This policy addresses indications for autologous chondrocyte transplant (ACT), osteochondral allograft, osteochondral autograft (OATS/mosaicplasty) and the use of resorbable synthetic bone filler materials for the treatment of cartilaginous defects of the knee and ankle.

Medically Necessary:

The three procedures listed below:  (autologous chondrocyte transplantation [ACT], osteochondral allograft transplantation, and osteochondral autograft transplantation [OATS/mosaicplasty]), are considered medically necessary when the specific inclusion criteria are met.

• Autologous chondrocyte transplantation (ACT) also known as autologous chondrocyte implantation (ACI), to treat cartilaginous defects of the knee is considered medically necessary when all of the following criteria are met:
  1. Inadequate response to prior surgical therapy to correct the defect;
  2. Size of the cartilage defect is between 1.5 and 10 cm squared in total area;
  3. The defect involves only the cartilage and not the subchondral bone, unless ACT is being used to treat osteochondritis dissecans associated with a bony defect of less than 7mm in depth which has failed prior conservative treatment. (Lesions due to osteochondritis dissecans associated with a bony lesion greater than 7mm in depth must first undergo corrective bone grafting followed by a 6 month postoperative period to allow for healing of the cone underlying the defect prior to request for ACT).
  4. No known history of allergy to the antibiotic Gentamicin;
  5. No known sensitivities to bovine cultures;
  6. Condition involves a focal, full thickness, (grade III or IV) isolated defect of the knee involving the weight bearing surface of the medial or lateral femoral condyles or trochlear region caused by acute or repetitive trauma. [There is inadequate evidence to support the use of this procedure in lesions involving joints other than the knee or other parts of the knee (patella or tibial plateaus).]
  7. All criteria listed in the “additional inclusion criteria” section below are met.
• Osteochondral allograft transplantation to treat cartilaginous defects of the knee is considered medically necessary  when all of the following criteria are met:
  1. Arthroscopic examination results which detail the size, location and type of the defect;
  2. Size of the cartilage defect is greater than or equal to 2 cm squared in total area;
  3. Condition involves a focal, full thickness, (grade III or IV) isolated defect of the weight bearing surface of the medial or lateral femoral condyles or trochlear region caused by acute or repetitive trauma;
  4. All criteria listed in the “additional inclusion criteria” section below are met.
• Osteochondral autograft transplantation, either osteochondral autograft transplant (OATS) or mosaicplasty, to treat cartilaginous defects of the knee is considered medically necessary when all of the following criteria are met:
  1. Arthroscopic examination results which detail the size, location and type of the defect;
  2. Size of the cartilage defect is between 1.0 to 2.5 cm squared in total area;
  3. Condition involves a focal, full thickness, (grade III or IV) isolated defect of the knee involving the weight bearing surface of the medial or lateral femoral condyles or trochlear region caused by acute or repetitive trauma;
  4. All criteria listed in the “additional inclusion criteria” section below are met.

For all procedures listed above, all of the additional inclusion criteria listed below must be met:

1. Age 15-50 years
2. Persistent symptoms of disabling localized knee pain for at least 6 months, which have failed to respond to conservative treatment;
3. An intact meniscus is present;
4. The lesion must be discrete, single and unipolar (involving only one side of the joint. “Kissing lesions” are an exclusion);
5. The lesion is largely contained with near normal surrounding articular cartilage and articulating cartilage, (grades 0, 1, 2);
6. A normal joint space is present;
7. No active infection is present;
8. No inflammation or osteoarthritis is present in the joint;
9. The knee is stable, with normal alignment (corrective procedure may be performed in combination with or prior to transplantation);
10. Patient is willing and able to comply with post-operative weight-bearing restrictions and rehabilitation;
11. No history of cancer in the bones, cartilage, fat or muscle of the affected limb;
12. Body Mass Index (BMI) less than or equal to 30.

