Condition category
Injury, Occupational Diseases, Poisoning
Date applied
26/03/2009
Date assigned
07/04/2009
Last edited
07/04/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Timothy Chesser

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

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

Acronym

Study hypothesis

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

South West Local Research Ethics Committee approved on the 12th May 2003 (ref: Frenchay LREC/2003/20)

Study design

Single centre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/04/2003

Overall trial end date

01/04/2006

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

320

Participant exclusion criteria

1. Pathological fractures
2. Previous proximal femoral fractures
3. Decision of the admitting physician

Recruitment start date

01/04/2003

Recruitment end date

01/04/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Trauma and Orthopaedics
Bristol
BS16 1JE
United Kingdom

Sponsor information

Organisation

North Bristol NHS Trust (UK)

Sponsor details

Frenchay Hospital
Frenchay Park Road
Frenchay
Bristol
BS16 1JE
United Kingdom

Sponsor type

Government

Website

http://www.nbt.nhs.uk/

Funders

Funder type

Government

Funder name

North Bristol NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20360500

Publication citations

  1. Results

    Barton TM, Gleeson R, Topliss C, Greenwood R, Harries WJ, Chesser TJ, A comparison of the long gamma nail with the sliding hip screw for the treatment of AO/OTA 31-A2 fractures of the proximal part of the femur: a prospective randomized trial., J Bone Joint Surg Am, 2010, 92, 4, 792-798, doi: 10.2106/JBJS.I.00508.

Additional files

Editorial Notes