Hips Screws or (Total) Hip Replacement for Undisplaced Femoral Neck Fractures in Elderly Patients (HipSTHeR)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Arthroplasty, Internal Fixation.
- Who it may be relevant to
- Registry conditions: Femoral Neck Fractures, Undisplaced Fracture. Basic parameters: from 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
HipSTHeR - a Registerbased Randomized Controlled Trial - Hip Screws or (Total) Hip Replacement for Undisplaced Femoral Neck Fractures in Elderly Patients.
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).
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
- Device Arthroplasty
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. - Device Internal 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.
Primary outcome measures
- Composite variable comprising reoperation rate and mortality [Time frame: 1 to 2-year post-surgery]
Secondary outcome measures (4)
- Reoperation rate [Time frame: 2-year post-surgery]
- Long-term Mortality [Time frame: 2-year post-surgery]
- Short-term Mortality [Time frame: 30 day mortality]
- Patient reported outcome: SMFA [Time frame: 1-year post surgery]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Sweden · 25 centers
- Uppsala University Hospital — Uppsala
- Alingsås Hospital — Alingsås
- Borås Hospital — Borås
- Falu Hospital — Falun
- Gävle Hospital — Gävle
- Sahlgrenska university Hospital — Gothenburg
- Jönköping Hospital — Jönköping
- Kalmar Hospital — Kalmar
- … and 17 more centers
Publications
- Onativia IJ, Slullitel PA, Diaz Dilernia F, Gonzales Viezcas JM, Vietto V, Ramkumar PN, Buttaro MA, Piuzzi NS. Outcomes of nondisplaced intracapsular femoral neck fractures with internal screw fixation in elderly patients: a systematic review. Hip Int. 2018 Jan;28(1):18-28. doi: 10.5301/hipint.5000532. PMID 28665454
- Dolatowski FC, Frihagen F, Bartels S, Opland V, Saltyte Benth J, Talsnes O, Hoelsbrekken SE, Utvag SE. Screw Fixation Versus Hemiarthroplasty for Nondisplaced Femoral Neck Fractures in Elderly Patients: A Multicenter Randomized Controlled Trial. J Bone Joint Surg Am. 2019 Jan 16;101(2):136-144. doi: 10.2106/JBJS.18.00316. PMID 30653043
- Wolf O, Sjoholm P, Hailer NP, Moller M, Mukka S. Study protocol: HipSTHeR - a register-based randomised controlled trial - hip screws or (total) hip replacement for undisplaced femoral neck fractures in older patients. BMC Geriatr. 2020 Jan 21;20(1):19. doi: 10.1186/s12877-020-1418-2. PMID 31964340
Identifiers
NCT: NCT03966716 · 2019-00140