Attachments to this policy are provided for each procedure listed above.  All information identified on the appropriate sheet must be provided with requests for determination of medical appropriateness. The attachments themselves are provided for reference/guidance purposes.

Investigational/Not Medically Necessary:

Use of autologous chondrocyte transplantation, osteochondral allograft transplantation, osteochondral autograft transplantation (OATS/mosaicplasty) for joints other than the knee is considered investigational/not medically necessary, including but not limited to the ankle (talus).

Use of autologous chondrocyte transplantation, osteochondral allograft transplantation, and osteochondral autograft transplantation (OATS/mosaicplasty) are considered investigational/not medically necessary when the patient selection criteria cited above are not met.

The use of resorbable synthetic bone filler materials (including but not limited to plugs and granules) to repair osteochondral defects of the knee or ankle is considered investigational/not medically necessary.

NOTE:

This policy does not apply to allogeneic meniscal implantation. (See  TRANS.00015 Meniscal Allograft Transplantation of the Knee.)

Autologous Chondrocyte Transplantation (ACT)

The literature concerning autologous chondrocyte transplantation (ACT) for the knee consists mostly of small uncontrolled case series with patients whose lesions varied greatly in size, type and location. However, the existing studies demonstrate good results in terms of decreased pain and improved physical function in patients with small to medium chondral defects with few therapeutic options. At the time of approval, ACT was the only viable option with potential long-term benefits for young patients for whom total knee replacement was not a reasonable option. Compared to standard therapies for chondral defects such as microfracture, abrasion arthroplasty or subchondral drilling, ACT has been shown to provide durable long-term replacement of hyaline cartilage in areas with chondral defects. However, there are concerns regarding the amount of hyaline versus fibrous cartilage actually developed with ACT, continuing the need for long-term studies of this procedure.

Researchers have also been investigating the use of ACT for osteochondral defects of the ankle.  A review of the peer-reviewed scientific literature did not reveal any published controlled trials that compared the efficacy and safety of ACT for the repair of osteochondral defects of the ankle with standard therapies including subchondral drilling or microfracture.  Schafer (2003) reviewed the literature and identified four case series reports which totaled 40 patients treated for cartilage lesions of the ankle joint with chondrocyte transplant.  Results of these case series were promising although follow-up was limited (18 to 33 months) and outcome measures were varied.  It was concluded that given the limited number of patients studied, it was not possible to define indications for ACT of the talus and no conclusions could be made with regard to which specific type and size of defect would be appropriate for cartilage repair of the ankle with chondrocyte transfer.  Therefore, due to the limited scientific evidence available, conclusions regarding the efficacy, safety and durability of ACT as a treatment for osteochondral defects of the ankle cannot be made at this time.

Osteochondral Allograft

The current medical literature regarding osteochondral allografting of the knee shows that this procedure has demonstrated acceptable long-term results measured by reduction in pain, improved physical function, and sustained osteochondral graft viability. Several long-term studies have demonstrated long-term donor osteochondral grafts viability up to 10 years and one as long as 14 years with a success rate reported at 63%. Shorter term studies have reported success rates of between 75-80%. The evidence indicated that osteochondral allografting has been highly successful in patients with chondral defects resulting from trauma or osteochondritis dissecans, but less so in patients with osteonecrosis or steroid induced lesions. Finally, the literature is unanimous in emphasizing the importance of proper patient selection including adequate joint stability and alignment.

Experience with osteochondral allografts for talar cartilage defects is limited to a small number of case series (Gross 2001, Kim 2002, and Tontz 2003) totaling 28 patients.  The results reported from these small case series using varied outcome measures have been mixed and do not permit conclusions with respect to the efficacy, durability and safety of osteochondral allografts in the treatment of osteochondral defects of the ankle.

