Colles Fracture Brace prospective randomised study
| ISRCTN | ISRCTN45883421 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45883421 |
| Protocol serial number | 07/S0801/116 |
| Sponsor | NHS Grampian (UK) |
| Funder | Local funding from endowments (derek.angus@nhs.net) |
- Submission date
- 27/10/2009
- Registration date
- 07/12/2009
- Last edited
- 02/10/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
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
Prof Douglas Wardlaw
Scientific
Scientific
Orthopaedic Department
Woodend Hospital
Eday Road
Aberdeen
AB15 6XS
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 | Colles Fracture Brace prospective randomised study |
| Study acronym | CFB Study |
| Study objectives | Treatment by a fracture brace will have a better outcome than standard care. |
| Ethics approval(s) | North of Scotland Research Ethics Committee, 26/02/2008, ref: 07/S0801/116 |
| Health condition(s) or problem(s) studied | Colles fracture |
| Intervention | Application of plaster of paris (POP) cast, brace or surgery. Total duration of follow-up: 2 years |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Clinical and radiological outcome at 6 months |
| Key secondary outcome measure(s) |
Clinical outcome at 2 years |
| Completion date | 16/05/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 340 |
| Key inclusion criteria | 1. Both males and females, aged 18 and over 2. Colles fracture requiring treatment |
| Key exclusion criteria | 1. Compared fracture 2. Previous fracture 3. Unable to give informed consent |
| Date of first enrolment | 16/11/2009 |
| Date of final enrolment | 16/05/2012 |
Locations
Countries of recruitment
- United Kingdom
- Scotland
Study participating centre
Woodend Hospital
Aberdeen
AB15 6XS
United Kingdom
AB15 6XS
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 |
Editorial Notes
02/10/2017: No publications found, verifying study status with principal investigator.
