Undisplaced Femoral Neck Fractures in the Elderly: A Trial Comparing Internal Fixation to Hemiart… (NCT01770769) | Clinical Trial Compass
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Undisplaced Femoral Neck Fractures in the Elderly: A Trial Comparing Internal Fixation to Hemiarthroplasty
Norway220 participantsStarted 2012-02-06
Plain-language summary
Clinical research during the last ten years has revealed that elderly patients with a displaced femoral neck fracture should be treated with arthroplasty instead of closed reduction of the fracture followed by internal fixation with pins or screws. Few clinical trials have addressed undisplaced or minimally displaced fractures of the femoral neck. These fractures have been associated with a good prognosis and likewise a good functional outcome. However, recent articles present far less favorable results, with high re-operation rates (10-15%), reduced function, and pain on walking after internal fixation. Indirect comparing studies, suggest that hemiarthroplasty may yield better functional outcomes and lower re-operation rates. Approximately 20% of all femoral neck fractures in patients aged 70 years or older are minimally displaced or undisplaced. Hence the investigators call for a randomised controlled trial comparing pain, function, walking ability, quality of life, re-operation rates and complications after internal fixation versus hemiarthroplasty in patients aged 70 years and older.
Who can participate
Age range
70 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 70 years or older
* Undisplaced or minimally displaced intracapsular femoral neck fracture (Garden I/II)
* Patient able to walk before injury (all aids allowed)
* Patient lives within the catchment area of the three involved centres
Exclusion Criteria:
* Displaced fractures (Garden III/IV) and impacted fractures with minimal varus
* Pathologic fracture
* Current soft tissue or deep infection in the hip or pelvis area
* ASA IV patients as classified by the anesthesiologist on call
* Other contraindications to either of the two methods compared
* Temporarily impaired cognitive function:
(That is when the patient is judged as unable to provide an informed consent by the surgeon on call and there is no previous history of impaired cognitive function as documented by previous hospital record or a family member / proxy)
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
Change in Harris Hip Score of 10 points or more.
Timeframe: Baseline prior to fracture, 3 months, 1 year and 2 years