Osteochondral Autograft Transplantation (OATS/Mosaicplasty)

The medical literature regarding osteochondral autograft transplant (OATS) and mosaicplasty of the knee consists mostly of single-institution case series focusing on chondral lesions of the knee. These studies include heterogeneous populations of patients, some of whom are undergoing treatment for additional abnormalities such as ligament or meniscal repair. Therefore, it is not known whether improvement in symptoms can be attributed to the osteochondral autografting or other components of the surgery. In addition, there are very few studies currently available comparing the results of osteochondral autografting with other established therapies. However, there is a large collection of small studies demonstrating that osteochondral autografting procedures, including mosaicplasty, confer significant benefit in terms of both functional improvement and pain relief in a population where alternative therapies are limited. Several studies have evaluated the long term viability of osteochondral autografts with histological examinations at up to three years post-transplant. The vast majority of these studies report finding stable hyaline cartilage at the operative site. In almost all articles published, patients with misalignment, arthritis, unstable knees, and missing or compromised meniscus, were excluded from the studies due to concerns regarding suitability for the procedures. Finally, there is little agreement on any limitations regarding the size of chondral defects that are appropriate for these procedures. The medical literature suggests that mosaicplasty might be appropriate for lesions ranging from as little as 1.5 cm² to as large as 16 cm². Most recent evidence supports the position that the larger the chondral defect, the higher the complication rate and rates of donor site morbidity. Thus, at this time it may be appropriate to limit these procedures to small to moderate lesions, between 1.1 and 2.5 cm², until further evidence is available to fully evaluate this issue.

Studies of the use of autografts in the treatment of osteochondral lesions of the ankle talus are largely case series in design.  Hangody et al (2001) reported the clinical outcome of 36 consecutive patients followed for two to seven years after autologous transplantation mosaicplasty from a non-weight bearing portion of the knee to the ipsilateral ankle talus. The average size of the defects treated was one centimeter. Patients with osteoarthritis were excluded from the study.  Most patients (29 of the 34) had previous surgical intervention(s) including arthroscopic debridement, loose body removal, drilling, curettage and/or microfracture.  All patients achieved full range of motion within eight weeks following surgery.  Average follow-up for the entire series was 4.2 years (2-7 years).  Five patients were followed to seven years.  No patients at the end of follow-up showed loosening of the graft.  Using a standardized scoring tool (Hannover), results of 28 cases were rated “excellent”, six were rated “good”, and two “moderate”.  There were no cases with long term donor site morbidity. 

Scranton (2006) published a retrospective case series study of the outcomes of 53 consecutive patients with Type-V talar osteochrondral defects treated with autograft plugs harvested arthroscopically from the ipsilateral knee.  The type V lesions treated were confined to those with a diameter of 8mm to 20mm confirmed by CT or MRI.  The majority of patients (32 or 64%) had previously undergone one or more prior ankle surgical procedures including debridement, curettage, drilling, internal fixation or grafting.  A total of 40 patients had symptoms for more than one year.  The majority of patients had also received at least six months of prior conservative treatment which included rest, immobilization and physiotherapy without improvement.  Two patients were lost to follow-up and one patient died of unrelated cause one year following the procedure.  Of the 50 patients evaluated at a mean follow-up of 36 months (24-83), 45 (90%) achieved “good” to “excellent” score in the Karlsson-Peterson Ankle questionnaire and were satisfied with the outcome.  The outcome questionnaire used was a standardized assessment of eight functional outcome measures of ankle stability, pain, swelling, stiffness, activities of daily living (ADL), stair climbing, running and use of ankle supports (Karlsson J. 1991).  Although each patient had presented with what were described as disabling symptoms of swelling, catching or pain with activity refractory to conservative therapies, baseline Karlsson-Peterson Ankle scores were not measured. 

