Actively Recruiting

Phase Not Applicable
Age: 75Years +
All Genders
NCT06152198

Functional Outcome After ORIF or Arthroplasty for Femoral Neck Fracture

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

340

Participants Needed

1

Research Sites

323 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Aim To investigate the effect of internal fixation versus hip arthroplasty on physical function and pain in elderly patients. Methods This is a substudy of an on-going nationwide multicenter registry-based RCT named HipSTHeR- (Hip Screws or Total Hip replacement or undisplaced femoral neck fracture in elderly patients) \[21\]. The aim is to recruit 340 patients with undisplaced or minimally displaced femoral neck fracture, Garden 1 or 2, are randomized to surgery either with internal screw fixation or hip arthroplasty. This substudy aims to investigate the potential differences between internal fixation versus hip arthroplasty regarding physical function and pain 4- and 12- months after surgery. Those included in the main study will be contacted by letter a few weeks after the surgery to be invited to participate in a further study. The assessor will then contact the person by telephone to answer further questions and to obtain informed consent. The follow-ups will be conducted over telephone and mail at 4 and 12 months. During the follow-up the participants will answer questions about their functional level. Information on randomisation and fracture data will be acquired from the Swedish Fracture Register and treatment data from the Swedish Hip Arthroplasty Register. Primary outcome The New Mobility Score will be used as the primary outcome with follow-up at 4- and 12 months. Secondary outcome WOMAC will be used as an additional hip specific patient reported outcome. Activities of daily living will be assessed with Katz ADL index to evaluate the patients' performance and the need of assistance in ADL. Patients' cognitive status will be assessed ALFI-MMSE, adapted from Adult Lifestyles and Function Interview (ALFI-MMSE). The Geriatric Depression Scale (GDS-15), which are developed to identify depressive symptoms. The Philadelphia Geriatric Center Morale Scale (PGCMS) and have been used in several studies including frail people living in residential care facilities and can be used among patients with cognitive impairment.

CONDITIONS

Official 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 study center
  • Able to provide informed consent
  • Eligible for both internal fixation and hip arthroplasty treatments
  • Included in the HipSTHeR trial
Not Eligible

You will not qualify if you...

  • Unable to provide informed consent
  • Pathological or stress fractures
  • Peri-implant femoral neck fracture
  • Previously included with 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

Trial Site Locations

Total: 1 location

1

Olof Wolf

Uppsala, Sweden

Actively Recruiting

Loading map...

Research Team

S

Sebastian Mukka, MD, PhD

CONTACT

E

Erika Olofsson, RN

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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