Comparing hip screws and hip replacement for elderly patients with certain hip fractures
HipSTHeR - a Registerbased Randomized Controlled Trial - Hip Screws or (Total) Hip Replacement for Undisplaced Femoral Neck Fractures in Elderly Patients.
This study tests if hip replacement surgery can help older patients with certain hip fractures avoid needing more surgeries compared to traditional hip screws.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1440 (estimated) |
| Ages | 75 Years and up |
| Sex | All |
| Sponsor | Uppsala University Academic / other |
| Locations | 25 sites (Uppsala, Uppsala County and 24 other locations) |
| Trial ID | NCT03966716 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates whether hip replacement surgery can reduce the need for reoperations compared to traditional internal fixation methods in elderly patients with undisplaced femoral neck fractures. Patients aged 75 and older will be randomly assigned to receive either internal fixation or arthroplasty, with the choice of hemi or total hip replacement left to the surgeon's discretion. The study will utilize data from the Swedish Fracture Register to assess outcomes, focusing on reoperation rates and mortality as primary endpoints.
Who should consider this trial
Good fit: Ideal candidates for this study are elderly patients aged 75 years and older with an undisplaced femoral neck fracture.
Not a fit: Patients with pathological or stress fractures, or those unable to provide informed consent, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for elderly patients with hip fractures, potentially reducing the need for additional surgeries.
How similar studies have performed: Previous studies have explored similar surgical approaches, but this specific comparison of hip replacement versus internal fixation in this patient population is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Undisplaced (Garden I-II) femoral neck fracture (within 72h) * treated at participating unit * informed consent * amenable for both treatment options Exclusion Criteria: * no informed consent * pathological or stress fracture * peri-implant fracture
Where this trial is running
Uppsala, Uppsala County and 24 other locations
- Uppsala University Hospital — Uppsala, Uppsala County, Sweden (Recruiting)
- Alingsås Hospital — Alingsås, Sweden (Recruiting)
- Borås Hospital — Borås, Sweden (Recruiting)
- Falu Hospital — Falun, Sweden (Recruiting)
- Gävle Hospital — Gävle, Sweden (Recruiting)
- Sahlgrenska university Hospital — Gothenburg, Sweden (Recruiting)
- Jönköping Hospital — Jönköping, Sweden (Recruiting)
- Kalmar Hospital — Kalmar, Sweden (Recruiting)
- Karlskrona Hospital — Karlskrona, Sweden (Recruiting)
- Kungälv Hospital — Kungälv, Sweden (Recruiting)
- Linköping University Hospital — Linköping, Sweden (Recruiting)
- Sunderby Hospital — Luleå, Sweden (Recruiting)
- Lycksele Hospital — Lycksele, Sweden (Recruiting)
- Skåne Universitetssjukhus — Malmö, Sweden (Recruiting)
- Mora Hospital — Mora, Sweden (Recruiting)
- Norrtälje Hospital — Norrtälje, Sweden (Not_yet_recruiting)
- Nyköping Hospital — Nyköping, Sweden (Recruiting)
- Skellefteå Hospital — Skellefteå, Sweden (Recruiting)
- Skövde Hospital — Skövde, Sweden (Recruiting)
- Danderyd Hospital — Stockholm, Sweden (Recruiting)
- Stockholm South Hospital — Stockholm, Sweden (Not_yet_recruiting)
- Trollhättan Hospital — Trollhättan, Sweden (Recruiting)
- Umeå University Hospital — Umeå, Sweden (Recruiting)
- Västerås Hospital — Västerås, Sweden (Recruiting)
- Västervik Hospital — Västervik, Sweden (Recruiting)
Study contacts
- Study coordinator: Wolf Olof, MD, PhD
- Email: olof.wolf@surgsci.uu.se
- Phone: +46186111707
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.