A multicentre randomised controlled study of primary femoral fixation versus delayed definitive femoral fixation in patients with multiple trauma
| ISRCTN | ISRCTN78578486 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN78578486 |
| Protocol serial number | N0436125527 |
| Sponsor | Department of Health |
| Funder | Leeds Teaching Hospitals NHS Trust (UK) |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 02/08/2016
- 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
Dr P V Giannoudis
Scientific
Scientific
Academic Department of Orthopaedic Surgery
Level 5, Clinical Sciences Building
St James's University Hospital
Beckett Street
Leeds
LS9 7TF
United Kingdom
| Phone | +44 (0)113 206 7068 |
|---|---|
| Peter.Giannoudis@leedsth.nhs.uk |
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 multicentre randomised controlled study of primary femoral fixation versus delayed definitive femoral fixation in patients with multiple trauma |
| Study objectives | This study aims to compare the effects of early primary intramedullary nailing and delayed femoral intramedullary nailing in patients who have sustained a femoral shaft fracture and multiple injuries with an injury severity score of >16. It will be in particular studying the rates of complications such as multi-organ failure and acute respiratory distress syndrome to see if there is a difference in the incidence of these between the two techniques. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Injury, Occupational Diseases, Poisoning: Femoral shaft fracture |
| Intervention | Randomised controlled trial |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Mean ventilation |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/08/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 20 |
| Key inclusion criteria | 10-20 patients who have sustained polytrauma |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 01/08/2002 |
| Date of final enrolment | 01/08/2003 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
St James's University Hospital
Leeds
LS9 7TF
United Kingdom
LS9 7TF
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
02/08/2016: No publications found, verifying study status with principal investigator.
