Meniscal Allografts and Collagen Meniscus Implants
DESCRIPTION
Historically, the role of normal meniscal cartilage was greatly under appreciated; torn and damaged menisci were routinely excised. However, it is now known that the menisci are an integral structural component of the human knee and function to absorb shocks, provide joint stability, congruity, and nutrition. In addition, total and partial meniscectomy are associated with altered load bearing across the joint, frequently resulting in degenerative osteoarthritis. The integrity of the menisci are particularly important in knees in which the anterior cruciate ligament (ACL) has been damaged; in these situations, the menisci act as secondary stabilizers of anteroposterior and varus-valgus translation. With this greater understanding, the surgical principles of treating torn or damaged menisci evolved to their repair and preservation whenever possible. Moreover, meniscal allograft transplantation has been investigated in individuals with a previous meniscectomy or requiring total or near total meniscectomy for irreparable tears. Meniscal allografts are transplanted either by arthroscopic insertion or by open techniques utilizing arthrotomy of the knee joint. The anchoring of the meniscal horns is a critical part of this procedure. Anchoring has been accomplished using soft-tissue attachments, bone plugs, or a bony bridge connecting the anterior and posterior horns. Most cases of early reported failure in experimental and clinical cases involved loss of fixation of the meniscal horns. Soft-tissue attachments in particular have not proven to be secure enough to withstand the stresses generated during weight bearing. Anchoring utilizing bone-to-bone healing (e.g., bone plugs) has resulted in increased fixation and stability of the transplanted menisci.
There are 3 general groups of individuals who have been treated with meniscal allograft transplantation:
Those with pain and discomfort associated with early osteoarthrosis
Those who are undergoing ACL reconstruction in whom a concomitant meniscal transplant is intended to provide increased stability
Athletes with few symptoms in whom the allograft transplantation is intended to deter the development of osteoarthritis
The following different types of allografts have been investigated:
Fresh - Fresh implants, harvested under sterile conditions, typically are not a practical option. The grafts must be used within a couple of days to maintain viability. Also, there are concerns regarding infectious diseases, such as HIV, and furthermore the grafts must be appropriately sized.
Frozen - After sterile harvest, the meniscus can be frozen for storage until thawed for use. The freezing process may destroy donor cells and decrease the size of the graft.
Freeze Dried (Lyophilized) - In addition to freezing, the tissue may be dehydrated, permitting storage at room temperature. Before transplantation, the graft is thawed and rehydrated.
Cryopreserved - Cryopreserved freezes the graft in glycerol, preserving the cell membrane integrity and donor fibrochondrocyte viability. Of all the above options, cryopreserved grafts are most commonly used (e.g., Cryolife of Marietta, GA is a commercial supplier of such grafts).
The risk of infectious disease, particularly HIV or hepatitis, continues to be a concern. Several secondary sterilization techniques have been used, with gamma irradiation the most common.
Tissue engineering that grows new replacement host tissue for individual patients is also being investigated. For example, the ReGen Collagen Scaffold (ReGen Biologics), which may also be referred to as the Menaflex™ collagen meniscus implant or CMI™, is a resorbable collagen matrix comprised primarily of bovine type I collagen. The implant is provided in a semilunar shape and trimmed to size for suturing to the remaining meniscal rim. The implant provides an absorbable collagen scaffold that is replaced by the patient’s own soft tissue; it is not intended to replace normal body structure. The ReGen Collagen Scaffold received 510(k) marketing clearance from the U.S. Food and Drug Administration (FDA) in 2008. The FDA determined that this collagen scaffold was substantially equivalent to existing predicate absorbable surgical mesh devices. This is the first resorbable collagen matrix to be intended for the reinforcement and repair of soft tissue injuries of the medial meniscus. Other scaffold materials and cell-seeding techniques are being investigated.
POLICY
Meniscal allograft transplantation for the treatment of a symptomatic, meniscus deficient knee is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Meniscal allograft transplantation for the treatment of focal articular cartilage lesions is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Meniscal allograft transplantation for the treatment of other conditions/diseases is considered investigational.
Collagen meniscus implantation for the treatment of, including but not limited to, a symptomatic, meniscus deficient knee is considered investigational.
Any device utilized for this procedure must have FDA approval specific to the indication, otherwise it will be considered investigational.
