Surgical correction of hallux valgus using minimal access techniques

# Guidance
Current evidence on the efficacy of surgical correction of hallux valgus using minimal access techniques is limited and inconsistent. In addition, the evidence 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.
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.
Audit and review clinical outcomes of all patients having surgical correction of hallux valgus using minimal access techniques (see section 3.1).
Further research should evaluate clearly described minimal access procedures using 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.
NICE may review this procedure on publication of further evidence.# The procedure

# Indications and current treatments
In hallux valgus the big toe is deviated towards the other toes and a bony protrusion (a bunion) is formed by medial deviation of the first metatarsal phalangeal joint. There may be damage to the skin over the bunion, pain when walking, cosmetic concerns and difficulty with footwear.
Conservative treatment may include footwear modification, and use of insoles or toe spacers. Common surgical treatment options involve different types of first metatarsal osteotomy.

# Outline of the procedure
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.

# Efficacy
The evidence relates to studies that varied in osteotomy technique (regarding 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 were also reported.
Recurrence of hallux valgus was reported in 2% (2/94) and 1% (1/118) of treated feet in case series of 83 and 82 patients respectively (timing of events not stated).
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). A series of 64 patients reported that 95% (61/64) of patients were pain free at a mean follow-up of 9 years.
Case series of 204 and 168 patients reported postoperative decreases in mean hallux angle from 26 to 7.5 (p < 0.05) and 28 to 14 (significance not stated) at mean follow-up of 6 weeks and 31.5 months respectively.
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).
The Specialist Advisers listed key efficacy outcomes as improvement in pain and deformity, patient satisfaction, radiographic correction of deformity and pedobarography (foot pressure measurement).

# Safety
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 a series of 31 patients; and in 4% (4/98) of feet in the series of 64 patients (98 feet).
Osteonecrosis was reported in 8% (1/13) of patients in a case series of 13 patients (13 feet) (timing of event not stated).
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). A case series of 49 patients (59 feet) reported malunion and nonunion in 2 patients each (assessed radiographically at mean follow-up 31.5 months).
Postoperative hallux varus was reported in 0.3% (1/301) (not otherwise described) and 1% (1/94) (1 year after surgery, treated by extensor hallucis longus transfer) of feet in case series of 204 (301 feet) and 83 (94 feet) patients respectively.
Stress fracture of the second metatarsal was reported in 2% (7/301) of feet in the case series of 204 patients (timing of events not stated).
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 fixation screw, 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.# Further information
This guidance requires that clinicians undertaking the procedure make special arrangements for audit. NICE has identified relevant audit criteria and developed audit support (which is for use at local discretion).
For related NICE guidance see our website.

# Information for patients
NICE has produced information on this procedure for patients and carers ('Understanding NICE guidance'). It explains the nature of the procedure and the guidance issued by NICE, and has been written with patient consent in mind.# About this guidance
NICE interventional procedure guidance makes recommendations on the safety and efficacy of the procedure. It does not cover whether or not the NHS should fund a procedure. Funding decisions are taken by local NHS bodies after considering the clinical effectiveness of the procedure and whether it represents value for money for the NHS. It is for healthcare professionals and people using the NHS in England, Wales, Scotland and Northern Ireland, and is endorsed by Healthcare Improvement Scotland for implementation by NHSScotland.
This guidance was developed using the NICE interventional procedure guidance process.
We have produced a summary of this guidance for patients and carers. Tools to help you put the guidance into practice and information about the evidence it is based on are also available.
Changes since publication
January 2012: minor maintenance.
Your responsibility
This guidance represents the views of NICE and was arrived at after careful consideration of the available evidence. Healthcare professionals are expected to take it fully into account when exercising their clinical judgement. This guidance does not, however, override the individual responsibility of healthcare professionals to make appropriate decisions in the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.
Implementation of this guidance is the responsibility of local commissioners and/or providers. Commissioners and providers are reminded that it is their responsibility to implement the guidance, in their local context, in light of their duties to avoid unlawful discrimination and to have regard to promoting equality of opportunity. Nothing in this guidance should be interpreted in a way which would be inconsistent with compliance with those duties.
Copyright
 National Institute for Health and Clinical Excellence 2010. All rights reserved. NICE copyright material can be downloaded for private research and study, and may be reproduced for educational and not-for-profit purposes. No reproduction by or for commercial organisations, or for commercial purposes, is allowed without the written permission of NICE.
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