patients without cartilage lesions had IKDC subjective scores that were significantly better than patients with cartilage lesions. For the 3 groups of patients with cartilage lesions, the mosaicplasty group’s IKDC subjective knee evaluation was significantly better than the microfracture or debridement groups, although the differences between the groups were modest. Tegner activity scores were similar for the mosaicplasty and microfracture groups (7.1 and 6.9, respectively), and slightly lower for the debridement group (6.2).
 
Gudas and colleagues also published a randomized trial of osteochondral transplantation (n=25) versus microfracture (n=25) in children 12 to 18 years of age (mean of 14.3 years) (Gudas, 2009). Only children with grade 3 or 4 osteochondritis dissecans (OCD) defects of the femoral condyles were included in the study. The OCD defects were between 2 and 4 cm2 in area, and the mean duration of symptoms was 24 months. Follow-up was obtained in 94% of patients. After 1 year, the proportion of excellent to good outcomes was similar for the 2 groups (92% for osteochondral transplantation vs. 86% for microfracture). However, after a mean 4.2 years of follow-up (range 3 to 6 years), the microfracture group showed 9 failures (41% of 22). In comparison, there were no failures in the osteochondral transplantation group, and good to excellent outcomes were obtained in 83% of the children. Magnetic resonance imaging (MRI) at a mean 18 months after the operation showed no evidence of graft loosening or migration with excellent or good repair in 19 of 21 children (91%). In comparison, blinded evaluation showed excellent or good repair in 10 of 18 children (56%) after microfracture.
 
Krych et al. reported a retrospective comparison of 96 patients treated with either mosaicplasty or microfracture for articular cartilage defects of the knee (Gudas, 2009). Outcomes were measured annually at 1, 2, 3, and 5 years. At the latest follow-up, there was no significant difference between the 2 groups in the SF-36 physical component, the Knee Outcome Survey activities of daily living or IKDC scores. The mosaicplasty group showed a greater improvement in the Marx Activity Rating Scale at the 2, 3, and 5 year follow-up.
 
Other joints
A prospective, uncontrolled study of 32 patients who underwent open osteochondral autografting of the talus for osteochondritis dissecans was reported in 2012 (Emre, 2012). The osteochondral grafts were harvested from the ipsilateral knee and placed in the talus after medial maleolar osteotomy. At baseline, the average AOFAS score was 59.1. At a mean 16.8 months follow-up (range, 12 to 24 months), the AOFAS score had improved to 87.9. All patients showed an improvement of at least 20 points. The Lysholm score, used to assess donor site morbidity, was 88 points at 6 weeks postoperatively and 98 points at 6 months. Two patients had persistent knee pain at the last follow-up.
 
Autologous Minced Cartilage
In 2011, Cole et al. reported a multicenter trial with 29 patients (out of 582 screened) randomized in a 1:2 ratio to microfracture or Cartilage Autograft Implantation System (CAIS) (Cole, 2011). In the single-stage CAIS procedure, autologous hyaline cartilage was harvested, minced, affixed on a synthetic absorbable scaffold, and then fixed on the lesion site with absorbable staples. At baseline, there were no significant differences between groups in the duration of symptoms, International Cartilage Repair Society (ICRS) grade, and area and depth of the chondral defect. There was a difference in the gender and work status of the 2 groups. At 3 weeks and 6 months follow-up, there were no significant differences in outcomes between the 2 groups, but at later time points there were differences reported. The IKDC score was significantly higher in the CAIS group compared to the microfracture group at both 12 (73.9 vs. 57.8) and 24 (83.0 vs. 59.5) months. All subdomains of the KOOS (Symptoms and Stiffness, Pain, Activities of Daily Living, Sports and Recreation, Knee-related Quality of Life) were significantly increased at 24 months in the CAIS group compared with microfracture patients. Qualitative analysis of magnetic resonance imaging (MRI) at 3 weeks, and 6, 12, and 24 months showed no differences in fill of the graft bed, tissue integration, or presence of subchondral cysts. Adverse events were similar for the 2 groups.
 
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.
 
In 2014, Astur et al reported a prospective study of 33 patients with symptomatic patellar lesions (1-2.5 cm in diameter) treated with osteochondral autografting (Astur, 2014). Patients were excluded if they had a patellar tilt abnormality, a patella alta, or a patella baja, a greater than 15-mm distance of the tibial tubercle and trochlear groove, ACL injury, or a meniscal tear. A single osteochondral plug was used in 85% of cases. At a minimum 2-year follow-up (range, 24-54 months), all patients were reported to have significant improvement in functional scores, as measured by the Lysholm, Kujala, and Fulkerson scores and the SF-36 life quality score. MRI at 2 years showed full bone-plug integration into the patella.
 
