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 is considered investigational.
Policies with similar titles:
ADDITIONAL INFORMATION
Scientific evidence in peer-reviewed literature from controlled trials is lacking, including objective long-term outcome assessments, proper patient selection, and validated. 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 both appropriate indications as well as long-term benefits and risks.
SOURCES
BlueShield Association. Medical Policy Reference Manual. (2:2007). Meniscal allograft transplantation (7.01.15). Retrieved April 8, 2008 from BlueWeb.:(16 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)
Maitra, R. S., Miller, M. D., & Johnson, D. L. (1999). Meniscal reconstruction part I: Indications, techniques, and graft considerations. The American Journal of Orthopedics, 28 (4), 213-218.
Maitra, R. S., Miller, M. D., & Johnson, D. L. (1999). Meniscal reconstruction part II: Outcome, potential complications, and future direction. The American Journal of Orthopedics, 28 (5), 280-286.
Marx, J. A. (Ed.). (2006). Rosen’s emergency medicine: Concepts and clinical practice (6th ed., pp 792-793). Philadelphia: Mosby Elsevier.
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.
Rath, E., Richmond, J. C., Yassir, W., Albright, J. D., & Gundogen, F. (2001). Meniscal allograft transplantation: Two- to eight-year results. The American Journal of Sports Medicine, 29 (4), 410-414.
Rijk, P. C. (2004). Meniscal allograft transplantation--part I: Background, results, graft selection and preservation, and surgical considerations. Arthroscopy, 20 (7), 728-743. Abstract retrieved January 24, 2005 from PubMed database.
Rijk, P. C. (2004). Meniscal allograft transplantation--part II: Alternative treatments, effects on articular cartilage, and future directions. Arthroscopy, 20 (8), 851-859. Abstract retrieved January 24, 2005 from PubMed database.
Rodeo, S. A. (2001). Meniscal allografts--where do we stand? The American Journal of Sports Medicine, 29 (2), 246-261. Abstract retrieved June 13, 2001 from PubMed database.
Rodeo, S. A., Seneviratne, A., Suzuki, K., Felker, K., Wickiewicz, T. L., & Warren, R. F. (2000). Histological analysis of human meniscal allografts. A preliminary report. The Journal of Bone and Joint Surgery. American Volume, 82-A (8), 1071-1082. Abstract retrieved June 13, 2001 from PubMed database.
Stollsteimer, G. T., Shelton, W. R., Dukes, A., & Bomboy, A. L. (2000). Meniscal allograft transplantation: A 1- to 5-year follow-up of 22 patients. Arthroscopy: The Journal of Arthroscopic and Related Surgery, 16 (4), 343-347.
Technology Evaluation Center. (1997, August). Meniscal allograft transplantation (Vol. 12, No. 14). Chicago: BlueCross BlueShield Association. (14 articles and/or guidelines reviewed)
van Arkel, E. R., & de Boer, H. H. (2002). Survival analysis of human meniscal transplantations. The Journal of Bone and Joint Surgery. British Volume, 84 (2), 27-231. Abstract retrieved May 15, 2003 from PubMed database.
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EFFECTIVE DATE |
5/8/2008 |
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ID_BT
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