Skip to main content
Clinical Trials/NCT06088160
NCT06088160
Recruiting
Not Applicable

Changes in Postural Stability and Balance Confidence in People After Elective Unilateral Total Hip Arthroplasty for Osteoarthritis: A Prospective Cohort Study

Western University, Canada1 site in 1 country80 target enrollmentDecember 27, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Osteoarthritis, Hip
Sponsor
Western University, Canada
Enrollment
80
Locations
1
Primary Endpoint
The Activities-specific Balance Confidence (ABC) scale
Status
Recruiting
Last Updated
9 months ago

Overview

Brief Summary

Total hip arthroplasty (THA) is a common surgery that eases pain, restores functional movement, and improves the overall quality of life in people with severe hip osteoarthritis (OA). Unfortunately, problems with postural stability, commonly known as balance, are still noticed in people even years after the surgery. These postural stability problems typically result in falls. The aim of the proposed study is to investigate how THA surgery affects a person's overall quality of life, both physically and psychologically, in terms of postural stability and balance confidence (self-efficacy) within the first three months after THA for osteoarthritis. This prospective cohort study will focus on people over 60 years old.

Detailed Description

The purpose of this study is to evaluate the changes in postural stability and balance confidence during the initial three months after elective unilateral total hip arthroplasty for osteoarthritis. Specifically, the investigators aim to: 1. To evaluate change in postural stability between the DA and DL surgical approaches during the first three months after elective unilateral THA for OA, using both a clinical measure and an instrumented measure. 2. To evaluate change in balance confidence between the DA and DL surgical approaches during the first three months after elective unilateral THA for OA. Secondary objective 3. To compare the DA and DL approaches for activity levels, function, quality of life and pain during the first three months after elective unilateral THA for OA.

Registry
clinicaltrials.gov
Start Date
December 27, 2023
End Date
November 1, 2025
Last Updated
9 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Western University, Canada
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • ≥ 60 years of age, scheduled to receive an elective unilateral THA (DA or DL approach) for OA
  • Ambulatory for a minimum of 10 meters with or without a mobility aid but without the assistance of another person
  • Able to read, write and speak English
  • Able to provide consent

Exclusion Criteria

  • Bilateral THA
  • Underwent THA surgery for a diagnosis other than OA
  • Any condition that will prevent participants from completing the study such as having a significant neurological, cardiovascular, musculoskeletal condition as denoted by their physician.

Outcomes

Primary Outcomes

The Activities-specific Balance Confidence (ABC) scale

Time Frame: Pre-THA, and at 2, 6, and 12 weeks post-THA

The 16-item ABC scale assesses the level of confidence a person has in performing a set of daily activities without losing their balance or feeling unsteady. The ABC scale evaluates balance confidence. Each item is rated on scale of 0% (no confidence) to 100% (complete confidence). The final score is the average of all 16-items. ABC scores can be categorized as follows: less than 50 is a low balance confidence, between 50 and 80 is a moderate balance confidence, and over 80 is a high balance confidence.

The Balance Evaluation Systems Test (BESTest)

Time Frame: Pre-THA, and at 2, 6, and 12 weeks post-THA

The BESTest is a comprehensive performance-based postural stability assessment tool. The BESTest consists of 36 items that assess each underlying component of the balance systems framework (i.e., static stability, motor systems, functional stability limits, verticality, reactive postural control, anticipatory postural control, dynamic stability, sensory integration, and cognitive influences). Each item is scored from 0 (severe balance impairment) to 3 (no balance impairment). The maximum total score is 108 points with higher scores representing better postural stability.

Secondary Outcomes

  • Postoperative Fall Assessment: Prospective (daily) number of falls for 12 weeks post-THA, circumstances of falls, and injury (major or minor).(2, 6, and 12 weeks post-THA)
  • The University of California, Los Angeles (UCLA) activity scale(Pre-THA, and at 2, 6, and 12 weeks post-THA)
  • The EuroQol-Five Dimensions-Five Levels (EQ-5D-5L)(Pre-THA, and at 2, 6, and 12 weeks post-THA)
  • The Harris Hip Score(Pre-THA, and at 2, 6, and 12 weeks post-THA)
  • The Western Ontario and McMaster Osteoarthritis Index (WOMAC) questionnaire(Pre-THA, and at 2, 6, and 12 weeks post-THA)
  • Preoperative Fall Assessment: History of falls (previous 12 months), circumstances of falls, and injury (major or minor).(Pre-THA)

Study Sites (1)

Loading locations...

Similar Trials