Surgical correction of hallux valgus using minimal access techniques (interventional procedures consultation)

NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE

Interventional procedure consultation document

Surgical correction of hallux valgus using minimal access techniques

Hallux valgus is a deformity of the big toe. The big toe tilts outwards, crowding the smaller toes, and a bony lump (called a bunion) appears on the inside of the foot.

Under local or general anaesthesia, one or more small cuts are made to insert bone-cutting instruments. These are used to remove the bunion and to divide one or more of the bones of the front of the foot. The divided bones may need to be stabilised with wires, screws or plates. The aim is to correct the tilting of the big toe. The operation is monitored by X-rays or an endoscope (a telescope for looking inside the body). Compared with standard (open) surgery, this procedure uses smaller cuts to the foot and X-rays or endoscopy to see inside the foot.

The National Institute for Health and Clinical Excellence (NICE) is examining surgical correction of hallux valgus using minimal access techniques 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 surgical correction of hallux valgus using minimal access techniques.

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 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  • The Advisory Committee will then prepare draft guidance which will be the basis for NICE’s guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.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: 18 November 2009

Target date for publication of guidance: February 2010

 

1       Provisional recommendations

1.1    Current evidence on the efficacy of surgical correction of hallux valgus using minimal access techniques is limited and inconsistent: in addition, it relates to a range of different surgical techniques. The evidence on safety is inadequate. Therefore this procedure should only be used with special arrangements for clinical governance, consent and audit or research.

1.2    Clinicians wishing to undertake surgical correction of hallux valgus using minimal access techniques should take the following actions.

  • Inform the clinical governance leads in their Trusts.
  • Ensure that patients and their carers understand the uncertainty about the procedure’s safety and efficacy and provide them with clear written information. In addition, the use of NICE’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 surgical correction of hallux valgus using minimal access techniques (see section 3.1).

1.3    Further research should compare clearly described minimal access procedures with well defined modern forms of osteotomy. Both objective and functional outcome measures should be reported, together with measurements of pain relief and patient satisfaction, including cosmesis. All adverse events should be described.

1.4    NICE may review this procedure on publication of further evidence.

2       The procedure

2.1    Indications and current treatments

2.1.1 In hallux valgus the big toe is deviated towards the other toes and a bony protrusion (a bunion) is formed on the inner foot. There may be damage to the skin over the bunion, pain when walking, cosmetic concerns, and difficulty with footwear.

2.1.2 Conservative treatment may include footwear modification, and use of insoles or toe spacers. Common surgical treatment options involve different types of first metatarsal osteotomy.

2.2    Outline of the procedure

2.2.1 Surgical correction of hallux valgus using minimal access techniques is carried out with the patient under local or general anaesthesia and with X-ray or endoscopic monitoring. One or more small incisions are made close to the hallux metatarsophalangeal joint. The bunion is removed and the metatarsal is divided surgically. The bone fragments may be stabilised using plates, screws or wires. A dressing or plaster may be used to support the foot in the corrected position until the divided bone heals.

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/IP782overview

 

2.3    Efficacy

2.3.1 The evidence relates to studies that varied in osteotomy technique (in relation to the location, shape and fixation of the osteotomy, and in the methods of visualisation or guidance). Where bone fixation was undertaken, it was usually with Kirschner wires, but use of plates and screws was also reported.

2.3.2 Recurrence of hallux valgus was reported in 2% (2/94) (both required revision) and 1% (1/118) of feet (treatment not described) and 3% of patients (treatment not described) in case series of 83 patients (94 feet), 82 patients (118 feet) and 83 patients (90 feet) respectively (timing of events not stated).

2.3.3 In a case series of 204 patients (301 feet), 83 reported preoperative pain. Of these, 84% (70/83) reported no pain after the operation, 8% (7/83) had decreased pain and 1% (1/83) had increased pain (mean follow-up 8.3 months). The series of 64 patients reported that 95% (61/64) of patients were pain free at a mean follow-up of 9 years.

2.3.4 Case series of 204, 83, 15 and 13 patients reported postoperative decreases in mean hallux angle from 26° to 7.5° (p < 0.05), 33° to 14° (p < 0.05) 32° to 14.1° (p = 0.04), and 25° to 12° (p < 0.0001) at mean follow-up of between 6 weeks and 30.5 months.

2.3.5 The case series of 204 patients (301 feet) reported that 74% (61/83) of survey respondents were very pleased with the procedure, 12% (10/83) were somewhat pleased, 4% (3/83) were not satisfied and 4% (3/83) regretted having had surgery (mean follow-up 8.3 months).

2.3.6 The Specialist Advisers regarded this procedure as novel and of uncertain efficacy. They listed key efficacy outcomes as improvement in pain and deformity, patient satisfaction, radiographic correction of deformity and pedobarography (foot pressure measurement).

2.4    Safety

2.4.1 Deep infection at the osteotomy site was reported in 1 patient (treated by intravenous antibiotics and resolved within 2 weeks) in the case series of 82 patients; 1 patient (Kirschner wire removed after 3 weeks and infection resolved) in the series of 31 patients; and in 4% (4/98) of feet in the series of 64 patients (98 feet).

2.4.2 Osteonecrosis was reported in 8% (1/13) of patients in the case series of 13 patients (13 feet) (timing of event not stated).

2.4.3 Delayed union was reported in 1% (4/301) of feet in the case series of 204 patients (301 feet) (at mean 8.3 month follow-up).  The series of 13 patients reported non-union (with no radiographic evidence of healing at 27 weeks) in 8% (1/13) of patients and dorsal malunion in 69%(9/13) of patients postoperatively (timing of events not stated).

2.4.4 Postoperative hallux varus was reported in 0.3% (1/301) (not otherwise described) and 1% (1/94) (1 year after surgery, treated by extensor hallicus longus transfer) of feet in case series of 204 (301 feet) and 83 (94 feet) patients respectively.

2.4.5 Stress fracture of the second metatarsal was reported in 2% (7/301) of patients in the case series of 204 patients (301 feet) (timing of events not stated).

2.4.6 Specialist Advisers expressed concerns about the safety of this procedure. They listed possible adverse events as nerve injury including complex regional pain syndrome, toe stiffness, skin necrosis, osteomyelitis, deep vein thrombosis, tendon injury, removal of screw fixation, recurrent deformity, fracture, tender scars and skin sensitivity. They considered theoretical adverse events to include burning soft tissue, damage to foot blood vessels, inflammatory reaction to bone debris, and first metatarsal malpositioning, shortening or necrosis.

3     Further information

3.1 This guidance requires that clinicians undertaking the procedure make special arrangements for audit. NICE 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 For related NICE guidance see www.nice.org.uk.

 

Bruce Campbell
Chairman, Interventional Procedures Advisory Committee
October 2009

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: 30 March 2010