Hips Screws or (Total) Hip Replacement for Undisplaced Femoral Neck Fractures in Elderly Patients (HipSTHeR)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age75+
SponsorUppsala University
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Undisplaced (Garden I-II) femoral neck fracture (within 72h)
treated at participating unit
informed consent
amenable for both treatment options
Disqualifiers
no informed consent
pathological or stress fracture
peri-implant fracture
Trial design
Design model
Parallel
Treatments tested in this trial
Arthroplasty
DevicePatients 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 Fixation
DevicePatients 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.
Treatment groups
1,440 Participants
are divided into 2 treatment groupsGroup A: ArthroplastyExperimental treatment 1 intervention
Group B: Internal FixationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Composite variable comprising reoperation rate and mortality
Both Death and mortality will be accounted for
Time frame
1 to 2-year post-surgerySecondary outcomes
1
Reoperation rate
Minor and major reoperations will be noted
Time frame
2-year post-surgery2
Long-term Mortality
All deaths are recorded
Time frame
2-year post-surgery3
Short-term Mortality
All deaths are recorded
Time frame
30 day mortality4
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 surgeryOther outcomes
1
Occurrence of adverse events.
Adverse events, such as pulmonary embolism, infection, dislocation, myocardial infarction and stroke will be noted.
Time frame
1-year post-surgery2
Long-term reoperation rate
Minor and major reoperations will be noted
Time frame
5 and 10 years post-surgery3
External validity
Assessment of eligible patients not included in the study
Time frame
2-year post-surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Uppsala University
Lead sponsor
The Swedish Research Council
Collaborator
Source ClinicalTrials.gov