Femoral Neck Fractures, Undisplaced Fracture
Conditions
Keywords
Internal Fixation, Hip Arthroplasty, Reoperation Rate, Mortality, Health Economy, External validity, Adverse events
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.
Interventions
DEVICEArthroplasty
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.
DEVICEInternal Fixation
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.
Sponsors
The Swedish Research Council
Uppsala University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite variable comprising reoperation rate and mortality | 1 to 2-year post-surgery | Both Death and mortality will be accounted for |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Long-term Mortality | 2-year post-surgery | All deaths are recorded |
| Reoperation rate | 2-year post-surgery | Minor and major reoperations will be noted |
| Short-term Mortality | 30 day mortality | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| External validity | 2-year post-surgery | Assessment of eligible patients not included in the study |
| Long-term reoperation rate | 5 and 10 years post-surgery | Minor and major reoperations will be noted |
| Occurrence of adverse events. | 1-year post-surgery | Adverse events, such as pulmonary embolism, infection, dislocation, myocardial infarction and stroke will be noted. |
Countries
Sweden
Contacts
Primary ContactWolf Olof, MD, PhD
Outcome results
None listed