NCT06088160

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

October 18, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

December 27, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

July 20, 2025

Status Verified

July 1, 2025

Enrollment Period

1.6 years

First QC Date

September 28, 2023

Last Update Submit

July 16, 2025

Conditions

Keywords

Postural stabilityTotal hip arthroplastyBalance confidenceOsteoarthritisFall

Outcome Measures

Primary Outcomes (2)

  • The Balance Evaluation Systems Test (BESTest)

    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.

    Pre-THA, and at 2, 6, and 12 weeks post-THA

  • The Activities-specific Balance Confidence (ABC) scale

    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.

    Pre-THA, and at 2, 6, and 12 weeks post-THA

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (2)

Direct Anterior

This group will consist of people undergoing elective unilateral THA for OA using the Direct Anterior surgical approach

Procedure: Total Hip Arthroplasty

Direct Lateral

This group will consist of people undergoing elective unilateral THA for OA using the Direct Lateral surgical approach

Procedure: Total Hip Arthroplasty

Interventions

Total hip arthroplasty is a common surgical procedure performed in people with advanced hip osteoarthritis

Also known as: Total hip replacement
Direct AnteriorDirect Lateral

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

People receiving elective unilateral total hip arthroplasty for osteoarthritis

You may qualify if:

  • ≥ 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London Health Sciences Centre- University Hospital

London, Ontario, N6A 5A5, Canada

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, HipOsteoarthritis

Interventions

Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Brent Lanting, MD

    London Health Sciences Centre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tony I Adebero, MSc.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2023

First Posted

October 18, 2023

Study Start

December 27, 2023

Primary Completion

August 1, 2025

Study Completion

November 1, 2025

Last Updated

July 20, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations