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

Uppsala University1,440 enrolled

Overview

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).

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,440

Conditions

Femoral Neck Fractures Undisplaced Fracture

Interventions

ArthroplastyDEVICE

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.

Internal FixationDEVICE

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.

Eligibility

Sex: ALLMin age: 75 Years

Medical Language ↔ Plain English

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

Locations (25)

Uppsala University Hospital

Uppsala, Uppsala County, Sweden

RECRUITING

Outcomes

Primary Outcomes

Composite variable comprising reoperation rate and mortality

Both Death and mortality will be accounted for

Time frame: 1 to 2-year post-surgery

Secondary Outcomes

Reoperation rate

Minor and major reoperations will be noted

Time frame: 2-year post-surgery

Long-term Mortality

All deaths are recorded

Time frame: 2-year post-surgery

Short-term Mortality

All deaths are recorded

Time frame: 30 day mortality

Patient reported outcome: SMFA

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.

Time frame: 1-year post surgery

Central Contacts

Wolf Olof, MD, PhD

CONTACT

+46186111707 olof.wolf@surgsci.uu.se

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.