Assessment of patients with midshaft clavicular fractures randomised to either conservative or operative treatment
| ISRCTN | ISRCTN57483251 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN57483251 |
| Protocol serial number | N0188119749 |
| Sponsor | Department of Health (UK) |
| Funder | Lancashire Teaching Hospitals NHS Trust (UK) |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 27/10/2015
- 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
Mr SA Khan
Scientific
Scientific
Consultant Orthopaedic Surgeon
Royal Preston Hospital
Sharoe Green Lane North
Fulwood
Preston
PR2 9HT
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 | Assessment of patients with midshaft clavicular fractures randomised to either conservative or operative treatment |
| Study objectives | To assess which type of treatment is superior in terms of patient satisfaction (SF 12) and function (Visual Analogue Scale [VAS] and Constant scoring system). |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Injury, Occupational Diseases, Poisoning: Clavicular fracture |
| Intervention | Randomised to either conservative or operative treatment |
| Intervention type | Other |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/05/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 40 |
| Key inclusion criteria | Patients with midshaft clavicular fractures |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 12/12/2002 |
| Date of final enrolment | 01/05/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Royal Preston Hospital
Preston
PR2 9HT
United Kingdom
PR2 9HT
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 |
