UnknownNot Applicable

Stabilization of Fresh Unilateral Unstable Pertrochanteric Hip Fracture

United Kingdom60 participantsStarted 2016-06

Plain-language summary

This is a preliminary study to establish the issues and potential of the investigators proposed project, which involves recruitment of patients with and without dementia, who have been admitted to hospital following hip fractures. The study will be evaluating the result of treatment of unstable pertrochanteric hip fractures focusing on how soon mobility is restored leading to their independence. These patients would require surgical fixation (not replacement) of their hip fractures. The study will evaluate two methods of fixation of hip fractures treated with either a pin (nail) which is inserted within the cavity of the thigh bone or a hip screw with a plate which is applied on the outer aspect of the thigh bone. The data collected from this study will provide information on whether one method of fixation is better than the other.

Who can participate

Age range55 Years – 95 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 55-95 years * Fresh unstable (AO/OTA type A2) pertrochanteric fracture * If medically fit, patient will undergo surgical fixation within 48 hours of admission. Otherwise, all patients to be recruited must undergo surgery within 7 days of admission * Patient or patient's carer/personal or nominated consultee has provided informed consent/assent to participate in the study * Patient is considered able to complete the study assessment and visit schedule in the opinion of the investigating team Exclusion Criteria: * Unable to ambulate pre-injury, even with walking aids * Unable to undergo surgical fixation within 7 days of admission * Patient is for any reason considered unable to carry out the required study assessments or complete the follow-up visit schedule, in the opinion of the investigating team * Previous stroke (non-recovered) * Recent myocardial infarction (up to 60 days) * Presence of fracture(s) in contralateral leg * Presence of fracture(s) in ipsilateral leg, in addition to the pertrochanteric hip fracture * Known renal or hepatic failure as defined by: * Elevated transaminases ≥ 2.0 x upper limits of normal for: * Serum aspartate aminotransferase (AST) * Serum alanine aminotransferase (ALT) * Significantly impaired renal function as determined by a derived creatinine clearance of ≤ 30 mL/min using the Modification of Diet in Renal Disease equation21

What they're measuring

All patients attending week 4 follow-up visit must be able to perform the TUG test at least once.

Timeframe: 4 weeks

Trial details

NCT IDNCT02788994

SponsorUniversity of Leeds

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-09

Contact for this trial

Peter Giannoudis, MBBS,CCST,MD

01133922750 peter.giannoudis@nhs.net