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MEDICAL APPROPRIATENESS
Meniscal allograft transplantation is considered medically appropriate when ANY ONE of the following criteria are met:
Treatment of a symptomatic, meniscal deficient knee when ALL of the following criteria are met:
Absence or near absence (more than 50%) of the meniscus, established by imaging or prior surgery
Symptoms are related to the affected side
An adolescent should be skeletally mature with documented closure of growth plates
Adult patients should be too young to be considered an appropriate candidate for total knee arthroplasty or other reconstructive knee surgery (e.g., younger than 55 years)
Disabling knee pain with activity that is refractory to conservative treatment
Documented minimal to absent degenerative changes in the surrounding articular cartilage (Outerbridge grade II or less)
Normal knee biomechanics, or alignment and stability achieved concurrently with meniscal transplantation
Has a body mass index (BMI) of ≤ 35 kg/m2
ABSENCE of ALL of the following:
Infection
Inflammatory arthritis
Synovial disease
Treatment of focal articular cartilage lesions when performed in combination, either concurrently or sequentially, with autologous chondrocyte implantation, osteochondral allografting or osteochondral autografting (OCG). (Note: Medical Necessity for any one of these three procedures must be established before approving meniscal allograft transplantation for this condition).
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
ADDITIONAL INFORMATION
The evidence is insufficient to permit conclusions concerning the effects of collagen meniscus implants on health outcomes. In addition to FDA approval, mid-to long-term follow-up with a large number of subjects is need to determine whether implantation of a collagen scaffold is able to slow joint degeneration, reduce pain, and improve overall net health outcomes.
Severe obesity, e.g., body mass index (BMI) greater than 35 kg/m2, may affect outcomes due to stress on weight bearing surfaces of the joint. Meniscal allograft transplantation is typically recommended for young active individuals who are too young for total knee arthroplasty.
SOURCES
American Academy of Orthopaedic Surgeons. (2009). Your orthopaedic connection. Meniscal transplant surgery. Retrieved June 21, 2011 from http://orthoinfo.aaos.org/topic.cfm?topic=A00381&return_link=0.
BlueShield Association. Medical Policy Reference Manual. (3:2011). Meniscal allografts and collagen meniscus implants (7.01.15). Retrieved June 20, 2011 from BlueWeb. (35 articles and/or guidelines reviewed)
Centers for Medicare and Medicaid Services (CMS). (2010) Decision memo for collagen meniscus implant (CAG-00414N). Retrieved June 21, 2011 from http://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=235&ver=8&NcaName=Collagen+Meniscus+Implant&bc=BEAAAAAAEAAA&&fromdb=true.
Complete Guide to Medicare Coverage Issues [Computer software]. (2011, April). Collagen meniscus implant (NCD 150.12, p. 2-77). Ingenix.
Elattar, M., Dhollander, A., Verdonk, R., Almqvist, D. F., & Verdonk, P. (2011). Twenty-six years of meniscal allograft transplantation: Is it still experimental? A meta-analysis of 44 trials. Knee Surgery, Sports Traumatology, Arthroscopy, 19 (2):147-157. Abstract retrieved June 21, 2011 from PubMed database.
Hergan, D., Thut, D., Sherman, O., & Day, M. A. (2011). Meniscal allograft transplantation. Arthroscopy, 27 (1), 101-112. Abstract retrieved June 21, 2011 from PubMed database.
Hommen, J.P., Applegate, G.R., & Del Pizzo, W. (2007). Meniscus allograft transplantation: ten-year results of cryopreserved allografts. Arthroscopy: The Journal of Arthroscopic and Related Surgery, 23 (4), 388-393.
Matava, M.J.. (2007). Meniscal allograft transplantation - a systematic review. Clinical Orthopedics and Related Research, 455, 142-157.
Packer, J.D., Rodeo, S.A. (2009). Meniscal allograft transplantation. Clinical Sports Medicine, 28 (2), 259-283.
Stone, K. R., Adelson, W. S., Pelsis, J. R.Walgenbach, A. W. & Turek, T. J. (2010). Long-term survival of concurrent meniscus allograft transplantation and repair of the articular cartilage: A prospective two- to 12-year follow-up report. The Journal of Bone and Joint Surgery, British volume, 92 (7), 941-948. Abstract retrieved June 21, 2011 from PubMed database.
Winifred S. Hayes, Inc., Medical Technology Directory. (2010, December). Meniscal allograft transplantation. Retrieved October 13, 2011 from www.Hayesinc.com/subscribers. (39 articles and/or guidelines reviewed)
ORIGINAL EFFECTIVE DATE: 6/1/2000
MOST RECENT REVIEW DATE: 11/12/2011
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