Actively Recruiting

Phase Not Applicable
Age: 75Years +
All Genders
ID06152198

Internal Fixation Versus Hip Replacement in Older Adults with a Garden I/II Femoral Neck Fracture: Physical Function and Pain in Elderly Patients - a Substudy of the Hipsther Trial

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

340

Participants Needed

1

Research Sites

34 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the impact of two surgical treatments—internal fixation versus hip arthroplasty—on physical function and pain in elderly patients aged 75 and older who have an undisplaced or minimally displaced femoral neck fracture (Garden I or II). This substudy is part of a larger ongoing nationwide randomized controlled trial called HipSTHeR, aiming to recruit 340 patients eligible for either surgical option. The goal is to understand differences in recovery related to these two treatments over time. Participants are randomly assigned to receive either internal fixation, which involves using screws, pins, or similar devices, or hip arthroplasty, which includes cemented total or hemiarthroplasty. The specific type of arthroplasty or osteosynthesis is determined by the surgeon. After surgery, patients included in this substudy are contacted a few weeks later by letter and telephone to provide consent and participate in follow-ups conducted at 4 and 12 months via phone and mail. During follow-ups, participants answer questions about their functional abilities and pain. Researchers evaluate outcomes using the New Mobility Score as the primary measure, assessing indoor and outdoor walking and shopping ability. Additional assessments include the WOMAC scale for hip-specific symptoms, the Katz ADL index for daily living activities, cognitive status using ALFI-MMSE, depression symptoms with the Geriatric Depression Scale (GDS-15), and morale using the Philadelphia Geriatric Center Morale Scale (PGCMS). Data on fracture and treatment are collected from national registries, and the study will continue until 2027, monitoring outcomes at specified intervals.

CONDITIONS

Brief Title

Functional Outcome After ORIF or Arthroplasty for Femoral Neck Fracture

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 unit
  • Provided informed consent
  • Suitable for both internal fixation and hip arthroplasty
  • Included in the Hipsther trial
Not Eligible

You will not qualify if you...

  • No informed consent provided
  • Pathological or stress fracture
  • Peri-implant fracture
  • Previous inclusion of a contralateral Garden I or II femoral neck fracture

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Screening and enrollment visit

Implementation

Duration - Up to 72 hours after fracture

Participants undergo surgery either with internal fixation or hip arthroplasty as determined by their assigned treatment group.

1 surgical visit (in-person)

Follow-up

Duration - 12 months

Participants are contacted by telephone and mail to assess physical function, pain, cognitive status, and well-being at 4 and 12 months after surgery.

2 follow-up contacts (telephone and mail) at 4 and 12 months

Trial Site Locations

Total: 1 location

1

Olof Wolf

Uppsala, Sweden

Actively Recruiting

Loading map...

Research Team

S

Sebastian Mukka, MD, PhD

E

Erika Olofsson, RN

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Similar Trials

A Prospective Multicenter Cohort Study About Internal Fixati...

Femoral Neck Fractures

Actively Recruiting

1 location

Collaboration to Improve Bone Health After Hip Fracture Usin...

Hip Fractures

Actively Recruiting

1 location

Achilles Tendon Homograft for the Treatment of Gluteus Mediu...

Arthroplasty Complications

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

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

A cohort study comparing internal fixation for undisplaced versus hip arthroplasty for displaced femoral neck fracture in the elderly: a pilot study for a clinical trial.

Sebastian Mukka, Pontus Sjöholm, Athir Aziz...

https://pubmed.ncbi.nlm.nih.gov/32670600

Reliability, validity, and responsiveness of the Western Ontario and McMaster Universities Osteoarthritis Index for elderly patients with a femoral neck fracture.

Paul T P W Burgers, Rudolf W Poolman, Theodorus M J Van Bakel...

https://pubmed.ncbi.nlm.nih.gov/25948522

Is arthroplaSty bEtter than interNal fixation for undiSplaced femoral nEck fracture? A national pragmatic RCT: the SENSE trial.

Bjarke Viberg, Søren Kold, Ole Brink...

https://pubmed.ncbi.nlm.nih.gov/33040011