Randomised controlled trial of Taylor's versus scarf osteotomy for hallux valgus
| ISRCTN | ISRCTN20928161 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN20928161 |
| Secondary identifying numbers | N0234179113 |
- Submission date
- 28/09/2007
- Registration date
- 28/09/2007
- Last edited
- 10/07/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr S White
Scientific
Scientific
Avon Orthopaedic Centre
Southmead Hospital
Bristol
BS10 5NB
United Kingdom
| simonpwhite@blueyonder.co.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Randomised controlled trial of Taylor's versus scarf osteotomy for hallux valgus |
| Study objectives | Is there any difference in the results of surgery between two commonly performed operations for hallux valgus (bunion)? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | Intermetatarsal angle correction (degrees) |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 02/01/2006 |
| Completion date | 02/01/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Approximately 120 participants (60 per treatment group) |
| Key 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. |
| Key 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 |
| Date of first enrolment | 02/01/2006 |
| Date of final enrolment | 02/01/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Southmead Hospital
Bristol
BS10 5NB
United Kingdom
BS10 5NB
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
North Bristol NHS Trust
Government organisation / Local government
Government organisation / Local government
- Alternative name(s)
- NBT
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
10/07/2017: No publications found, verifying study status with principal investigator.
