RecruitingNot Applicable

Intramedullary Nail Versus Hip Arthroplasty in Unstable Trochanteric Hip Fractures

Norway170 participantsStarted 2021-10-12

Plain-language summary

A hip fracture is a large burden to the patient with increased mortality, pain and increased need for daily assistance. Trochanteric fractures of the femur (FTF) represents about 35% of the hip fractures. Today FTFs are mainly treated with internal fixation using sliding hips screws (SHS) or intramedullary nail (IMN), whilst hip arthroplasty (THA/HA) is rarely used. Despite advances in the design of the internal fixation implants there is a high failure rate, in particular in cases of FTFs classified as unstable fractures. Since the introduction of hip arthroplasty in femoral neck fractures there has been a reduction in complication rates, early mobilization and shorter hospital stays. The primary objective of this project is to investigate if treatment with hip arthroplasty in unstable FTFs will increase the postoperative mobility, give a better general health outcome for the patient, better quality of life and reduce re-operation rate for the patients compared to those operated with the traditional IMN.

Who can participate

Age range

65 Years – 120 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 ≥ 65 years * American Society of Anesthesiology Score (ASA) \< 4 * Ambulant with or without aid (preinjury) * Radiological verified unstable trochanteric hip fracture (AO 31A2.2 - 3.3) * Written consent obtained by patient or his/her next of kin Exclusion Criteria: * Previous hip surgery on ipsilateral or contralateral side * Non-ambulant preinjury * Patient not living in the area of hospital care

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

Patient Reported Outcome Measure (PROM)

Timeframe: Collected at 2, 6 and 12 months from primary surgery

Patient Reported Outcome Measure (PROM)

Timeframe: Collected from 2 to 12 months from primary surgery

Trial details

NCT IDNCT04868305

SponsorHelse Stavanger HF

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2027-03-31

Contact for this trial

Thomas Abel Woldeyesus, MD

+4751513488 thomas.abel.woldeyesus@sus.no

View on ClinicalTrials.gov More Hip Injuries and Disorders trials