Bunion - Clinical trial details 

Recruitment status:

Not recruiting

Primary Sponsor:

Record Provided by the NHSTCT Register - 2007 Update - Department of Health

Recruitment countries:

United Kingdom

Health condition studied:

Musculoskeletal Diseases: Hallux valgus

URL:

Link to the clinical trial website

About the trial

Interventions:

Patients who are on the waiting list for surgery for bunions (hallux valgus) under the care of the 3 North Bristol NHS Trust foot and ankle Consultant surgeons will have an x-ray taken in the clinic. If the x-ray shows a suitable position of the bonesfor one of the 2 operations, and the patient is requesting surgery, then the patient will be invited to participate in the trial. It will be explained by the surgeon listing the patient for surgery. Patients will receive an information sheet explaining the trial. If they consent to enter the trial, then they will be randomised to receive one of the two operations. Patients will be asked to complete a questionnaire with questions concerning pain and activity level. This can be completed by the patient to ensure no bias is introduced. The operation will be performed by their usual surgical team. The postoperative care will be the same regardless of which operation is performed. Patients will be seen at 2 weeks, 6 to 8 weeks, 3 months and 1 year for clinical reviews. X-rays will be performed at 6 to 8 weeks and at 1 year. Patients will be asked to complete a questionnaire at 1 year whilst attending the clinic. This will be the final review. Measurements will be taken from the 1 year x-ray and compared to the pre-surgery x-ray. Patient scores regarding satisfaction, pain, activity levels will be assessed from the questionnaires. Any complications will be recorded as they occur. The review at 1 year has been chosen because by this stage the patient should have achieved the level of symptoms that they could expect long-term after surgery. Results will be analysed using a statistical package (SPSS software).

Key inclusion and exclusion criteria:

• Inclusion criteria: 1. Hallux valgus deformity requiring surgical correction because of discomfort, pain, inability to wear appropriate footwear. 2. X-rays will be measured. The intermetatarsal angle should be between 11 and 18 degrees for inclusion. This range is known as the moderate range and is felt to be suitable for the 2 operations in the trial. An angle greater than this would require a different type of operation.
• Exclusion criteria: 1. Inability to consent - it is non-life or limb threatening surgery, therefore patients should be able to consent to a surgical procedure. 2. Age under 16 - unusual to require surgery at this age, and this would lead to consent issues. 3. Multiple surgery to other toes, foot or ankle - will influence results because shape correction may be due to the other surgical procedures. 4. Distal surgery required - will cause bias because not studying the same deformity and angle correction will be affected. 5. Previous surgery to first metatarsal - more complicated surgery, not comparing same condition

• Age minimum:
• Age maximum:
• Gender:

Primary outcomes:

Intermetatarsal angle correction (degrees)

Secondary outcomes:

Not provided at time of registration

Target sample size:

Approximately 120 participants (60 per treatment group)

Study type:

Interventional

Study design:

Randomised controlled trial

Contacts:

• Name: S White
• Address: Avon Orthopaedic Centre Southmead Hospital
• Phone: +44
• Email: simonpwhite@blueyonder.co.uk
• Affiliation:

Technical details

Scientific title:

Sources of monetary support:

North Bristol NHS Trust

Secondary sponsors:

N/A

Main ID:

ISRCTN20928161

Secondary ID:

N0234179113

Register:

ISRCTN

Date of registration:

28/09/2024

Date of first enrollment:

Jan 2 2006

Last refreshed:

7 June 2024