Clinical trial NCT06088160: Changes in Postural Stability Following THA for OA
Official title: Changes in Postural Stability and Balance Confidence in People After Elective Unilateral Total Hip Arthroplasty for Osteoarthritis: A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Osteoarthritis, Hip
Keywords: Postural stability
Total hip arthroplasty
Balance confidence
Osteoarthritis
Fall
Lead sponsor: Western University, Canada
Sponsor class: OTHER
First posted: 2023-10-18
Enrollment: 80
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People receiving elective unilateral total hip arthroplasty for osteoarthritis

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.

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.

Primary outcomes:
measure: The Balance Evaluation Systems Test (BESTest)
timeFrame: Pre-THA, and at 2, 6, and 12 weeks post-THA
measure: The Activities-specific Balance Confidence (ABC) scale
timeFrame: Pre-THA, and at 2, 6, and 12 weeks post-THA
Secondary outcomes:
measure: The University of California, Los Angeles (UCLA) activity scale
timeFrame: Pre-THA, and at 2, 6, and 12 weeks post-THA
measure: The EuroQol-Five Dimensions-Five Levels (EQ-5D-5L)
timeFrame: Pre-THA, and at 2, 6, and 12 weeks post-THA
measure: The Harris Hip Score
timeFrame: Pre-THA, and at 2, 6, and 12 weeks post-THA
measure: The Western Ontario and McMaster Osteoarthritis Index (WOMAC) questionnaire
timeFrame: Pre-THA, and at 2, 6, and 12 weeks post-THA
measure: Preoperative Fall Assessment: History of falls (previous 12 months), circumstances of falls, and injury (major or minor).
timeFrame: Pre-THA
measure: Postoperative Fall Assessment: Prospective (daily) number of falls for 12 weeks post-THA, circumstances of falls, and injury (major or minor).
timeFrame: 2, 6, and 12 weeks post-THA
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre- University Hospital
state: Ontario
Study officials:
affiliation: London Health Sciences Centre
name: Brent Lanting, MD
role: PRINCIPAL_INVESTIGATOR
References: