The National Institute for Clinical Excellence is examining artificial trapeziometacarpal joint replacement for end-stage osteoarthritis and will publish guidance on its safety and efficacy to the NHS in England, Wales and Scotland. The Institute's Interventional Procedures Advisory Committee has considered the available evidence and the views of Specialist Advisors, who are consultants with knowledge of the procedure. The Advisory Committee has made provisional recommendations about artificial trapeziometacarpal joint replacement for end-stage osteoarthritis.

This document summarises the procedure and sets out the provisional recommendations made by the Advisory Committee. It has been prepared for public consultation. The Advisory Committee particularly welcomes:

• comments on the preliminary recommendation
• the identification of factual inaccuracies
• additional relevant evidence.

Note that this document is not the Institute's formal guidance on this procedure. The recommendations are provisional and may change after consultation.

The process that the Institute will follow after the consultation period ends is as follows:

• The Advisory Committee will meet again to consider the original evidence and its provisional recommendations in the light of the comments received during consultation.
• The Advisory Committee will then prepare draft guidance which will be the basis for the Institute's guidance on the use of the procedure in the NHS in England, Wales and Scotland.

For further details, see the Interventional Procedures Programme manual, which is available from the Institute's website (/proxy/?sourceUrl=http%3a%2f%2fwww.nice.org.uk%2fipprogrammemanual).

Closing date for comments: 23 November 2004

Target date for publication of guidance: February 2005

Note that this document is not the Institute's guidance on this procedure. The recommendations are provisional and may change after consultation.

Current evidence on the safety and efficacy of artificial trapeziometacarpal (TMC) joint replacement for end-stage osteoarthritis appears adequate to support the use of this procedure provided that the normal arrangements are in place for consent, audit and clinical governance.

Most of the evidence was based on a single type of joint prosthesis. The range of prostheses used is continually changing and clinicians are encouraged to submit their results to the appropriate joint replacement registry for evaluation of long-term outcomes of different types of prostheses.

Osteoarthritis of the hand joints is a common condition that deteriorates over time, although the severity of symptoms, rate of deterioration and functional effects are variable. Artificial TMC joints are primarily used to treat the pain of severe end-stage osteoarthritis.

Conservative treatments for osteoarthritis of the hand include anti inflammatory and analgesic medication, and steroid injections. Other treatments include complete joint excision without replacement (also called excision arthroplasty), native graft arthroplasties (in which the patient's own tissue, typically tendons, is interposed in the space left after joint excision) and fusion of joints (arthrodesis).

A general anaesthetic is usually used and a tourniquet is applied to the affected arm to maintain a blood-free operation site. An incision is made over the diseased joint and the tendons are retracted. The joint is removed with an oscillating saw, and a prosthetic joint (typically made of a silicone-based material) is inserted in its place. A splint is applied to the fingers.

The five studies reviewed described a total of 257 patients. In one small randomised controlled trial, comparing silicone prosthesis arthroplasty with tendon arthroplasty, the proportion of satisfied patients was similar in the two groups (80% versus 85%; 12/15 and 11/13 patients, respectively). The mean pain reduction was also similar in both groups of patients. A non-randomised comparative study of 89 patients reported significantly less pain at 12 months in 50 joints treated with a silicone prosthesis arthroplasty, compared with 54 joints treated with sling excision arthroplasty (p < 0.01). Patients in the silicone prosthesis group reported better function for most tasks (statistically significant for being able to carry a milk bottle and taking off the handbrake of a car) but there was no statistically significant difference in patient satisfaction between the two groups. A case series of 58 patients with a mean follow-up of 16 years reported that maximal improvement was achieved at 5 years. A small case series reported that 88% (22/25) of patients had less pain than before the procedure after a mean follow-up of 6.5 years. For more details, refer to the sources of evidence (see Appendix).

The Specialist Advisors considered that the long-term benefits of this procedure need to be compared with the long-term benefits of established procedures such as incision arthroplasty and joint fusion.

Four studies comprising a total of 242 patients reported on safety of the procedure. In 3 studies, between 6% (4/62) and 20% (6/30) of implants had to be removed. The reasons for removal were listed as subluxation, fracture, dislocation, infection, pain, stiffness, and silicone synovitis. One study of 90 patients reported that components loosened in 16% (13/79) of replacement joints after a mean follow-up period of 6 years. Two studies reported that a small number of patients had reflex sympathetic dystrophy after the procedure (3% [2/58] and 4% [1/25] of patients). For more details, refer to the sources of evidence (see Appendix).

The Specialist Advisors considered that the main potential adverse effects include infection, stiffness, nerve injury, silicone synovitis and failure of the joint replacement.

The following document, which summarises the evidence, was considered by the Interventional Procedures Advisory Committee when making its provisional recommendations.

Interventional procedures overview of artificial trapeziometacarpal joint replacement for end-stage osteoarthritis, July 2004

Available from: www.nice.org.uk/ip276overview