Unicondylar Interpositional Spacer for the Treatment of Osteoarthritis
DESCRIPTION
Unicondylar interpositional spacers are U-shaped metallic implants that do not require any bone resection or mechanical fixation (e.g., cement, screws) due to being self-centering in the knee. Following arthroscopic debridement and resection of the meniscus, the device is inserted into the joint space above the affected tibial plateau, resting within the boundaries of the resected meniscus. The femur then articulates against the curved surface of the device.
The unicondylar interpositional spacer (e.g., the UniSpacer® Knee System, the Oti Unicondular Interpositional Spacer, the Orthoglide Medical Knee Implant, Knee Interpositional Mini-Repair System) have been proposed for knee joint repair due to conditions such as early-stage osteoarthritis.
POLICY
Unicondylar interpositional spacer for the treatment of osteoarthritis is considered investigational.
See also: Unicompartmental Knee Replacement
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
Well-designed studies in peer-reviewed journals regarding this technology are lacking. Comparative studies of this technology to current medical (i. e., analgesics, antiinflammatory medications) or surgical (i.e., osteotomy, total joint replacement) treatments are not available. Long-term studies are not yet available to establish the safety and efficacy of this technology, especially whether the technology may postpone or prevent the need for total knee joint replacement.
SOURCES
American Academy of Orthopaedic Surgeons. (2008, December). Treatment of osteoarthritis (OA) of the knee recommendation summary. Retrieved December 14, 2010 from http://www.aaos.org/research/guidelines/OAKrecommendations.pdf.
Bailie, A. G., Lewis, P. L., Brumby, S. A., Roy, S., Paterson, R. S., & Campbell, D. G. (2008). The Unispacer knee implant: Early clinical results. The Journal of Bone and Joint Surgery, 90 (4), 446-450. (Level 3 Evidence - Independent study)
BlueCross BlueShield Association. Medical Policy Reference Manual. (9:2009). Unicondylar interpositional spacer as a treatment of unicompartmental arthritis of the knee (7.01.88). Retrieved December 14, 2010 from BlueWeb.
National Guideline Clearinghouse. (2008). American Academy of Orthopaedic Surgeons treatment of osteoarthritis of the knee (non-arthroplasty). Retrieved December 14, 2010 from http://www.guidelines.gov.
National Institute for Health and Clinical Excellence (NICE). (2009, September). Individually magnetic resonance imaging-designed unicompartmental interpositional implant insertion for osteoarthritis of the knee. Retrieved December 14, 2010 from http://www.nice.org.uk/nicemedia/live/12079/45466/45466.pdf.
Richmond, J. C. (2008). Surgery for osteoarthritis of the knee. Rheumatic Disease Clinics of North America, 34 (3), 815-825.
U. S. Food and Drug Administration. (2006, February). Center for Devices and Radiological Health. 501(k) notification K053094. Retrieved December 14, 2010 from http://www.accessdata.fda.gov/cdrh_docs/pdf5/K053094.pdf.
U. S. Food and Drug Administration. (2003, December). Center for Devices and Radiological Health. 501(k) notification K033242. Retrieved December 14, 2010 from http://www.accessdata.fda.gov/cdrh_docs/pdf3/k033242.pdf.
ORIGINAL EFFECTIVE DATE: 6/9/2007
MOST RECENT REVIEW DATE: 1/13/2011
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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