Long gamma nail versus sliding hip screw for the treatment of unstable pertrochanteric hip fractures
| ISRCTN | ISRCTN79362886 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN79362886 |
| Secondary identifying numbers | N/A |
- Submission date
- 26/03/2009
- Registration date
- 07/04/2009
- Last edited
- 07/04/2010
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Timothy Chesser
Scientific
Scientific
Department of Trauma and Orthopaedics
Frenchay Hospital
Frenchay Park Road
Frenchay
Bristol
BS16 1JE
United Kingdom
Study information
| Study design | Single centre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A prospective randomised controlled trial comparing the long gamma nail with the sliding hip screw for the treatment of unstable pertrochanteric hip fractures |
| Study objectives | There is no difference in outcome between the sliding hip screw and the long gamma nail in the treatment of unstable pertrochanteric hip fractures. |
| Ethics approval(s) | South West Local Research Ethics Committee approved on the 12th May 2003 (ref: Frenchay LREC/2003/20) |
| Health condition(s) or problem(s) studied | Unstable pertrochanteric fractures of the proximal femur |
| Intervention | Patients entered into the trial were randomised to fixation of their proximal femoral fracture by either a sliding hip screw (Omega® II, Stryker, UK) or a long gamma nail (Dyax®, Stryker, UK). Randomisation was via sealed envelopes. Neither participants nor physicians were blinded to treatment. |
| Intervention type | Other |
| Primary outcome measure | Re-operation within the first post-operative year. |
| Secondary outcome measures | 1. Mortality in the first post-operative year 2. Requirement for a blood transfusion within one week of surgery 3. Length of hospital stay 4. Mobility and residency at one year 5. Euroqol EQ-5D at 3, 6 and 12 months post-operation |
| Overall study start date | 01/04/2003 |
| Completion date | 01/04/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 320 |
| Key inclusion criteria | All patients (both males and females) over the age of 18 years admitted to the treating hospital with an unstable pertrochanteric hip fracture. |
| Key exclusion criteria | 1. Pathological fractures 2. Previous proximal femoral fractures 3. Decision of the admitting physician |
| Date of first enrolment | 01/04/2003 |
| Date of final enrolment | 01/04/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Trauma and Orthopaedics
Bristol
BS16 1JE
United Kingdom
BS16 1JE
United Kingdom
Sponsor information
North Bristol NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Frenchay Hospital
Frenchay Park Road
Frenchay
Bristol
BS16 1JE
England
United Kingdom
| Website | http://www.nbt.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/036x6gt55 |
Funders
Funder type
Government
North Bristol 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2010 | Yes | No |
