Osteoarthritis, HipCPSNCT06088160
Changes in Postural Stability Following THA for OA
An observational study of Osteoarthritis, Hip, run by Western University, Canada at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Osteoarthritis, Hip
- What is being tested?
- Total Hip Arthroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 90 participants
- Where
- 1 siteCanada
- Study dates
- 27 Dec 2023to 21 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People receiving elective unilateral total hip arthroplasty for osteoarthritis
Who may be able to join
- ≥ 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
London Health Sciences Centre- University Hospital
London, Ontario, N6A 5A5
About this study
Official title: Changes in Postural Stability and Balance Confidence in People After Elective Unilateral Total Hip Arthroplasty for Osteoarthritis: A Prospective Cohort Study
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.
Read the 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:
- 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.
- 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
- 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.
- Conditions
- Osteoarthritis, Hip
- Being tested
- Total Hip Arthroplasty
- Keywords
- Postural stability, Total hip arthroplasty, Balance confidence, Osteoarthritis, Fall
- Medical subject headings
- Osteoarthritis, Hip, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Hip ArthroplastyProcedure or surgery
Also called Total hip replacement
Total hip arthroplasty is a common surgical procedure performed in people with advanced hip osteoarthritis
| Study group | Role | What they receive |
|---|---|---|
| Direct Anterior | This group will consist of people undergoing elective unilateral THA for OA using the Direct Anterior surgical approach Receives: Procedure: Total Hip Arthroplasty | |
| Direct Lateral | This group will consist of people undergoing elective unilateral THA for OA using the Direct Lateral surgical approach Receives: Procedure: Total Hip Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Pre-THA, and at 2, 6, and 12 weeks post-THA
Secondary outcomes (6)
The University of California, Los Angeles (UCLA) activity scale
The UCLA activity scale measures physical activity on a scale from 1 ("no physical activity, dependent on others") to 10 ("regular participation in impact sports"). It has been identified as the most suitable scale for assessing physical activity levels in people undergoing total joint arthroplasty.
Measured: Pre-THA, and at 2, 6, and 12 weeks post-THA
The EuroQol-Five Dimensions-Five Levels (EQ-5D-5L)
The EQ-5D-5L is a generic preference-based measure that evaluates five dimensions of health-related quality of life: mobility, self-care, usual activities, pain/discomfort (PD), and anxiety/depression (AD). Each dimension has five response levels representing no, slight, moderate, severe, and extreme problems. In addition to the five dimensions, the EQ-5D-5L includes the EuroQol-visual analogue scales (EQ VAS), which allow individuals to rate their health status on a scale ranging from 0 (worst imaginable health) to 100 (best imaginable health). By using the Canadian EQ-5D-5L value set, health state utility values can be assigned to an EQ-described health state, ranging from -0.148 (representing 55,555) to 0.949 (representing 11,111). This is referred to as EQ-5D-5L utility.
Measured: Pre-THA, and at 2, 6, and 12 weeks post-THA
The Harris Hip Score
The Harris Hip Score is an outcome measure completed by the surgeon and evaluates four domains related to the operated limb: pain, function, range of motion and absence of deformity. The score ranges from 0 (lowest outcome) to 100 (best outcome). Scoring can be interpreted as poor (<70), fair (70-79), good (80-89) or excellent (90-100).
Measured: Pre-THA, and at 2, 6, and 12 weeks post-THA
The Western Ontario and McMaster Osteoarthritis Index (WOMAC) questionnaire
The WOMAC is a patient self-administered 24-item questionnaire divided into 3 subscales that assess pain, stiffness and joint function. For this study, a weighted and inverted conversion will be used for each domain with a maximum score of 100, where a higher score will indicate better overall health status.
Measured: 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).
A history of fall questionnaire will be provided to participants to ascertain any falls that occurred in the previous 12 months before the THA surgery, circumstances of falls, and if any injuries occurred.
A fall will be defined as an "unintentional coming to rest on the ground, floor or other lower level". Injuries will be categorized as major or minor. A major injury is defined as any fall that necessitates medical attention for the treatment of a fracture, while a minor injury is a bruise or laceration, where medical attention may or may not have been necessary.
Measured: Pre-THA
Postoperative Fall Assessment: Prospective (daily) number of falls for 12 weeks post-THA, circumstances of falls, and injury (major or minor).
Participants will be provided with a journal to record any falls (daily), circumstances of falls and information on any injuries. A face-to-face meeting will be conducted during their postoperative appointments to rectify any missing information. A fall will be defined as an "unintentional coming to rest on the ground, floor or other lower level". Injuries will be categorized as major or minor. A major injury is defined as any fall that necessitates medical attention for the treatment of a fracture, while a minor injury is a bruise or laceration, where medical attention may or may not have been necessary.
Measured: 2, 6, and 12 weeks post-THA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start27 Dec 2023
- Primary completion21 Oct 2025
- Study completion21 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, HipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brent Lanting, MD, Principal investigator, London Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06088160
- Sponsor's protocol ID
- 123634
- Acronym
- CPS
- Status last verified
- Jul 2025
- First submitted
- 28 Sep 2023
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Postural Stability and Balance Confidence in People After Elective Unilateral Total Hip Arthroplasty for Osteoarthritis: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06088160
- Acronym / sponsor ID
- CPS / 123634
- Conditions
- Osteoarthritis, Hip
- Keywords
- Postural stability, Total hip arthroplasty, Balance confidence, Osteoarthritis, Fall
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Study start
- 27 Dec 2023 (actual)
- Primary completion
- 21 Oct 2025 (actual)
- Study completion
- 21 Nov 2025 (actual)
- First posted
- 18 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Direct Anterior | – | Procedure: Total Hip ArthroplastyThis group will consist of people undergoing elective unilateral THA for OA using the Direct Anterior surgical approach |
| Direct Lateral | – | Procedure: Total Hip ArthroplastyThis group will consist of people undergoing elective unilateral THA for OA using the Direct Lateral surgical approach |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People receiving elective unilateral total hip arthroplasty for osteoarthritis
Key inclusion criteria (4 listed)
- ≥ 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total Hip ArthroplastyAlso: Total hip replacementTotal hip arthroplasty is a common surgical procedure performed in people with advanced hip osteoarthritis | Procedure or surgery | Direct Anterior, Direct Lateral |
Primary outcome
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.
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.
6 secondary outcomes
The University of California, Los Angeles (UCLA) activity scale
Time frame: Pre-THA, and at 2, 6, and 12 weeks post-THA
The EuroQol-Five Dimensions-Five Levels (EQ-5D-5L)
Time frame: Pre-THA, and at 2, 6, and 12 weeks post-THA
The Harris Hip Score
Time frame: Pre-THA, and at 2, 6, and 12 weeks post-THA
The Western Ontario and McMaster Osteoarthritis Index (WOMAC) questionnaire
Time frame: 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).
Time frame: Pre-THA
Postoperative Fall Assessment: Prospective (daily) number of falls for 12 weeks post-THA, circumstances of falls, and injury (major or minor).
Time frame: 2, 6, and 12 weeks post-THA
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brent Lanting, MD principal investigator
London Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Hip, run by Western University, Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Balance Evaluation Systems Test (BESTest) (time frame: Pre-THA, and at 2, 6, and 12 weeks post-THA). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.