Kreuz et al (2006) recently reported a prospective case series of 35 patients with Stage III or IV (cystic) (Loomer 1993) osteochondral talar lesions treated with mosaicplasty using autologous grafts harvested from a low weight bearing area of the ipsilateral talar articular facet.  All patients had previously failed surgery on the same ankle which included drilling, removal of loose body, or abrasion arthroplasty.  Mean lesion size was 6.3 mm in diameter (4mm-10mm).  Twenty patients required either a malleolar or tibial wedge osteotomy to access the lesion, while 15 had either an anterior or postero-lateral approach without osteotomy.  The American Orthopedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot survey was administered before the procedure and at the end of follow-up. Mean follow-up period was 49 months.  The AOFAS Ankle-Hindfoot survey is a recognized method of reporting the clinical status of the ankle and foot.  This tool incorporates both subjective and objective clinical measures of pain, function, range of motion, and alignment.  In this case series, the mean preoperative AOFAS score was 54.5 of 100 points (47-60).  Overall improvement between pre-operative and follow-up (mean 49 months) AOFAS scores was 35.4 points (26-48) with a mean follow-up score of 89.9 (P≤0.017).  AOFAS score in patients not requiring osteotomy rose by 39 points (P=0.0001), with malleolar osteotomy by 30.1 points (P=0.017), with tibial wedge osteotomy by 34.9 points (P=0.0002), and with postero-lateral approach by 32 points (P not reported).

A recent randomized controlled trial comparing the outcomes of chondroplasty, microfracture, and osteochrondral autograft transplantation (OAT) in 32 patients with osteochondral lesions of the talus was reported (Gobbi 2006).  Patients with Ferkel class 2b, 3, and 4 osteochondral lesions of the talus were randomized to one of the three treatments and outcomes measured with the AOFAS scale and a subjective assessment numeric evaluation tool (SANE) rating.  Eleven patients had chondroplasty, 9 patients had microfracture, and 12 patients had OAT.  Mean time to follow-up was 53 months (24-119).  There were no differences at 12 and 24 months in AOFAS scores or in SANE ratings at the end of follow-up between the three groups of patients studied.  This recent study is limited by size, but is one of the few which used a randomized, prospective design with comparison of the varied treatment options available for the treatment of osteochondral lesions of the talus.  The study did not include a non-surgical control group.

More recently, there has been interest in the use of the PolyGraft® material (polylactide-co-glycolide (PLG) copolymer, calcium sulfate, polyglycolide (PGA) fibers and surfactant) to repair osteochondral defects. The only published, peer-reviewed-scientific literature found on PolyGraft® consisted of seven small studies carried out on animals.  There were no published peer-reviewed clinical trials on humans.  Therefore, there is insufficient scientific evidence to allow conclusions regarding the safety and efficacy of the use of this technology in humans at this time.

Autologous Chondrocyte Transplantation (ACT)

Autologous chondrocyte transplantation (ACT) has been studied as a possible method of repairing symptomatic defects of the articular cartilage of the knee. Healthy cartilage cells (chondrocytes) are obtained from the patient via arthroscopy. These cells are then isolated and cultured in a laboratory for four to five weeks. Surgery is performed to remove the chondral defect. This area is then covered with a small bone flap, taken from the tibia (shin bone), and the cultured chondrocytes are injected under the flap.

Genzyme Tissue Repair markets its autologous chondrocyte product under the name Carticel™.  Carticel™ is currently approved by the Food and Drug Administration (FDA) for the “repair of symptomatic, cartilaginous defects of the femoral condyle (medial, lateral or trochlear), caused by acute or repetitive trauma, in patients who have had an inadequate response to a prior arthroscopic or other surgical repair procedure”.

Osteochondral Allograft

Osteochondral allografting involves transplantation of a piece of articular cartilage and attached subchondral bone from a cadaver donor to a damaged region of the articular surface of a joint. This procedure is considered one of the alternatives for repairing articular cartilage defects. The donor grafts consist of the articular surface with an underlying segment of bone that helps to secure the graft to the underlying host bone.

