Comparing hip arthroplasty and intramedullary nail for unstable hip fractures
Randomized Clinical Trial: Treatment of Unstable Trochanteric Hip Fractures With Intramedullary Nail Versus Hip Arthroplasty: Survival, Complications and Postoperative Patient Reported Outcomes
This study is testing whether hip replacement surgery works better than a special nail for helping older adults with unstable hip fractures recover and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 170 (estimated) |
| Ages | 65 Years to 120 Years |
| Sex | All |
| Sponsor | Helse Stavanger HF Government |
| Locations | 1 site (Stavanger) |
| Trial ID | NCT04868305 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of hip arthroplasty compared to intramedullary nail fixation in treating unstable trochanteric hip fractures. The study aims to determine if hip arthroplasty can improve postoperative mobility, overall health outcomes, and quality of life while reducing the need for reoperations. Patients aged 65 and older with specific types of unstable fractures will be enrolled, and their recovery will be monitored to assess the benefits of each treatment method. The trial is conducted at Stavanger University Hospital in Norway.
Who should consider this trial
Good fit: Ideal candidates are patients aged 65 and older with unstable trochanteric hip fractures who were ambulant prior to injury.
Not a fit: Patients who are non-ambulant before the injury or have had previous hip surgery on the affected side may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved recovery and quality of life for patients with unstable trochanteric hip fractures.
How similar studies have performed: While there is substantial research on femoral neck fractures, this specific comparison of treatment methods for unstable trochanteric fractures is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Stavanger
- Stavanger University Hospital — Stavanger, Norway (Recruiting)
Study contacts
- Principal investigator: Ane Djuv, MD., PhD — Helse Stavanger HF
- Study coordinator: Thomas Abel Woldeyesus, MD
- Email: thomas.abel.woldeyesus@sus.no
- Phone: +4751513488
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.