A randomised controlled trial comparing the scarf osteotomy and the lapidus procedure in the treatment of hallux valgus associated with metatarsus primus varus
| ISRCTN | ISRCTN81616953 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81616953 |
| Protocol serial number | N0544093617 - PROJ 10/01/2001 |
| Sponsor | Department of Health (UK) |
| Funder | Cambridge Consortium - Addenbrooke's Hospital (UK) |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 19/08/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
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 Andrew HN Robinson
Scientific
Scientific
Box No 37
Department of Orthopaedic Surgery
Addenbrooke's Hospital
Cambridge
CB2 2QQ
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A randomised controlled trial comparing the scarf osteotomy and the lapidus procedure in the treatment of hallux valgus associated with metatarsus primus varus |
| Study objectives | Fusion versus osteotomy for the treatment of primary hallux valgus |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Surgery: Osteotomy |
| Intervention | Patients with metatarsus primus varus and hallux valgus who are having surgical correction will be randomised into having either an osteotomy of the first metatarsal or a fusion of the first tarsometatarsal joint. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Osteotomy |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 22/01/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Key inclusion criteria | Not provided at time of registration |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 22/01/2001 |
| Date of final enrolment | 22/01/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Addenbrooke's Hospital
Cambridge
CB2 2QQ
United Kingdom
CB2 2QQ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