Osteochondral Autograft Transplantation (OATS/Mosaicplasty)

In osteochondral autograft mosaicplasty, a series of small bone and cartilage grafts are harvested from a non-weight-bearing region of the joint during an arthroscopic procedure and then transplanted into the cartilage defect where they contribute to regeneration and repair of the articular surface while the bone remains undisturbed.  The bone base of the transplant acts as an anchor and enables secure fixation and integration with surrounding bone.  In mosaicplasty, this is done in a mosaic pattern. The OATS procedure is similar to mosaicplasty, involving the use of a larger, single plug that generally fills the entire osteochrondral defect.

Non-autologous mosaicplasty has been proposed as an alternative to conventional mosaicplasty.  In non-autologous mosaicplasty a series of small holes are drilled into the area of the osteochondral defect.  The holes are then gently packed with a synthetic polymer.  The synthetic material provides a bone void filler and provides a scaffold for the growth of new bone.  The synthetic graft is gradually resorbed by the body and replaced with bone.  This procedure may be preferred over conventional osteochondral autograft transplantation because it eliminates the need for harvesting bone and cartilage from the donor graft site.

Smith & Nephew, Inc., (formerly OsteoBiologics, Inc. [ODI]), markets non-autologous bone filler product under the name of PolyGraft® which consists of polylactide-co-glycolide (PLG) copolymer, calcium sulfate, polyglycolide (PGA) fibers and surfactant. According to the FDA label indications, PolyGraft® can be used “to fill bony voids or gaps caused by trauma or surgery that are not intrinsic to the stability of the bony structure” and may be “combined with autogenous blood products, such as platelet rich plasma, and/or sterile fluids, such as saline or Ringer’s solution”.  Smith & Nephew Inc. manufactures several products which contain the PolyGraft® material including, but not necessarily limited to, TruFit® BGS Plugs and the TruFit® granules. 

As mentioned above, research on the use of non-autologous bone filler materials has been limited to small studies on animals, and there is insufficient scientific evidence to allow conclusions regarding the safety and efficacy of the use of this technology in humans at this time.

Articulating cartilage: a tough, spongy material that covers the ends of bones and may be present in the areas between bones (joints) to protect the bones and act as a shock absorber

Arthroscopic surgical repair: a surgical procedure using specialized video-guidance and instruments to operate on a joint without opening the surgical area in the traditional manner

Autologous chondrocyte transplantation (ACT): also known as autologous chondrocyte implantation (ACI); this is a surgical procedure where cartilage cells are removed from a patient and grown in a lab to create more cells; these cells are then implanted into the knee at areas where there are cartilage defects, in the hope that the transplanted cells take hold and heal the defects

BMI (body mass index): the weight in kilograms, divided by height in meters squared *Note: to convert pounds to kilograms, multiply pounds by 0.455, to convert inches to meters, multiply inches by 0.0254.

Femoral condyle: the end of the thigh bone nearest the knee

Meniscus: a piece of cartilage, a tough, spongy material, that lies in the knee joint, between the ends of the bones which acts as a shock absorber

Mosaicplasty (autologous): a surgical procedure where one or several plugs of bone, along with its articular cartilage, is taken from one area of the knee of a patient and transplanted to another part of the knee on the same patient

Mosaicplasty (non-autologous): a surgical procedure where one or several plugs of defective bone, along with its articular cartilage, is removed and replaced with synthetic material

Subchondral bone: bone that lies directly underneatharticulating cartilage

Osteoarthritis: a degenerative condition of the cartilage in the joints resulting in loss of motion and pain

Osteochondral allograft transplantation: a surgical procedure where a portion of bone, along with its articular cartilage, is taken from another person and transplanted into the patient

Osteochondral autograft transplant (OATS): a surgical procedure where a portion of bone, along with its articular cartilage, is taken from one area of a patient and transplanted to another location on the same patient

Osteochondritis dissecans: a condition where a loss of the blood supply to an area of bone underneath a joint surface results in the affected bone and its covering of cartilage gradually loosening and causing pain

The following codes for treatments and procedures applicable to this policy are included below for informational purposes.  Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member’s contract benefits in effect at the time of service to determine coverage or non-coverage or these services as it applies to an individual member.

