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

Uppsala University

Status: Enrolling

Conditions: Femoral Neck Fractures; Undisplaced Fracture

Treatments: Device: Arthroplasty; Device: Internal Fixation

Study type: Interventional

Funder types: Other

Identifiers

NCT03966716

2019-00140

Details and patient eligibility

About

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).

Full 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.

Enrollment: 1,440 estimated patients

Sex: All

Ages: 75+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,440 participants in 2 patient groups

Arthroplasty

Experimental group

Description:

Arthroplasty, hemi or total depending on patient characteristics and surgeon's choice

Treatment:

Device: Arthroplasty

Internal Fixation

Active Comparator group

Description:

Internal fixation with 2-3 screws or pins, or sliding hip screw device, depending on each hospital's routine

Treatment:

Device: Internal Fixation