Clinical trial NCT03966716: Hips Screws or (Total) Hip Replacement for Undisplaced Femoral Neck Fractures in Elderly Patients (HipSTHeR)
Official title: HipSTHeR - a Registerbased Randomized Controlled Trial - Hip Screws or (Total) Hip Replacement for Undisplaced Femoral Neck Fractures in Elderly Patients.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Femoral Neck Fractures
Undisplaced Fracture
Keywords: Internal Fixation
Hip Arthroplasty
Reoperation Rate
Mortality
Health Economy
External validity
Adverse events
Lead sponsor: Uppsala University
Sponsor class: OTHER
Collaborators: name: The Swedish Research Council
First posted: 2019-05-29
Enrollment: 1440
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Composite variable comprising reoperation rate and mortality
timeFrame: 1 to 2-year post-surgery
Secondary outcomes:
measure: Reoperation rate
timeFrame: 2-year post-surgery
measure: Long-term Mortality
timeFrame: 2-year post-surgery
measure: Short-term Mortality
timeFrame: 30 day mortality
measure: Patient reported outcome: SMFA
timeFrame: 1-year post surgery
Other outcomes:
measure: Occurrence of adverse events.
timeFrame: 1-year post-surgery
measure: Long-term reoperation rate
timeFrame: 5 and 10 years post-surgery
measure: External validity
timeFrame: 2-year post-surgery
Locations:
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
state: Uppsala Lan
city: Alingsås
country: Sweden
facility: Alingsås Hospital
city: Borås
country: Sweden
facility: Borås Hospital
city: Falun
country: Sweden
facility: Falu Hospital
city: Gothenburg
country: Sweden
facility: Sahlgrenska university Hospital
city: Gävle
country: Sweden
facility: Gävle Hospital
city: Jönköping
country: Sweden
facility: Jönköping Hospital
city: Kalmar
country: Sweden
facility: Kalmar Hospital
city: Karlskrona
country: Sweden
facility: Karlskrona Hospital
city: Kungälv
country: Sweden
facility: Kungälv Hospital
city: Linköping
country: Sweden
facility: Linköping University Hospital
city: Luleå
country: Sweden
facility: Sunderby Hospital
city: Lycksele
country: Sweden
facility: Lycksele Hospital
city: Malmö
country: Sweden
facility: Skåne Universitetssjukhus
city: Mora
country: Sweden
facility: Mora Hospital
city: Norrtälje
country: Sweden
facility: Norrtälje Hospital
city: Nyköping
country: Sweden
facility: Nyköping Hospital
city: Skellefteå
country: Sweden
facility: Skellefteå Hospital
city: Skövde
country: Sweden
facility: Skövde Hospital
city: Stockholm
country: Sweden
facility: Danderyd Hospital
city: Stockholm
country: Sweden
facility: Stockholm South Hospital
city: Trollhättan
country: Sweden
facility: Trollhättan Hospital
city: Umeå
country: Sweden
facility: Umeå University Hospital
city: Västervik
country: Sweden
facility: Västervik Hospital
city: Västerås
country: Sweden
facility: Västerås Hospital
Study officials:
affiliation: Uppsala University Hospital
name: Stergios Lazarinis
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.