When services may be Medically Necessary when criteria are met:

CPT

HCPCS

ICD-9 Diagnosis

When services are Investigational/Not Medically Necessary:

For procedure codes listed above when criteria are not met, for all other diagnoses not listed, or when the code describes a procedure indicated in the Policy section as investigational/not medically necessary.

When services are also Investigational/Not Medically Necessary:

CPT

ICD-9 Diagnosis

Peer Reviewed Publications:

1. Alleyne KR, Galloway MT. Management of osteochondral injuries of the knee. Clin Sports Med. 2001; 20(2): 343-364.
2. Al-Shaikh RA, Chou LB, Mann, JA, et al.  Autologous osteochondral grafting for talar cartilage defects. Foot Ankle Int.  2002; 25(5): 381-389.
3. Athanasiou KA, Niederauer GG, Agrawal CM, et al. Applications of biodegradable lactides and glycolides in podiatry. Clin Podiatr Med Surg. 1995 Jul;12(3):475-95.
4. Athanasiou KA, Niederauer GG, Schenck RC Jr. Biomechanical topography of human ankle cartilage. Ann Biomed Eng. 1995 Sep-Oct;23(5):697-704.
5. Aubin PP, Cheah HK, Davis AM, et al. Long-term follow up of fresh femoral osteochondral allografts for posttraumatic knee defects.  Clin Othoped Rel Res. 2001; 391 Supplement: S318-S327.
6. Bentley G, Minas T.  Treating joint damage in young people.  BMJ. 2000; 320(7249): 1585-1588.
7. Bobic V, Noble J.  Articular cartilage-to repair or not to repair.  J Bone Joint Surg. 2000; 82-B (2): 165-6.
8. Boyan BD,  Lohmann CH, Somers A, et al. Potential of porous poly-D,L-lactide-co-glycolide particles as a carrier for recombinant human bone morphogenetic protein-2 during osteoinduction in vivo. J Biomed Mater Res. 1999 Jul;46(1):51-9.
9. Bradley JP, Petrie RS. Osteochondritis dissecans of the humeral capitellum, diagnosis and treatment. Clin Sports Med. 2001; 20(3): 565-590.
10. Brittberg M, Lindahl A, Nilsson A, et al. Treatment of deep cartilage defects in the knee with autologous chondrocyte transplantation. NEJM. 1994; 331(14): 889-895. 
11. Bugbee WD, Convery FR. Osteochondral allograft transplantation. Clin Sports Med. 1999; 18(1): 67-75. 
12. Cain EL, Clancy WG. Treatment algorithm for osteochondral injuries of the knee. Clin Sports Med. 2001; 20(2): 321-342.
13. Chu CR, Convery FR, Akeson WH, et al.  Articular cartilage transplantation.  Clinical results in the knee.  Clin Orthop Rel Res. 1999; (360): 159-68.
14. Duchow J, Hess T, Kohn D.  Primary stability of press-fit-implanted osteochondral grafts. Influence of graft size, repeated insertion, and harvesting technique.  Am J Sports Med. 2000; 28(1): 24-7.
15. Ghazavi MT, Pritzker KP, Davis AM, et al.  Fresh osteochondral allografts for post-traumatic osteochondral defects of the knee. J Bone Joint Surg. 1997; 79-B (6): 1008-1013.
16. Gillogly SD, Voight M, Blackburn T.  Treatment of articular cartilage defects of the knee with autologous chondrocyte implantation.  JOSPT. 1998; 28(4): 241-251.
17. Gobbi A, Francisco RA, Lubowitz JH, Allegra F, Canata G. Arthroscopy 2006 Oct;22(10):1085-92.
18. Grande DA, Breitbart AS, Mason J, et al.  Cartilage tissue engineering: current limitations and solutions.  Clin Ortho Rel Res. 1999; 367S: S176-S185.
19. Gross AE, Agnidis Z, Hutchison CR. Osteochrondral defects of the talus treated with fresh osteochondral allograft transplantation. Foot ankle Int 2001;22(5):385-91.
20. Hangody L. The mosaicplasty technique for osteochondral lesions of the talus. Foot Ankle Clin - 01-JUN-2003; 8(2): 259-73.
21. Hangody L, Feczko P, Bartha L, et al.  Mosaicplasty for the treatment of articular defects of the knee and ankle.  Clin Orthoped Rel Res. 2001; 391S:S328-S336.
22. Horas U, Pelinkovic D, Herr G, et al.  Autologous chondrocyte implantation and osteochondral cylinder transplantation in cartilage repair of the knee.  J Bone Joint Surg. 2003; 85-A (2): 185-192.
23. Jakob RP, Franz T, Gautier E, et al.  Autologous Osteochondral grafting in the knee: Indication, results, and reflections. Clin Ortho Rel Res. 2002; 401:179-184.
