A randomised comparison of three incisions for frontozygomatic (FZ) fracture fixation
| ISRCTN | ISRCTN67230432 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN67230432 |
| Secondary identifying numbers | N0436118104 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 16/08/2012
- 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 PJ McCann
Scientific
Scientific
Department of Oral & Maxillofacial Surgery
Leeds Dental Institute
Clarendon Way
The Worsley Building
Leeds
LS2 9LU
United Kingdom
| Phone | +44 (0)113 233 6219 |
|---|
Study information
| Study design | Randomised controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | To assess the three surgical approaches to the FZ region in terms of adequacy of surgical access, level of difficulty, duration of procedure and level of scarring. To determine which incision gives best cosmetic result for our patients. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Frontozygomatic (FZ) fracture fixation |
| Intervention | Randomised controlled trial. Random allocation to: 1. Incision 1 2. Incision 2 3. Incision 3 |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. Ease of surgery 2. Duration of surgery 3. Improved access surgically 4. Cosmetic outcome of surgery |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 30/08/2002 |
| Completion date | 28/02/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | Patients are self selected by their injury. Fractures requiring operation are included in the trial. |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 30/08/2002 |
| Date of final enrolment | 28/02/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Oral & Maxillofacial Surgery
Leeds
LS2 9LU
United Kingdom
LS2 9LU
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Hospital/treatment centre
Leeds Teaching Hospitals NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
