MedDataX Logo

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

NCT ID: NCT03966716

Last Updated: 2024-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1440 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-16

Study Completion Date

2026-09-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Femoral Neck Fractures Undisplaced Fracture

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arthroplasty

Arthroplasty, hemi or total depending on patient characteristics and surgeon's choice

Group Type EXPERIMENTAL

Arthroplasty

Intervention Type DEVICE

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

Internal fixation with 2-3 screws or pins, or sliding hip screw device, depending on each hospital's routine

Group Type ACTIVE_COMPARATOR

Internal Fixation

Intervention Type DEVICE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The Swedish Research Council

OTHER_GOV

Sponsor Role collaborator

Uppsala University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Stergios Lazarinis

Role: STUDY_CHAIR

Uppsala University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Uppsala University Hospital

Uppsala, Uppsala County, Sweden

Site Status RECRUITING

Alingsås Hospital

Alingsås, , Sweden

Site Status RECRUITING

Borås Hospital

Borås, , Sweden

Site Status RECRUITING

Falu Hospital

Falun, , Sweden

Site Status RECRUITING

Gävle Hospital

Gävle, , Sweden

Site Status RECRUITING

Sahlgrenska university Hospital

Gothenburg, , Sweden

Site Status RECRUITING

Jönköping Hospital

Jönköping, , Sweden

Site Status RECRUITING

Kalmar Hospital

Kalmar, , Sweden

Site Status RECRUITING

Karlskrona Hospital

Karlskrona, , Sweden

Site Status RECRUITING

Kungälv Hospital

Kungälv, , Sweden

Site Status RECRUITING

Linköping University Hospital

Linköping, , Sweden

Site Status RECRUITING

Sunderby Hospital

Luleå, , Sweden

Site Status RECRUITING

Lycksele Hospital

Lycksele, , Sweden

Site Status RECRUITING

Skåne Universitetssjukhus

Malmo, , Sweden

Site Status RECRUITING

Mora Hospital

Mora, , Sweden

Site Status RECRUITING

Norrtälje Hospital

Norrtälje, , Sweden

Site Status NOT_YET_RECRUITING

Nyköping Hospital

Nyköping, , Sweden

Site Status RECRUITING

Skellefteå Hospital

Skellefteå, , Sweden

Site Status RECRUITING

Skövde Hospital

Skövde, , Sweden

Site Status RECRUITING

Danderyd Hospital

Stockholm, , Sweden

Site Status RECRUITING

Stockholm South Hospital

Stockholm, , Sweden

Site Status NOT_YET_RECRUITING

Trollhättan Hospital

Trollhättan, , Sweden

Site Status RECRUITING

Umeå University Hospital

Umeå, , Sweden

Site Status RECRUITING

Västerås Hospital

Västerås, , Sweden

Site Status RECRUITING

Västervik Hospital

Västervik, , Sweden

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Sweden

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Wolf Olof, MD, PhD

Role: CONTACT

[email protected]
+46186111707

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Olof Wolf, MD PhD

Role: primary

[email protected]
+46709728284

Nils Hailer, MD Prof

Role: backup

[email protected]
+46186119038

Mia Jodal

Role: primary

Per-Erik Johansson

Role: primary

Daniel Fröjd

Role: primary

Hans-Peter Bögl

Role: primary

Michael Möller

Role: primary

David Hengst

Role: backup

Robert Gustafsson

Role: primary

Emil Ohlsén

Role: primary

Olof Leonardsson

Role: primary

Ivan Cvetanovic

Role: primary

Jörg Schilcher

Role: primary

Nicole Jessen

Role: primary

Algirdas Petrauskas

Role: primary

Cecilia Rogmark

Role: primary

Christoffer Thorsell

Role: primary

Sarwar Mahmood

Role: primary

Magdalena Wellhagen

Role: primary

Constantinos Papadopoulus

Role: primary

Henrik Ståhl

Role: primary

Olof Sköldenberg

Role: primary

Piotr Kasina

Role: primary

Andreas Sylvan

Role: primary

Sebastian Mukka, Ass Prof

Role: primary

[email protected]

Gunnar Victorin

Role: primary

Johan Liliequist

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 28665454 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30653043 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31964340 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2019-00140

Identifier Type: -

Identifier Source: org_study_id