Nail Versus Sliding Hip Screw for Trochanteric Hip Fractures

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03172923
Study type	Interventional
Source	Peterborough and Stamford Hospitals NHS Foundation Trust
Contact
Status	Completed
Phase	N/A
Start date	October 8, 2010
Completion date	September 1, 2017

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.