Hips Screws or (Total) Hip Replacement for Undisplaced Femoral Neck Fractures in Elderly Patients (HipSTHeR)

Femoral Neck Fractures Clinical Trial

— HipSTHeR  

Official title:

HipSTHeR - a Registerbased Randomized Controlled Trial - Hip Screws or (Total) Hip Replacement for Undisplaced Femoral Neck Fractures in Elderly Patients.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03966716
• Other study ID #: 2019-00140
• Status: Recruiting
• Phase: N/A
• Start date: September 16, 2019
• Est. completion date: September 1, 2026

Study information

• Verified date: June 2023
• Source: Uppsala University
• Contact: Wolf Olof, MD, PhD
• Phone: +46186111707
• Email: olof.wolf[@]surgsci.uu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1440
• Est. completion date: September 1, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Femoral Neck Fractures
• Fractures, Bone
• Undisplaced Fracture

Intervention

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.
• 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.

Locations

Country	Name	City	State
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	Malmö
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	Uppsala University Hospital	Uppsala	Uppsala Lan
Sweden	Västerås Hospital	Västerås
Sweden	Västervik Hospital	Västervik

Sponsors (2)

Lead Sponsor	Collaborator
Uppsala University	The Swedish Research Council

Country where clinical trial is conducted

Sweden, 

References & Publications (2)

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. — View 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. Erratum In: Hip Int. 2020 Mar;30(2):NP1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Occurrence of adverse events.	Adverse events, such as pulmonary embolism, infection, dislocation, myocardial infarction and stroke will be noted.	1-year post-surgery
Other	Long-term reoperation rate	Minor and major reoperations will be noted	5 and 10 years post-surgery
Other	External validity	Assessment of eligible patients not included in the study	2-year post-surgery
Primary	Composite variable comprising reoperation rate and mortality	Both Death and mortality will be accounted for	1 to 2-year post-surgery
Secondary	Reoperation rate	Minor and major reoperations will be noted	2-year post-surgery
Secondary	Long-term Mortality	All deaths are recorded	2-year post-surgery
Secondary	Short-term Mortality	All deaths are recorded	30 day mortality
Secondary	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.	1-year post surgery