Shoulder resurfacing arthroplasty - Interventional Procedures Consultation Document
NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE
Interventional procedure consultation document
Shoulder resurfacing arthroplasty
Degenerative disease (such as osteoarthritis and rheumatoid arthritis) can cause pain in the shoulder, particularly when the arm is moved.
Shoulder resurfacing involves joint replacement surgery (arthroplasty). Using open surgery, the end of the upper arm bone is reshaped, a small anchoring hole is drilled into the bone and an artificial shoulder joint is placed onto it.
The National Institute for Health and Clinical Excellence (NICE) is examining shoulder resurfacing arthroplasty and will publish guidance on its safety and efficacy to the NHS in England, Wales, Scotland and Northern Ireland. NICE’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 shoulder resurfacing arthroplasty.
This documentsummarises 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 provisional recommendations
· the identification of factual inaccuracies
· additional relevant evidence, with bibliographic references where possible.
Note that this document is not NICE’s formal guidance on this procedure. The recommendations are provisional and may change after consultation.
The process that NICE 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· The Advisory Committee will then prepare draft guidance which will be the basis for NICE’s guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.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 NICE website (www.nice.org.uk/ipprogrammemanual).
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 give suggestions for how it might be improved. NICE reserves the right to summarise and edit comments received during consultations, or not to publish them at all, where in the reasonable opinion of NICE, the comments are voluminous, publication would be unlawful or publication would otherwise be inappropriate.
Closing date for comments: 22 April 2010
Target date for publication of guidance: July 2010
1 Provisional recommendations
1.1 Current evidence on the safety and efficacy of shoulder resurfacing arthroplasty is adequate to support the use of this procedure provided that normal arrangements are in place for clinical governance, consent and audit.
2 The procedure
2.1 Indications and current treatments
2.1.1 Patients with shoulder joint disease may have joint pain accompanied by functional limitation and a reduced quality of life. The humeral head may degenerate as a result of a range of conditions, most commonly osteoarthritis, rheumatoid arthritis or avascular necrosis. The whole or only part of the articular surface of the humeral head may be affected.
2.1.2 Depending on the underlying condition, conservative treatment may include physical therapy, pharmacological treatments (including pain relief and topical or oral non-steroidal anti-inflammatory drugs) or corticosteroid injections. Patients refractory to these treatments may need surgery: either shoulder arthroplasty using a stemmed humeral head prosthesis, or fusion of the joint.
2.2 Outline of the procedure
2.2.1 The aim of shoulder resurfacing arthroplasty is to replace only the damaged joint surfaces, with minimal bone resection.
2.2.2 The procedure is carried out with the patient under general anaesthesia and in a semi-upright position. Either a deltopectoral or anterosuperior approach may be used. The deltoid muscle is split to expose the surface of the humeral head, which is reamed to restore its shape. A hole is drilled for the central anchoring peg of the resurfacing prosthesis.
2.2.3 The peg of the prosthesis is inserted into the drilled hole and morcellised bone or cement is used to aid fixation of the articular prosthesis which may cover the whole or part of the humeral head. A prosthesis may be used to cover the glenoid surface of the scapula if necessary. The shoulder joint is reduced and the wound is closed.
2.2.4 Various devices can be used for this procedure.
| Sections 2.3 and 2.4 describe efficacy and safety outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the overview, available at www.nice.org.uk/IP805overview. |
2.3 Efficacy
2.3.1 A case series of 69 patients (79 shoulders: 37 treated by resurfacing, 42 treated by resurfacing plus glenoid component) reported that mean shoulder function (measured using the Constant-Murley shoulder scale [100-point scale; higher scores better]) improved from 40% of predicted at baseline to 91% at 4.4-year follow‑up in patients treated by articular resurfacing only and from 34% at baseline to 94% at 7.6-year follow-up in patients treated by resurfacing plus a glenoid component.
2.3.2 A non-randomised controlled trial of 44 patients reported no difference in the mean change in shoulder function (using the Constant-Murley shoulder scale) from baseline to 12-month follow-up in patients treated by shoulder resurfacing arthroplasty (8.1 points) compared with patients treated by total shoulder arthroplasty (8.5 points) (p = 0.356). A case series of 94 patients (103 shoulders) reported that mean shoulder function (using the Constant-Murley shoulder scale) improved from 24% of predicted at baseline to 75% of predicted at 6.8-year follow-up (p < 0.001).
2.3.3 Revision surgery (for stemmed humeral prosthesis) was reported in 6% (6/94) of shoulders at 6.8-year follow-up in the case series of 94 patients (103 shoulders). Revision because of persistent pain in 1 of 75 shoulders was reported at a mean follow-up of 6.5 years in the case series of 62 patients (75 shoulders).
2.3.4 The case series of 69 patients (79 shoulders) reported that mean shoulder pain improved from 3.9 points at baseline to 12 points at 4.4-year follow-up in patients treated by shoulder resurfacing arthroplasty, and from 2.1 points to 14 points at 7.6-year follow-up in patients treated by resurfacing plus glenoid component. A case series of 70 patients (84 shoulders) reported that, of 62 patients followed up, the percentage with severe pain reduced from 93% at baseline to 6% at a mean of 4.2-years
2.3.5 A non-randomised controlled trial of 44 patients reported that, of the 22 patients treated by shoulder resurfacing arthroplasty, 2 needed conversion to total shoulder arthroplasty, 1 because of glenoidal erosion and 1 because of persistent pain, at 7 and 9 months respectively.
2.3.6 A case series of 62 patients (75 shoulders) reported that 96% of shoulders were rated as ‘much better’ or ‘better’ (not otherwise described; absolute figures not stated) at 6.5-year follow-up.
2.3.7 Case series of 70 patients (84 shoulders) and 69 patients (79 shoulders) reported that no patient treated by shoulder resurfacing arthroplasty needed a revision procedure at follow-up of 4.2 and 4.4 years respectively.
2.3.8 The Specialist Advisers listed key efficacy outcomes as relief of pain, range of motion, quality of life, and the rate of revision procedures.
2.4 Safety
2.4.1 Removal of the prosthesis and fusion was reported in 2% (2/94) of shoulders at 6.8 year follow-up (1 because of infection and 1 because of instability) in the case series of 94 patients (103 shoulders).
2.4.2 Myositis ossificans causing almost complete ankylosis was reported in 1 patient in a case series of 94 patients at 6.8-year follow-up. The patient had had an initial diagnosis of septic arthritis and extensive previous surgery.
2.4.3 The Specialist Advisers listed adverse events seen or reported in the literature to include loosening of the prosthesis, impingement, and overstuffing during implant if the prosthesis had been incorrectly sized. They considered theoretical adverse events to include infection, nerve injury, deep vein thrombosis, fracture, failure needing revision, and stiffness.
3 Further information
3.1 For related NICE guidance see www.nice.org.uk
Bruce Campbell
Chairman, Interventional Procedures Advisory Committee
March 2010
Personal data will not be posted on the NICE website. In accordance with the Data Protection Act names will be anonymised, other than in circumstances where explicit permission has been given.
It is the responsibility of consultees to accurately cite academic work in order that they can be validated.
This page was last updated: 27 July 2010