NCT03966716

Hips Screws or (Total) Hip Replacement for Undisplaced Femoral Neck Fractures in Elderly Patients (HipSTHeR)

HipSTHeR - a Registerbased Randomized Controlled Trial - Hip Screws or (Total) Hip Replacement for Undisplaced Femoral Neck Fractures in Elderly Patients.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,440 (estimated)
• Sponsor: Uppsala University · Academic / Other
• Sex: All
• Age: 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Femoral Neck Fractures
• Undisplaced Fracture

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-09-16
• Primary completion: 2025-12-31
• Completion: 2026-09-01
• First posted: 2019-05-29
• Last updated: 2024-12-03

Locations

25 sites across 1 country: Sweden

Regulatory

• FDA-regulated device study