Hips Screws or (Total) Hip Replacement for Undisplaced Femoral Neck Fractures in Elderly Patients (HipSTHeR)
NCT03966716 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1440
Last updated 2024-12-03
Summary
A registerbased RCT will investigate whether arthroplasty can decrease the reoperation rate compared to internal fixation for patients with an undisplaced femoral neck fracture (Garden I-II).
Conditions
- Femoral Neck Fractures
- Undisplaced Fracture
Interventions
- DEVICE
-
Arthroplasty
Patients with an undisplaced femoral neck fracture receive a hemi or total hip arthroplasty depending on each hospital's routine for patient age and mobility.
- DEVICE
-
Internal Fixation
Patients with an undisplaced femoral neck fracture undergo a closed reduction and internal fixation with 2-3 screws or pins, or sliding hip screw device. Type of fixation depends on each hospital's routine.
Sponsors & Collaborators
-
The Swedish Research Council
collaborator OTHER_GOV -
Uppsala University
lead OTHER
Principal Investigators
-
Stergios Lazarinis · Uppsala University Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-09-16
- Primary Completion
- 2025-12-31
- Completion
- 2026-09-01
- FDA Device
- Yes
Countries
- Sweden
Study Locations
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