DESCRIPTION
The anterior cruciate ligament (ACL) is located in the center of the knee and holds the femur and the tibia in place. The ACL attaches from the back of the femur to the front of the tibia. The ACL is one of the most important ligaments to athletes because it functions to stabilize the joint during deceleration movements.
ACL reconstruction is generally an arthroscopic procedure. Before the reconstruction, an arthroscope is used to carefully survey the whole joint. Once the injured ACL is removed, the allograft is placed in the same position as the original ACL and fastened securely in place with two "interference fit" screws. The purpose for this procedure is stabilization of the knee.
POLICY
Allograft anterior cruciate ligament reconstruction for the treatment of ACL deficiency is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Policies with similar titles:
MEDICAL APPROPRIATENESS
Allograft ACL reconstruction is considered medically appropriate for an individual who is not a candidate for autogenous transplantation due to ANY ONE of the following:
Autogenous tissue that has been compromised (e.g., by previous surgery, previous injury)
Multi-ligament reconstruction is being performed
Pathology such as chronic patellar tendonitis and hamstring injury exists
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
According to the American Association of Tissue Banks, allograft tissue (tissue from another person's body) is used by surgeons because of the inadequate amount of available autograft tissue (a person's own bone or soft tissue). Allograft tissue is commonly used in reconstructive surgeries and in cases of bone loss due to trauma or tumors.
Donor-recipient matching is done primarily by size to ensure optimum fit of the allograft; tissue typing is not required since the allograft is only minimally immunogenic. Screening, collection and processing of the donor grafts include the following steps:
Screening of donors using American Association of Tissue Banks (AATB) schema to rule out groups at high risk for human immunodeficiency virus (HIV) infection and systemic disease, including infection, neoplasia and arthritis. Screening of blood for types B and C hepatitis, syphilis, and HIV disease.
Culturing of donor tissues for bacterial and fungal infection.
Lymph node evaluation at autopsy.
Harvesting of the grafts under sterile conditions, preferably within 12 hours of death.
Preservation of the specimens in a tissue culture solution containing antibiotics at 4° C until transplantation. Transplantation usually occurs within 3 days. Although tissue is cryopreserved, most investigators use fresh graft material.
SOURCES
American Academy of Orthopaedic Surgeons (AAOS). (2011, June). Advisory statement. Use of musculoskeletal tissue allografts. Retrieved December 16, 2011 from http://www.aaos.org/about/papers/advistmt/1011.asp.
Baer, G. S., & Harner, C. D. (2007). Clinical outcomes of allograft versus autograft in anterior cruciate ligament reconstruction. Clinics in Sports Medicine, 26 (4), 661-681.
BlueCross BlueShield of Tennessee network physicians. December 2002.
Busam, M. L., Rue, J. H., & Bach, B. R. (2007). Fresh-frozen allograft anterior cruciate ligament reconstruction. Clinics in Sports Medicine, 26 (4), 607-623.
Carey, J. L., Dunn, W. R., Dahm, D. L., Zeger, S L., & Spindler, K. P. (2009). A systematic review of anterior cruciate ligament reconstruction with autograft compared with allograft. The Journal of Bone and Joint Surgery, 91 (9), 2242-2250.
Cohen, S. B., & Sekiya, J. K. (2007). Allograft safety in anterior cruciate ligament reconstruction. Clinics in Sports Medicine, 26 (4), 597-605.
Edgar, C. M., Zimmer, S., Kakar, S., Jones, H., & Schepsis, A. A. (2008). Prospective comparison of auto and allograft hamstring tendon constructs for ACL reconstruction. Clinical Orthopedics and Related Research, 466 (9), 2238-2246. (Level 2 Evidence - Independent study)
Gulotta, L. V., & Rodeo, S. A. (2007). Biology of auto graft and allograft healing in anterior cruciate ligament reconstruction. Clinics in Sports Medicine, 26 (4), 509-524.
Jung, H. J., Vangipuram, G., Fisher, M. B., Yang, G., Hsu, S., Bianchi, J, et al. (2011). The effects of multiple freeze-thaw cycles on the biomechanical properties of the human bone-patellar tendon-bone allograft. Journal of Orthopaedic Research, 29 (8), 1193-1198.
Koh, H. S., In, Y., Kong, C. G., Won, H. Y., Kim, K. H., & Lee, J. H. (2010). Factors affecting patients' graft choice in anterior cruciate ligament reconstruction. Clinics in Orthopedic Surgery, 2 (2), 69-75.
Romanini, E., D’Angelo, F., DeMasi, S., Adriani, E., Magaletti, M., Lacorte, E., et al. (2010). Graft selection in arthroscopic anterior cruciate ligament reconstruction. Journal of Orthopaedics and Traumatology, 11 (4), 211-219.
Sun, K., Tian, S., Zhang, J., Xia, C., Zhang, C. & Yu, T. (2009). ACL reconstruction with BPTP autograft and irradiated fresh frozen allograft. Journal of Zhejiang University. Science B, 10 (4), 306-316. (Level 2 Evidence - Independent study)
U. S. Department of Health & Human Services. U. S. Food and Drug Administration. (2008, April). Vaccines, blood & biologics. Guidance for industry certain human cells, tissues, and cellular and tissue-based products (HCT/Ps) recovered from donors who were tested for communicable diseases using pooled specimens or diagnostic tests. Retrieved December 16, 2011 from http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Tissue/ucm062596.pdf.
U. S. Department of Health & Human Services. Centers for Disease Control and Prevention (CDC). (2006, September). About tissue transplants. Retrieved June 2, 2008 from http://www.cdc.gov/ncidod/dhqp/tissueTransplantsFAQ.html.
ORIGINAL EFFECTIVE DATE: 12/1/2001
MOST RECENT REVIEW DATE: 1/12/2012
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.
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