Total wrist replacement (interventional procedures consultation)

NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE

Interventional Procedure Consultation Document

Total wrist replacement

Arthritis causes swelling and damage to the cartilage and bone around the joints, including the wrist. If drugs are unable to relieve the pain and improve the range of movement of the affected joints, surgery may be needed. Total wrist replacement aims to create an artificial wrist joint consisting of metal implants attached to the end of the arm and to the hand, separated by a spacer to allow movement of the hand.


The National Institute for Health and Clinical Excellence is examining total wrist replacement and will publish guidance on its safety and efficacy to the NHS in England, Wales, Scotland and Northern Ireland. The Institute's Interventional Procedures Advisory Committee has considered the available evidence and the views of Specialist Advisers, who are consultants with knowledge of the procedure. The Advisory Committee has made provisional recommendations about total wrist replacement.

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 recommendations
  • 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  • The Advisory Committee will then prepare draft guidance which will be the basis for the Institute's guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.

For further details, see the Interventional Procedures Programme manual, which is available from the Institute's website (www.nice.org.uk/ipprocessmanual).

NICE is committed to promoting through its guidance race and disability equality and equality between men and women, and to eliminating all forms of discrimination. One of the ways we do this is by trying to involve as wide a range of people and interest groups as possible in the development of our guidance on interventional procedures. In particular, we aim to encourage people and organisations from groups in the population who might not normally comment on our guidance to do so. We also ask consultees to highlight any ways in which draft guidance fails to promote equality or tackle discrimination and how it might be improved.

Closing date for comments: 23 May 2008
Target date for publication of guidance: August 2008


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

 

1 Provisional recommendations
1.1 There is evidence that total wrist replacement relieves pain, but this is based on small numbers of patients and there is insufficient evidence of its efficacy in the long term. The procedure is associated with a risk of the recognised complications of prosthetic joint replacement. Therefore total wrist replacement should only be used with special arrangements for clinical governance, consent and audit or research.
1.2

Clinicians wishing to undertake total wrist replacement should take the following actions.

  • Inform the clinical governance leads in their Trusts.
  • Ensure that patients understand the possible alternatives to total wrist replacement and the uncertainty about its efficacy in the long term, such that further surgery may be required, including fusion of the wrist joint. They should provide them with clear written information. In addition, the use of the Institute's information for patients ('Understanding NICE guidance') is recommended (available from www.nice.org.uk/IPGXXXpublicinfo). [[details to be completed at publication]]
  • Audit and review clinical outcomes of all patients having total wrist replacement (see section 3.1).
1.3 This procedure should be undertaken only on carefully selected patients, by surgeons with special expertise in the hand and wrist.
1.4 Further publication of safety and efficacy outcomes will be useful. The Institute may review the procedure upon publication of further evidence.
   
2 The procedure
2.1 Indications and current treatments
2.1.1 Wrist arthritis can result from rheumatoid or osteoarthritis, trauma or sepsis. It can cause pain, stiffness and swelling.
2.1.2 Conservative management includes the use of analgesics, non-steroidal anti-inflammatory drugs, disease-modifying antirheumatic drugs or steroid medication. If these are inadequate, surgical treatments such as proximal row carpectomy, limited or partial carpal fusion, or total wrist athrodesis can be used.    
2.2 Outline of the procedure
2.2.1 Normal wrist motion occurs by a complex interaction of articulations that involve the radius, ulna and the carpal bones. Total wrist replacement aims to create a stable, pain-free joint with a functional range of movement.
2.2.2 The procedure is performed under either general or regional anaesthesia with the use of a tourniquet. A dorsal approach is made to the wrist and bone is removed from both sides of the joint using jigs. The prosthetic components are then impacted into the bones and may be further fixed with screws before the bearing surface is attached onto the ends of these components. Fluoroscopy is sometimes used to confirm positions of the implants.    
Sections 2.3 and 2.4 describe efficacy and safety outcomes which were available in the published literature and which the Committee considered as part of the evidence about this procedure. For more details, refer to the Sources of evidence.    
2.3 Efficacy
2.3.1 A non-randomised controlled trial of 51 patients comparing wrist implant (27 wrists) with arthrodesis (24 wrists) reported no statistically significant difference in wrist function (measured by Disabilities of the arm, shoulder and hand [DASH] and Patient-related wrist evaluation [PRWE] questionnaires). In a case series of 19 patients (22 wrists), mean DASH score improved from 46.0 points at baseline to 32.1 points at 12-month follow-up (p < 0.05).
2.3.2 A case series of 30 patients (32 wrists) reported a significant improvement in range of motion for all aspects, apart from radial deviation, after 20 months. A case series of 27 patients (29 wrists) reported improvement in some movements  but not others at 4-year follow-up. Pain was significantly improved (p < 0.002).
2.3.3 A case series of 25 patients (28 wrists) reported pain as absent in 72% (18/25), moderate in 20% (5/25), and severe in 8% (2/25) 47 months after the wrist implant. Another case series reported pain relief in all 25 patients, although 20% (5/25) reported mild discomfort on the ulnar side (follow-up period not stated).    
2.3.4 In the case series of 27 patients, 89% (24/27) reported a marked improvement in their daily lives and upper extremity function after total wrist replacement.    
2.3.5 The Specialist Advisers considered key efficacy outcomes to include long-term pain relief, range of motion, functional movement and prosthesis survival.    
2.4 Safety
2.4.1 The non-randomised controlled trial of 51 patients reported superficial wound complications in 22% (6/27), joint instability in 15% (4/27), and persistent paraesthesia in 4% (1/27) of patients.
2.4.2 In four case series, wrist implant dislocation occurred in 16% (5/32), 14% (3/22), 0% (0/25) and 0% (0/28) of wrists. Joint loosening (usually based on radiographic assessment) was reported in 16% (5/32), 10% (3/29), 0% (0/25), and 0% (0/28).
2.4.3 In the non-randomised study, hardware-related fracture occurred in 0% (0/27) and 4% (1/24) in the implant and arthrodesis groups, respectively. In the case series, implant complications or errors in implantation occurred in 32% (8/25), 19% (5/27) and 12% (3/25) of patients, and in 27% (6/22) of wrists.    
2.4.4 The Specialist Advisers considered key safety outcomes to include rates of infection, dislocation, loosening, stiffness and neurovascular complications. Additional theoretical events include tendon rupture, periprosthetic fracture, complex regional pain syndrome, poor fixation of the carpal component and implant failure.    
2.5 Other comments    
2.5.1 The Committee saw evidence on several implants, some of which have been withdrawn. The implant design continues to evolve.    
2.5.2 Most of the evidence seen by the Committee related to patients with rheumatoid arthritis.    
   
3 Further information    
3.1 This guidance requires that clinicians undertaking the procedure make special arrangements for audit. The Institute has identified relevant audit criteria and is developing an audit tool (which is for use at local discretion), which will be available when the guidance is published.    
3.2 The Institute has published interventional procedures guidance on artificial metacarpophalageal and interphalangeal joint replacement for end-stage arthritis (www.nice.org.uk/IPG110) and artificial trapeziometacarpal joint replacement for end-stage osteoarthritis (www.nice.org.uk/IPG111). A clinical guideline on the care and management of adults with osteoporosis (www.nice.org.uk/CG059) has also been published.    

Bruce Campbell
Chairman, Interventional Procedures Advisory Committee
April 2008

Appendix: Sources of evidence
 
The evidence considered by the Interventional Procedures Advisory Committee is described in the overview, available at: www.nice.org.uk/ip494overview.

This page was last updated: 30 March 2010