Hips Screws or (Total) Hip Replacement for Undisplaced Femoral Neck Fractures in Elderly Patients (HipSTHeR)
HipSTHeR
HipSTHeR - a Registerbased Randomized Controlled Trial - Hip Screws or (Total) Hip Replacement for Undisplaced Femoral Neck Fractures in Elderly Patients.
1 other identifier
interventional
1,440
1 country
25
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2019
Longer than P75 for not_applicable
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 24, 2019
CompletedFirst Posted
Study publicly available on registry
May 29, 2019
CompletedStudy Start
First participant enrolled
September 16, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
ExpectedDecember 3, 2024
November 1, 2024
6.3 years
May 24, 2019
November 28, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Composite variable comprising reoperation rate and mortality
Both Death and mortality will be accounted for
1 to 2-year post-surgery
Secondary Outcomes (4)
Reoperation rate
2-year post-surgery
Long-term Mortality
2-year post-surgery
Short-term Mortality
30 day mortality
Patient reported outcome: SMFA
1-year post surgery
Other Outcomes (3)
Occurrence of adverse events.
1-year post-surgery
Long-term reoperation rate
5 and 10 years post-surgery
External validity
2-year post-surgery
Study Arms (2)
Arthroplasty
EXPERIMENTALArthroplasty, hemi or total depending on patient characteristics and surgeon's choice
Internal Fixation
ACTIVE COMPARATORInternal fixation with 2-3 screws or pins, or sliding hip screw device, depending on each hospital's routine
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Undisplaced (Garden I-II) femoral neck fracture (within 72h)
- treated at participating unit
- informed consent
- amenable for both treatment options
You may not qualify if:
- no informed consent
- pathological or stress fracture
- peri-implant fracture
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Uppsala Universitylead
- The Swedish Research Councilcollaborator
Study Sites (25)
Uppsala University Hospital
Uppsala, Uppsala County, 75185, Sweden
Alingsås Hospital
Alingsås, Sweden
Borås Hospital
Borås, Sweden
Falu Hospital
Falun, Sweden
Gävle Hospital
Gävle, Sweden
Sahlgrenska university Hospital
Gothenburg, Sweden
Jönköping Hospital
Jönköping, Sweden
Kalmar Hospital
Kalmar, Sweden
Karlskrona Hospital
Karlskrona, Sweden
Kungälv Hospital
Kungälv, Sweden
Linköping University Hospital
Linköping, Sweden
Sunderby Hospital
Luleå, Sweden
Lycksele Hospital
Lycksele, Sweden
Skåne Universitetssjukhus
Malmo, Sweden
Mora Hospital
Mora, Sweden
Norrtälje Hospital
Norrtälje, Sweden
Nyköping Hospital
Nyköping, Sweden
Skellefteå Hospital
Skellefteå, Sweden
Skövde Hospital
Skövde, Sweden
Danderyd Hospital
Stockholm, Sweden
Stockholm South Hospital
Stockholm, Sweden
Trollhättan Hospital
Trollhättan, Sweden
Umeå University Hospital
Umeå, Sweden
Västerås Hospital
Västerås, Sweden
Västervik Hospital
Västervik, Sweden
Related Publications (3)
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: 28665454BACKGROUNDDolatowski 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: 30653043BACKGROUNDWolf 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: 31964340DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Stergios Lazarinis
Uppsala University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 24, 2019
First Posted
May 29, 2019
Study Start
September 16, 2019
Primary Completion
December 31, 2025
Study Completion (Estimated)
September 1, 2026
Last Updated
December 3, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share