Open reduction and internal fixation (ORIF) versus conservative treatment of high energy clavicle fractures
| ISRCTN | ISRCTN00825817 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN00825817 |
| Protocol serial number | N0188095539 |
| Sponsor | Department of Health |
| Funder | Lancashire Teaching Hospitals NHS Trust (UK) |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 02/02/2017
- 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
Mr Steve Bale
Scientific
Scientific
Orthopaedics
Lancashire Teaching Hospitals NHS Trust
Preston
PR2 9HT
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Open reduction and internal fixation (ORIF) versus conservative treatment of high energy clavicle fractures |
| Study objectives | Does early fixation influence outcome? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Injury, Occupational Diseases, Poisoning: Fractures |
| Intervention | Open reduction and internal fixation (ORIF) versus conservative treatment |
| Intervention type | Other |
| Primary outcome measure(s) |
Using shoulder scoring system |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 40 |
| Key inclusion criteria | All patients with high energy clavicle fractures |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/06/1999 |
| Date of final enrolment | 01/12/2006 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Orthopaedics
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 |
Editorial Notes
02/02/2017: No publications found in PubMed, verifying study status with principal investigator.
