Meniscal Allograft Transplantation
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.
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 when performed in combination, either concurrently or sequentially, with autologous chondrocyte implantation or osteochondral allografting, is considered investigational.
Meniscal allograft transplantation for the treatment of other conditions/diseases is considered investigational.
Any device utilized for this procedure must have FDA approval specific to the indication, otherwise it will be considered investigational.
Policies with similar titles:
MEDICAL APPROPRIATENESS
Meniscal allograft transplant for the treatment of a symptomatic, meniscal deficient knee is considered medically appropriate if ALL of the following criteria are met:
The individual has had a prior meniscectomy
Symptoms are related to the affected side
Adolescent patients should be skeletally mature with documented closure of growth plates (e.g., 15 years or older)
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
Absence or near absence (more than 50%) of the meniscus, established by imaging or prior surgery
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
The individual has a body mass index (BMI) less than or equal to 35 kg/m2
ABSENCE of ALL of the following:
Infection
Inflammatory arthritis
Synovial disease
ADDITIONAL INFORMATION
Scientific evidence in peer-reviewed literature from controlled trials is lacking, including objective long-term outcome assessments and proper patient selection criteria. It is also unknown whether grafts either protect articular cartilage or delay progression of arthritis. Studies of meniscal allograft replacement in humans consist mostly of small, uncontrolled case series. Objective evaluation of the results with either MRI or arthroscopy was reported in a minority of the reported cases. Reports with long-term follow-up (i. e., more than 5 years) were also lacking. Patients in uncontrolled trials have reported a decrease in pain, but entry and outcome assessment criteria vary widely, as do concomitant procedures performed with the meniscal replacement. Additional data from controlled trials are needed to confirm appropriate indications as well as long-term benefits and risks.
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 patients who are too young for total knee arthroplasty.
SOURCES
Amendola, A. & Stolley, M.P. (2009). What do we really know about allografts? Clinical Sports Medicine, 28 (2), 215-222.
BlueShield Association. Medical Policy Reference Manual. (11:2008). Meniscal allograft transplantation (7.01.15). Retrieved April 14, 2009 from BlueWeb. (23 articles and/or guidelines reviewed)
ECRI Institute. Health Technology Assessment Information Service. Windows on medical technology. (2001, August). Meniscal allograft transplantation for damaged or removed meniscus. Retrieved May 15, 2003 from ECRI Institute. (61 articles and/or guidelines reviewed)
Hayes. Medical Technology Directory. (2004, April). Meniscal allograft. Retrieved August 9, 2006 from http://www.Hayesinc.com/subscribers. (40 articles and/or guidelines reviewed)
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.
Marx, J. A. (Ed.). (2006). Rosen’s emergency medicine: Concepts and clinical practice (6th ed., pp 792-793). Philadelphia: Mosby Elsevier.
Matava, M.J.. (2007). Meniscal allograft transplantation- a systematic review. Clinical Orthopedics and Related Research, 455, 142-157.
McCarty, E. C., Marx, R. G., & DeHaven, K. E. (2002). Meniscus repair: Considerations in treatment and update of clinical results. Clinical Orthopaedics and Related Research, (402), 122-134.
Packer, J.D., Rodeo, S.A.(2009). Meniscal allograft transplantation. Clinical Sports Medicine, 28 (2), 259-283.
ORIGINAL EFFECTIVE DATE: 6/1/2000
MOST RECENT REVIEW DATE: 11/14/2009
ID_BT
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
This document has been classified as public information.