HipSTHeR - a Registerbased Randomized Controlled Trial - Hip Screws or (Total) Hip Replacement for Undisplaced Femoral Neck Fractures in Elderly Patients.
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Femoral Neck Fractures
- Sponsor
- Uppsala University
- Enrollment
- 1440
- Locations
- 25
- Primary Endpoint
- Composite variable comprising reoperation rate and mortality
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief 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).
Detailed Description
The aim of this study is to determine whether the treatment of elderly patients with an undisplaced femoral neck fracture (uFNF) can be improved by decreasing reoperation rates through replacing the hip instead of trying to preserve it. Patients ≥75 years with an uFNF will be included and randomized within the Swedish Fracture Register (SFR) platform to internal fixation (screws/pins) or arthroplasty (choice of hemi or total is at the surgeon's discretion). The primary outcome will be a composite variable that combines two variables (reoperations and mortality) into a single variable.
Investigators
Eligibility 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
Outcomes
Primary Outcomes
Composite variable comprising reoperation rate and mortality
Time Frame: 1 to 2-year post-surgery
Both Death and mortality will be accounted for
Secondary Outcomes
- Reoperation rate(2-year post-surgery)
- Short-term Mortality(30 day mortality)
- Long-term Mortality(2-year post-surgery)
- Patient reported outcome: SMFA(1-year post surgery)