24. Karlsson J Peterson L. Evaluation of ankle joint function: the use of a scoring scale. The Foot 1991;1:15-19.
25. Kim CW, et al. Treatment of post-traumatic ankle arthrosis with bipolar osteochondral shell allografts. Foot Ankle Int 2002;23:1091.
26. Kish G, Modis L, Hangody L. Osteochondral mosaicplasty for the treatment of focal chondral and osteochondral lesions of the knee and talus in the athlete. Rationale, indications, techniques, and results.  Clin Sports Med. 1999; 18(1): 45-66.
27. Kreuz PC, Steinwachs M, Erggelet C, et al. Mosaicplasty with autogenous talar autograft for osteochondral lesions of the talus after failed primary arthroscopic management: a prospective study with a 4-year follow-up. Am J Sports Med. 2006 Jan;34(1):55-63.
28. Lohmann CH, Schwartz Z, Niederauer GG, et al. Degree of differentiation of chondrocytes and their pretreatment with platelet-derived-growth factor. Regulating induction of cartilage formation in resorbable tissue carriers in vivo. Orthopade. 2000 Feb;29(2):120-8.
29. Lohmann CH, Schwartz Z, Niederauer GG, et al. Pretreatment with platelet derived growth factor-BB modulates the ability of costochondral resting zone chondrocytes incorporated into PLA/PGA scaffolds to form new cartilage in vivo. Biomaterials. 2000 Jan;21(1):49-61.
30. Loomer R, Fischer C. Osteochondral lesions of the talus. Am J Sports Med. 1993;21:13-19.
31. Mandelbaum BR, Browne JE, Fu F, et al.  Articular cartilage lesions of the knee.  Am J Sports Med. 1998; 26(6): 853-861.
32. Marcacci M, Kon E, Zaffagnini S, Visani A.  Use of autologous grafts for reconstruction of osteochondral defects of the knee.  Orthopedics. 1999; 22(6): 595-600.
33. Minas T.  Chondrocyte implantation in the repair of chondral lesions of the knee: economics and quality of life.  Am J Ortho 1998; 1-5.
34. Minas T, Chiu R.  Autologous Chondrocyte Implantation.  Am J Knee Surg, 2000; 13(1): 41-50. 
35. Minas T, Peterson L.  Advanced techniques in autologous chondrocyte transplantation.  Clin Sports Med. 1999; 18(1): 13-44.
36. Minas T, Nehrer S.  Current concepts in the treatment of articular cartilage defects.  Orthop. 1997; 20(6): 525-538.
37. Mont MA, Jones LC, Vogelstein BN, et al. Evidence of inappropriate application of autologous cartilage transplantation therapy in an uncontrolled environment. Am J Sports Med. 1999; 27(5): 617-620.
38. Niederauer GG, Slivka MA, Leatherbury NC, et al. Evaluation of multiphase implants for repair of focal osteochondral defects in goats. Biomaterials. 2000 Dec;21(24):2561-74.
39. Peterson L, Minas T, Brittberg M, et al. Treatment of osteochondritis dissecans of the knee with autologous chondrocyte transplantation results at two to ten years. J Bone Joint Surg. 2003; 85-A (S2): 17-24.
40. Peterson L, Minas T, Brittberg M, et al. Two-to 9-year outcome after autologous chondrocyte transplantation of the knee.  Clin Orthop Rel Research. 2000; 374:212-234. 
41. Salai M, Ganel A, Horozowski H.  Fresh osteochondral allografts at the knee joint: good functional results in a follow-up study of more thgan15 years. Acrh Orthop Trauma Surg. 1997; 116:423-425.
42. Schafer DB, Cartilage repair of the talus. Foot and Ankle Clinics N Am(8) 2003, 739-749.
43. Scranton PE Jr. Outcome of osteochondral autograft transplantation for type-V cystic osteochondral lesions of the talus. J Bone Joint Surg Br - 01-MAY-2006; 88(5): 614-9.
44. Slivka MA, Leatherbury NC, Kieswetter K, et al. Porous, resorbable, fiber-reinforced scaffolds tailored for articular cartilage repair. Tissue Eng. 2001 Dec;7(6):767-80.
45. Tontz Wl, Bugbee WD, Brage ME. Use of allografts in the management of ankle arthritis. Foot and Cankle Clinics, 8(2) 361-373 2003.
46. Verhagen RA. Systematic review of treatment strategies for osteochondral defects of the talar dome. Foot Ankle Clin - 01-JUN-2003; 8(2): 233-42, viii-ix.

