Changes in Postural Stability Following THA for OA
ConditionOsteoarthritis, Hip
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age60+
SponsorWestern University, Canada
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥ 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
Disqualifiers
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 population
People receiving elective unilateral total hip arthroplasty for osteoarthritis
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Total Hip Arthroplasty
Procedure/SurgeryTotal hip arthroplasty is a common surgical procedure performed in people with advanced hip osteoarthritis
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Direct Anterior1 intervention
Group B: Direct Lateral1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Pre-THA, and at 2, 6, and 12 weeks post-THA2
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.
Time frame
Pre-THA, and at 2, 6, and 12 weeks post-THASecondary outcomes
1
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.
Time frame
Pre-THA, and at 2, 6, and 12 weeks post-THA2
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.
Time frame
Pre-THA, and at 2, 6, and 12 weeks post-THA3
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).
Time frame
Pre-THA, and at 2, 6, and 12 weeks post-THA4
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.
Time frame
Pre-THA, and at 2, 6, and 12 weeks post-THASponsors and contacts
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Source ClinicalTrials.gov