Nail Versus Sliding Hip Screw for Trochanteric Hip Fractures

The investigators therefore propose to undertake a further randomised controlled trial comparing the sliding hip screw (SHS) with the Targon PFT intramedullary nail. The aim is to see if the summation of the first trial of 600 participants comparing the sliding hip screw with the Targon PF nails, in conjunction with this study of 400 participants with the updated Targon PFT nail produces results that convincingly demonstrate that this particular design of implant is superior to the sliding hip screw. Because of the financial issues involved a cost benefit comparison for the two procedures is planned at the completion of the study.

Primary outcome measures will be regain of walking ability. Secondary outcome measures recorded with include mortality, length of surgery, operative blood loss, blood transfusion, post-operative complications, hospital stay, need for subsequent revision surgery and degree of residual pain.

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Key information

Conditions

Hip Injuries Wounds and Injuries

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

The trial will be run as close to the ideal trial methodology for a randomised trial as specified by the CONSORT statement as possible. This will include secure randomisation, intention to treat analysis, full reporting of outcomes and follow-up by a person who is blinded to the prosthesis used. The trial will follow the code of good clinical practice as specified by the hospital trusts Research and Development Committee.

In Peterborough all hip fracture patients are admitted to the acute trauma ward and transferred to the care of MJP. Those patients that are willing to participant in one of our randomised trials are consented prior to surgery. Treatment follows standard evidence based protocols with follow-up of all patients in a hip fracture clinic. A comprehensive database is maintained for all patients containing both audit and research data. Included in this is a standardised assessment of outcome.

The sliding hip screw used if of a standard design that has been in use at Peterborough for the last fifty years. The intramedullary nails used will be the Targon PFT nail. This nail is very similar to the Targon PF nail used in the earlier trial on this topic. Bases on the results of the previous study and the experience of other users the nail has undergone minor modifications that are primarily aimed at making the nail easier to use with improved instrumentation and also a change to design of the cross screw aimed at reducing the risk of fracture fixation complications occurring.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All patients admitted to Peterborough District Hospital with a trochanteric hip fracture that is to be treated by internal fixation.

Exclusion criteria

Patients who decline to participate
Patients without the capacity to give informed consent
Patients admitted when MJP is not available to supervise treatment
Patients with pathological fractures from Paget's disease of bone secondaries from tumour

Treatment and study plan

sliding hip screw

Device

fixation of the fracture with a sliding hip screw

intramedullary nial

Device

fixation of the fracture with an intramedullary nail

Primary outcomes

regain of mobility

Time frame: one year from injury

regain of walking ability using a standardised mobility score (Parker MJ, Palmer CR. A new mobility score for predicting mortality after hip fracture. J Bone Joint Surg 1993;75-B:797-8.)

Secondary outcomes

mortality

Time frame: at one year from injury

mortality

Sponsors and collaborators

Lead sponsor

Peterborough and Stamford Hospitals NHS Foundation Trust

Other

Registry information

Official study title

Randomised Trial of Trochanteric Hip Fractures Treated With Either a Sliding Hip Screw on an Intramedullary Nail

Important dates

Study start: 2010
Primary completion: 2016
Study completion: 2017
First posted: Jun 1, 2017
Registry last updated: Sep 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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