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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Femoral Neck Fractures, Undisplaced Fracture

Intervention / Treatment
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* Device: Arthroplasty
* Device: Internal Fixation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arthroplasty<br>Arthroplasty, hemi or total depending on patient characteristics and surgeon's choice | Device: Arthroplasty<br>* 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.<br>|
| Active Comparator: Internal Fixation<br>Internal fixation with 2-3 screws or pins, or sliding hip screw device, depending on each hospital's routine | Device: Internal Fixation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite variable comprising reoperation rate and mortality | Both Death and mortality will be accounted for | 1 to 2-year post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reoperation rate | Minor and major reoperations will be noted | 2-year post-surgery | 
| Long-term Mortality | All deaths are recorded | 2-year post-surgery | 
| Short-term Mortality | All deaths are recorded | 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. | 1-year post surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adverse events, Internal Fixation, Hip Arthroplasty, Reoperation Rate, Mortality, Health Economy, External validity