Government Agency, Medical Society, and Other Authoritative Publications:

1. Blue Cross Blue Shield Association. Autologous chondrocyte transplantation. TEC Assessment 1998; Volume 12: 26.
2. Blue Cross Blue Shield Association. Technology Evaluation Center (TEC) assessment. Autologous Chondrocyte Transplantation of the Knee. Volume 18, No. 2. June 2003.
3. Hayes Medical Technology Directory. Autologous chondrocyte transplantation of the Knee. Winifred S. Hayes, Inc. Lansdale, PA; January 9, 2005. Updated January 7, 2006.
4. Hayes Medical Technology Directory. Mosaicplasty. Winifred S. Hayes, Inc., Lansdale, PA; June 4, 2005. Updated June 3, 2006.
5. Hayes Medical Technology Directory. Osteochondral allografting for the knee. Winifred S. Hayes, Inc., Lansdale, PA. September 9, 2000. Updated March 15, 2006.
6. National Institute for Health and Clinical Excellence. Technology Appraisal Guidance No. 89. The use of autologous chondrocyte implantation for the treatment of cartilage defects in knee joints. May 2005.  http://www.nice.org.uk/page.aspx?o=TA089guidance.  Accessed October 9, 2006.
7. U. S. Food and Drug Administration (FDA). Product approval information - Licensing Action. March 2, 2000. Updated March 5, 2001. Available at:  http://www.fda.gov/cber/products/autogen030200.htm Accessed October 9, 2006.
8. U. S. Food and Drug Administration (FDA). Product approval information for PolyGraft®. 510(k) Summary. July 17, 2003. Available at:  http://www.fda.gov/cdrh/pdf3/k030288.pdf  Accessed October 9, 2006.
   

ACI
ACT
Autologous Chondrocyte Transplant/Implant

Carticel™

Cartilage Implants

Implant, Chondrocyte

Manipulated Autologous Structural Cells

MAS

Mosaicplasty

OATS
OsteoBiologics Inc. (OBI) Implants

Osteoarthritis

Osteochondral Autograft Transplant
Transplant, Chondrocyte
TruFit®
TruGraft®

The use of specific product names is illustrative only.  It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

Note: this form is provided as a guide for collection of information only                                                                       

Attachment A

Autologous Chondrocyte Transplantation of the Knee

Medical Review Sheet (use of this form is optional)

Note: this form is provided as a guide for collection of information only      

Attachment B

Osteochondral Allograft Transplantation of the Knee

Medical Review Sheet

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