Actively Recruiting

Phase Not Applicable
Age: 75Years +
All Genders
ID03966716

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

Led by Uppsala University · Updated on 2024-12-03

1440

Participants Needed

25

Research Sites

34 weeks

Total Duration

On this page

Sponsors

U

Uppsala University

Lead Sponsor

T

The Swedish Research Council

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to determine if hip replacement surgery (arthroplasty) can reduce the need for additional operations compared to internal fixation in elderly patients with an undisplaced femoral neck fracture. Patients aged 75 years and older with this type of fracture will be included and randomly assigned to one of two treatments through the Swedish Fracture Register platform. The study focuses on combining reoperation rates and mortality into a single main outcome measure to evaluate which treatment offers better results. Participants will receive either arthroplasty, which may be hemi or total hip replacement depending on the patient's condition and surgeon's decision, or internal fixation using screws, pins, or a sliding hip screw device based on hospital routine. The study is a randomized controlled trial without blinding, comparing these two device-based treatments for hip fractures in elderly patients. During the study, researchers will monitor the combined rate of reoperations and mortality for 1 to 2 years after surgery. Additional outcomes include reoperation rates, short- and long-term mortality, and patient-reported physical function one year after surgery. Participants will be followed up to assess these outcomes, with care taken to track their progress and safety over the study period.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 75Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Undisplaced (Garden I-II) femoral neck fracture within 72 hours
  • Treated at a participating hospital
  • Able to provide informed consent
  • Suitable for both hip replacement and internal fixation treatments
Not Eligible

You will not qualify if you...

  • No informed consent provided
  • Pathological or stress fracture
  • Peri-implant fracture

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Surgery and immediate post-operative period

Participants undergo surgery with either hip arthroplasty (hemi or total) or internal fixation using screws or a sliding hip screw device, according to hospital routine and surgeon’s choice.

1 surgical procedure and hospital stay

Post-operative Follow-up

Duration - Up to 2 years post-surgery

Participants are followed to monitor recovery, reoperation rates, and mortality outcomes after surgery.

Regular follow-up visits as per hospital routine during 2 years

Trial Site Locations

Total: 25 locations

1

Uppsala University Hospital

Uppsala, Uppsala County, Sweden, 75185

Actively Recruiting

2

Alingsås Hospital

Alingsås, Sweden

Actively Recruiting

3

Borås Hospital

Borås, Sweden

Actively Recruiting

4

Falu Hospital

Falun, Sweden

Actively Recruiting

5

Gävle Hospital

Gävle, Sweden

Actively Recruiting

6

Sahlgrenska university Hospital

Gothenburg, Sweden

Actively Recruiting

7

Jönköping Hospital

Jönköping, Sweden

Actively Recruiting

8

Kalmar Hospital

Kalmar, Sweden

Actively Recruiting

9

Karlskrona Hospital

Karlskrona, Sweden

Actively Recruiting

10

Kungälv Hospital

Kungälv, Sweden

Actively Recruiting

11

Linköping University Hospital

Linköping, Sweden

Actively Recruiting

12

Sunderby Hospital

Luleå, Sweden

Actively Recruiting

13

Lycksele Hospital

Lycksele, Sweden

Actively Recruiting

14

Skåne Universitetssjukhus

Malmö, Sweden

Actively Recruiting

15

Mora Hospital

Mora, Sweden

Actively Recruiting

16

Norrtälje Hospital

Norrtälje, Sweden

Not Yet Recruiting

17

Nyköping Hospital

Nyköping, Sweden

Actively Recruiting

18

Skellefteå Hospital

Skellefteå, Sweden

Actively Recruiting

19

Skövde Hospital

Skövde, Sweden

Actively Recruiting

20

Danderyd Hospital

Stockholm, Sweden

Actively Recruiting

21

Stockholm South Hospital

Stockholm, Sweden

Not Yet Recruiting

22

Trollhättan Hospital

Trollhättan, Sweden

Actively Recruiting

23

Umeå University Hospital

Umeå, Sweden

Actively Recruiting

24

Västerås Hospital

Västerås, Sweden

Actively Recruiting

25

Västervik Hospital

Västervik, Sweden

Actively Recruiting

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Research Team

W

Wolf Olof, MD, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Outcomes of nondisplaced intracapsular femoral neck fractures with internal screw fixation in elderly patients: a systematic review.

Ignacio J Oñativia, Pablo A.I. Slullitel, Fernando Diaz Dilernia...

https://pubmed.ncbi.nlm.nih.gov/28665454

Screw Fixation Versus Hemiarthroplasty for Nondisplaced Femoral Neck Fractures in Elderly Patients: A Multicenter Randomized Controlled Trial.

Filip C Dolatowski, Frede Frihagen, Stefan Bartels...

https://pubmed.ncbi.nlm.nih.gov/30653043

Study protocol: HipSTHeR - a register-based randomised controlled trial - hip screws or (total) hip replacement for undisplaced femoral neck fractures in older patients.

Olof Wolf, Pontus Sjöholm, Nils P Hailer...

https://pubmed.ncbi.nlm.nih.gov/31964340