Hip Injuries Clinical Trial
Official title:
Randomised Trial of Trochanteric Hip Fractures Treated With Either a Sliding Hip Screw on an Intramedullary Nail
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.
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.
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