Solheim et al reported 5- to 9-year (n=69) and 10- to 14-year (n=73) follow-up from patients treated for articular cartilage defects of the femoral condyle, patella, or trochlea (Solheim, 2010; Solheim 2013). Exclusion criteria were joint space narrowing, axial malpositioning, ligament instabilities, or inability to follow the rehabilitation protocol. A median of 4 grafts (range, 1-11) were used to treat lesions that ranged in size from 1 to 5 cm2. The Lysholm score improved from 49 at baseline to 72 at mid-term follow-up and remained at 72 at the 10- to 14-year follow-up. Visual analog scale (VAS) score for pain improved from 58 at baseline to 27 at mid-term follow-up and 33 at long-term follow-up. Poor outcome, defined as a Lysholm score of 64 or less or subsequent knee replacement, was observed in 40% of the patients by 10 to 14 years after osteochondral autografting. Factors associated with a poor outcome were patient age of 40 years or older at the time of surgery, female gender, and articular cartilage defects of 3 cm2 or more. The failure rate was 83% for females 40 years or older with a defect area of 3 cm2 or more, compared with a failure rate of 12.5% for males younger than 40 years-old with an articular cartilage defect less than 3 cm2. The location of the lesion (patella-femoral vs condylar) was not a significant factor for good versus poor outcome.
 
2015 Update
A literature search conducted using the MEDLINE database through July 2015 did not identify any new literature that would prompt a change in the coverage statement.
 
In 2014, Ulstein et al reported a long-term randomized trial (median, 9.8 year; range, 4.9-11.4 years) of osteochondral transplantation versus microfracture (Ulstein, 2014).  A total of 25 patients with a lesion of the femoral condyle or trochlea, with an area between 2 and 6 cm2 and depth less than 10mm, were enrolled. All 25 patients in the study completed the questionnaires at baseline and follow-up. There were no significant differences between the osteochondral transplantation and microfracture groups in patient-reported outcomes (Lysholm, KOOS), muscle strength or radiological outcome. The mean Lysholm score improved from 49.2 to 62.6 at follow-up for the osteochondral transplantation group and from 48.2 to 69.7 following microfracture. However, 4 of 11 patients in the microfracture group underwent a second cartilage procedure compared to none in the osteochondral transplantation group. Solheim et al also found that at a mean of 12 years (range, 10-14 years) after microfracture, 45.5% of the 110 patients in their prospective cohort had poor outcomes, which included 43 patients who had additional surgery (Solheim, 2014).     
 
2017 Update
A literature search conducted through July 2017 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
OSTEOCHONDRAL AUTOGRAFT FOR ARTICULAR CARTILAGE LESIONS OF THE ANKLE
 
Osteochondral Autograft for Articular Cartilage Lesions of the Ankle Less Than 1.5 cm2
Osteochondral lesions of the talus are typically associated with ankle sprain or fracture, but comprise a relatively small proportion of lesions (»4%) compared to cartilage lesions of the knee joint.2 Therefore,
RCTs on AOT for talar lesions may be limited. One RCT with 32 patients, case series, and a systematic review of these studies have been identified on AOT for lesions of the talus.
 
Zengerink and colleagues published a systematic review on treatment of osteochondral lesions of the talus in 2010 (Zengerink, 2010). Fifty-one nonrandomized and 1 randomized trial (Gobbi, 2006) described below) were included. Studies described a variety of lesion sizes, some cystic, some as primary treatment, and some after a failed arthroscopic procedure, with follow-up of at least 6 months. Success rates averaged 85% for bone marrow stimulation, 87% for osteochondral autografting, and 76% for ACI. Because of the high cost of ACI and the knee morbidity seen with osteochondral autografting, the review concluded that bone marrow stimulation is the treatment of choice for primary osteochondral talar lesions. However, analysis was not conducted to assess the relation between lesion characteristics and success rates, limiting interpretation of these results.
 
The following sections review the evidence for lesions that have failed a prior arthroscopic procedure, and for larger lesions, defined as at least 1.5 cm2 in size. This size threshold is derived from studies that have determined bone marrow stimulation procedures for articular cartilage lesions of the talus that are at least
1.5 cm2 in area have lower success rates than for those for smaller lesions (Choi, 2009; Chuckpaiwong, 2008; Cuttica, 2011; Rampoin, 2017). For lesions less than 1.5 cm2 in size, multiple studies have shown high success rates with marrow stimulation alone.41 Because of the increase in morbidity with AOT, marrow stimulation would be the most appropriate treatment for small primary lesions. Of the relatively small number of talar osteochondral lesions, about 20% will be considered too large for marrow stimulation.38 This series reported by Choi and colleagues (Choi, 2009) also estimated that failure rate following marrow stimulation was 10.5% for lesions less than 1.5 cm2; whereas 80% of lesions at least 1.5 cm2 failed after a marrow stimulation procedure.
 
