Stabilization of Fresh Unilateral Unstable Pertrochanteric Hip Fracture (NCT02788994) | Clinical Trial Compass
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 range
55 Years – 95 Years
Sex
ALL
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
All patients attending week 4 follow-up visit must be able to perform the TUG test at least once.