Condition category
Musculoskeletal Diseases
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
06/03/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 below 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 measures

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

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

Avon Orthopaedic Centre
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

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

North Bristol NHS Trust

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes