Long gamma nail versus sliding hip screw for the treatment of unstable pertrochanteric hip fractures

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mr Timothy Chesser
Scientific

Department of Trauma and Orthopaedics
Frenchay Hospital
Frenchay Park Road
Frenchay
Bristol
BS16 1JE
United Kingdom

Primary study design	Interventional
Study design	Single centre randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	Re-operation within the first post-operative year.
Key secondary outcome measure(s)	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
Completion date	01/04/2006

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

Department of Trauma and Orthopaedics

Bristol
BS16 1JE
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2010		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes