Contact information
Type
Scientific
Primary contact
Mr S White
ORCID ID
Contact details
Avon Orthopaedic Centre
Southmead Hospital
Bristol
BS10 5NB
United Kingdom
-
simonpwhite@blueyonder.co.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0234179113
Study information
Scientific title
Randomised controlled trial of Taylor's versus scarf osteotomy for hallux valgus
Acronym
Study hypothesis
Is there any difference in the results of surgery between two commonly performed operations for hallux valgus (bunion)?
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Musculoskeletal Diseases: Hallux valgus
Intervention
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 two 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).
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
Intermetatarsal angle correction (degrees)
Secondary outcome measures
Not provided at time of registration
Overall trial start date
02/01/2006
Overall trial end date
02/01/2008
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Approximately 120 participants (60 per treatment group)
Participant 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
Recruitment start date
02/01/2006
Recruitment end date
02/01/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Southmead Hospital
Bristol
BS10 5NB
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
North Bristol NHS Trust
Alternative name(s)
NBT
Funding Body Type
government organisation
Funding Body Subtype
government non-federal
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list