DESCRIPTION
Pyrocarbon metacarpophalangeal and proximal interphalangeal joint implants are intended for the treatment of symptomatic joint disease. The implants consist of two-piece artificial finger joints. One piece has a ball shaped end and stem. The other piece has a cup shaped receptacle and stem. These two pieces are intended to replace the articulating surfaces of the metacarpophalangeal and proximal interphalangeal joints. The stem of each piece is surgically implanted into the shaft of the finger bone with bone cement.
This policy is specific to pyrocarbon implants and does not address other types of metacarpophalangeal or interphalangeal joint implants.
POLICY
Pyrocarbon metacarpophalangeal and proximal interphalangeal joint implants for the treatment of symptomatic joint disease is considered investigational.
ADDITIONAL INFORMATION
Published scientific evidence in the form of well-designed studies in peer-review journals regarding the clinical utility of pyrocarbon metacarpophalangeal and proximal interphalangeal joint implants is lacking.
Long-term studies regarding the safety and effectiveness of these implants are not available.
Studies including direct comparisons with other joint prostheses are not available.
Subgroup analyses for defining patient selection criteria are not available.
SOURCES
Medical Advisory Secretariat, Ontario Ministry of Health and Long-Term Care. (2004, March). Pyrocarbon finger joint implant. Retrieved August 3, 2009 from https://ozone.scholarsportal.info/bitstream/1873/3691/1/245277.pdf.
National Institute for Health and Clinical Excellence (NICE). (2005, February). Artificial metacarpophalangeal and interphalangeal joint replacement for end-stage arthritis. Retrieved August 3, 2009 from http://www.nice.org.uk/nicemedia/pdf/ip/IPG110guidance.pdf.
Polatsch, D. B. & Paksima, N. (2006). Basal joint arthritis: diagnosis and treatment. Bulletin of the NYU Hospital for Joint Diseases, 64 (3-4), 178-184.
Skie, M., Gove, N., & Ciocanel, D. (2007). Intraoperative fracture of a pyrocarbon PIP total joint - A case report. Hand, 2 (3), 90-93.
Squitieri, L., & Chung, K. C. (2008). A systematic review of outcomes and complications of vascularized toe joint transfer, silicone arthroplasty, and PyroCarbon arthroplasty for posttraumatic joint reconstruction of the finger. Plastic Reconstructive Surgery, 121 (5), 1697-16707.
U. S. Food and Drug Administration. (2006, May). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K060386. Retrieved May 29, 2009 from http://www.accessdata.fda.gov/cdrh_docs/pdf6/K060386.pdf.
U. S. Food and Drug Administration. (2002, March). Center for Devices and Radiological Health. Device Approvals and Clearances. H010005. Retrieved August 3, 2009 from http://www.accessdata.fda.gov/cdrh_docs/pdf/H010005b.pdf.
ORIGINAL EFFECTIVE DATE: 5/13/2006
MOST RECENT REVIEW DATE: 9/10/2009
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.