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

Not Applicable

Recruiting

• Conditions: Femoral Neck Fractures; Undisplaced Fracture
• Interventions: Device: Internal Fixation; Device: Arthroplasty

• Registration Number: NCT03966716
• Lead Sponsor: Uppsala University

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.

Study Timeline

• Study First Submitted: 2019-05-24
• Study First Submitted QC: 2019-05-24
• Study First Posted: 2019-05-29
• Study Start: 2019-09-16
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-28
• Last Update Posted: 2024-12-03
• Primary Completion: 2025-12-31
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1440

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Internal Fixation	Internal Fixation	Internal fixation with 2-3 screws or pins, or sliding hip screw device, depending on each hospital's routine
Arthroplasty	Arthroplasty	Arthroplasty, hemi or total depending on patient characteristics and surgeon's choice

Primary Outcome Measures

Name	Time	Method
Composite variable comprising reoperation rate and mortality	1 to 2-year post-surgery	Both Death and mortality will be accounted for

Secondary Outcome Measures

Name	Time	Method
Reoperation rate	2-year post-surgery	Minor and major reoperations will be noted
Short-term Mortality	30 day mortality	All deaths are recorded
Long-term Mortality	2-year post-surgery	All deaths are recorded
Patient reported outcome: SMFA	1-year post surgery	Short Musculoskeletal Functional Assessment (SMFA) questionnaire, will be routinely collected within the Swedish Fracture Register 1 year after the injury and compared with the results obtained by recall technique at the time of the fracture.

Trial Locations

Locations (25)

Jönköping Hospital; 🇸🇪 Jönköping, Sweden

Kungälv Hospital; 🇸🇪 Kungälv, Sweden

Trollhättan Hospital; 🇸🇪 Trollhättan, Sweden

Västervik Hospital; 🇸🇪 Västervik, Sweden

Uppsala University Hospital; 🇸🇪 Uppsala, Uppsala Lan, Sweden

Alingsås Hospital; 🇸🇪 Alingsås, Sweden

Borås Hospital; 🇸🇪 Borås, Sweden

Falu Hospital; 🇸🇪 Falun, Sweden

Sahlgrenska university Hospital; 🇸🇪 Gothenburg, Sweden

Gävle Hospital; 🇸🇪 Gävle, Sweden

Kalmar Hospital; 🇸🇪 Kalmar, Sweden

Karlskrona Hospital; 🇸🇪 Karlskrona, Sweden

Lycksele Hospital; 🇸🇪 Lycksele, Sweden

Mora Hospital; 🇸🇪 Mora, Sweden

Sunderby Hospital; 🇸🇪 Luleå, Sweden

Linköping University Hospital; 🇸🇪 Linköping, Sweden

Skåne Universitetssjukhus; 🇸🇪 Malmö, Sweden

Skövde Hospital; 🇸🇪 Skövde, Sweden

Norrtälje Hospital; 🇸🇪 Norrtälje, Sweden

Nyköping Hospital; 🇸🇪 Nyköping, Sweden

Skellefteå Hospital; 🇸🇪 Skellefteå, Sweden

Danderyd Hospital; 🇸🇪 Stockholm, Sweden

Stockholm South Hospital; 🇸🇪 Stockholm, Sweden

Umeå University Hospital; 🇸🇪 Umeå, Sweden

Västerås Hospital; 🇸🇪 Västerås, Sweden