Randomized Controlled Trials
The sole RCT identified on AOT for articular cartilage lesions of the talus is by Gobbi et al (2006).37 The study included 32 patients with large (mean, ≈4 cm2; range, 1-8 cm2) lesions randomized to chondroplasty, microfracture, or AOT. Assessment at 24-month follow-up showed similar improvements
(≈40 points) for the 3 treatment groups, as measured by the American Orthopaedic Foot and Ankle
Society (AOFAS) ankle-hindfoot score (baseline score, 31-37; an AOFAS score of 90 to100 is considered excellent, 80-89 is good, 70-79 is fair, <70 is poor) and the Subjective Assessment Numeric Evaluation (baseline score, 35-36). Complication rates were also similar. Postoperative pain, measured by numeric pain intensity scores, was greater following AOT (5.25) than after chondroplasty (3.3) or microfracture (3.4). Although authors reported following subjects through a mean of 53 months (range, 24-199 months), durability results after 24 months was not reported. Thus any potential differences between hyaline and fibrocartilage at longer term follow-up cannot be determined from this study.
Observational Studies
Haleem and colleagues reported on a minimum 5-year follow-up for AOT for larger lesions of the talus (Haleem, 2014). Fourteen patients who had a double plug graft for a larger lesion (mean, 208 mm2; SD=54) were matched by age and sex to a cohort of 28 patients who had a single plug graft for a smaller osteochondral lesion (mean, 74 mm2; SD=26). Both groups had significant improvements in the Foot and Ankle Outcome Score (FAOS) and 12-Item Short-Form Health Survey scores, with no significant difference between the single-plug and double-plug groups. In the single-plug group, FAOS improved from 51.6 (SD=10.2) at baseline to 87.1 (SD=5.1) at final follow-up, while in the double-plug group the FAOS improved from 49.5 (SD=12.1) to 86.2 (SD=6.5).
 
Nonrandomized Comparative Trials
Yoon and colleagues compared outcomes for 22 patients who underwent AOT to outcomes for 22 patients who underwent repeat arthroscopy with marrow stimulation after failed treatment of osteochondral lesions of the talus (Yoon, 2014). The treatment was selected by the patient after discussion with the surgeon about the risks and benefits of the 2 procedures, including possible nonunion of the osteotomy site, donor-site morbidity, and the recovery period. The study included consecutive patients who met study criteria and had failed primary marrow stimulation. Exclusion criteria were diffuse arthritic changes or diffuse fibrillated articular cartilage or axial malalignment or chronic ankle instability. These 44 patients were among 399 patients who received arthroscopic marrow stimulation during the study period, indicating that, for about 90% of patients, primary marrow stimulation was effective. The 2 groups were comparable at baseline.  Independent and blinded evaluation showed an excellent or good outcome on AOFAS scores (≥80) in 19 (86.4%) of patients treated with AOT compared to 12 (54.5%) of patients who received repeat marrow stimulation (p=0.021). All patients showed initial improvement in the VAS and AOFAS score after 6 months, but, over a mean follow-up of 50 months, only 7 (31.8%) in the repeat marrow stimulation group achieved excellent or good results and 14 (63.6%) of this group underwent further revisions. For patients with large lesions who were treated with repeat microfracture, 100% underwent a subsequent procedure. Conversely, a significantly higher proportion of the group treated with AOT 18 (81.8%) achieved excellent or good results over a mean follow-up of 48 months and none required further revisions.
 
Imhoff and colleagues retrospectively evaluated 26 AOT procedures (25 patients) of the talus at a mean follow-up of 7 years (range, 53-124 months); 9 of the patients had failed a prior marrow stimulation procedure (Imhoff, 2011). Two additional patients had undergone a revision procedure and were not included in the follow-up data. The lesion size was less than 3 cm2 and an average of 1.5 cylinders was grafted. From baseline to follow-up, AOFAS scores improved from 50 to 78 points (p<0.01), TAS scores from 3.1 to 3.7 (p<0.05), and VAS scores for pain from 7.8 to 1.5 (p<0.01). However, outcomes were significantly worse in patients who had undergone a prior marrow stimulation procedure.
 
2018 Update
Annual policy review completed with a literature search using the MEDLINE database through July 2018. 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 Knee
 
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 (Farr, 2016). Johnson et al examined records from an institutional registry of 34 patients who, following discussion of lternative 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).

CPT/HCPCS:
27416Osteochondral autograft(s), knee, open (eg, mosaicplasty) (includes harvesting of autograft[s])
29866Arthroscopy, knee, surgical; osteochondral autograft(s) (eg, mosaicplasty) (includes harvesting of the autograft[s])

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