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Functional Outcome After ORIF or Arthroplasty for Femoral Neck Fracture

NCT06152198 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 340

Last updated 2024-12-03

No results posted yet for this study

Summary

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

  • Hip Fractures
  • Femoral Neck Fractures
  • Undisplaced Fracture
  • Treatment Complication
  • Internal Fixation; Complications
  • Arthroplasty Complications

Interventions

DEVICE

Treatment

Allocation to hip arthroplasty or internal fixation. The choice between hemi- or total hip arthroplasty in the arthroplasty group and type of osteosynthesis are the surgeon preference.

Sponsors & Collaborators

  • Uppsala University

    lead OTHER

Principal Investigators

  • Olof Wolf, MD, PhD · Uppsala University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-20
Primary Completion
2026-12-31
Completion
2027-09-01

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06152198 on ClinicalTrials.gov