Brief Summary

Study 1 is to determine if muscle strength and dynamic and postural stability are compromised in patients with severe hip or knee Osteoarthritis (OA) and in patients after THA and TKA. Study 2 is to quantify the effect of THA and TKA on muscle strength and dynamic and postural stability.

Trial Health

On Track

Trial Health Score

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

Enrollment

130

participants targeted

Target at P50-P75 for all trials

Timeline

Completed

Started Dec 2018

Typical duration for all trials

Geographic Reach

1 country

1 active site

Status

completed

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

3 years study duration

Study Start

First participant enrolled

December 10, 2018

Completed

3 months until next milestone

First Submitted

Initial submission to the registry

February 26, 2019

Completed

6 days until next milestone

First Posted

Study publicly available on registry

March 4, 2019

Completed

2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 7, 2021

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 7, 2021

Completed

Last Updated

March 4, 2022

Status Verified

March 1, 2022

Enrollment Period

3 years

First QC Date

February 26, 2019

Last Update Submit

March 3, 2022

Conditions

Postural Stability

Keywords

Total Hip ArthroplastyTotal Knee ArthroplastyOsteoarthritisMuscle strength deficitsDynamic stability

Outcome Measures

Primary Outcomes (6)

Muscle strength (Study 1)
For the knee, maximum isokinetic flexion and extension torques will be collected between full extension and 90° flexion at a movement speed of 60°/s (5 repetitions) and 240°/s (5 repetitions).For the hip, maximum abduction torques will be measured isometrically (5 repetitions) in a standing position. Maximum joint torques in each movement direction will be recorded for each joint and normalized to body weight (study group 1 to 5)
single point measurement at Visit A (week 0)
Change in Muscle strength (Study 2)
For the knee, maximum isokinetic flexion and extension torques will be collected between full extension and 90° flexion at a movement speed of 60°/s (5 repetitions) and 240°/s (5 repetitions).For the hip, maximum abduction torques will be measured isometrically (5 repetitions) in a standing position. Maximum joint torques in each movement direction will be recorded for each joint and normalized to body weight (study group 3 and 4)
Three assessments will be performed: preoperatively (visit 1), 6 weeks postoperatively (visit 2) and 1 year postoperative (visit 3).
Postural stability (Study 1)
The overall stability index (OSI) will be assessed using the Biodex Balance System SD. A high stability index represents the angular excursion of the subject's center of gravity and is indicative of a high degree of movement during a test (i.e.poor balance). (study group 1 to 5)
single point measurement at Visit A (week 0)
Change in postural stability (Study 2)
The overall stability index (OSI) will be assessed using the Biodex Balance System SD. A high stability index represents the angular excursion of the subject's center of gravity and is indicative of a high degree of movement during a test (i.e.poor balance).(study group 3 and 4)
Three assessments will be performed: preoperatively (visit 1), 6 weeks postoperatively (visit 2) and 1 year postoperative (visit 3).
Dynamic stability (Study 1)
Instrumented gait analysis on an overground walkway to compute step width for each step from a pressure plate built into the treadmill (study group 1 to 5)
single point measurement at Visit A (week 0)
Change in dynamic stability (Study 2)
Instrumented gait analysis on an overground walkway to compute step width for each step from a pressure plate built into the treadmill (study group 3 and 4)
Three assessments will be performed: preoperatively (visit 1), 6 weeks postoperatively (visit 2) and 1 year postoperative (visit 3).

Study Arms (5)

Patient group 1 after THA

Patients who have already received a THA (N=30) for OA will be assessed 1 year postoperatively (Visit A); Interventions in this Group: 'Muscle strength test', 'Dynamic stability test during level and uphill walking', 'Postural stability test', 'EuroQol Group Health questionnaire (EQ-5D-5L)', 'HOOS/ KOOS', ' Muscle activity test', 'Passive range of motion'

Diagnostic Test: Muscle strength testDiagnostic Test: Dynamic stability test during level and uphill walkingDiagnostic Test: Postural stability testDiagnostic Test: EuroQol Group Health questionnaire (EQ-5D-5L)Diagnostic Test: HOOS/ KOOSDiagnostic Test: Muscle activity testDiagnostic Test: Passive range of motion

Patient group 2 after TKA

Patients who have already received a TKA (N=30) for OA will be assessed 1 year postoperatively (Visit A); Interventions in this Group: 'Muscle strength test', 'Dynamic stability test during level and uphill walking', 'Postural stability test', 'EuroQol Group Health questionnaire (EQ-5D-5L)', 'HOOS/ KOOS', ' Muscle activity test', 'Passive range of motion'

Patient group 3 before THA

Patients with severe hip OA (N=30) scheduled to receive a THA will be assessed preoperatively (Visit 1), 12 weeks postoperative (Visit 2) and 1 year postoperative (Visit 3). Interventions in this Group: 'Muscle strength test', 'Dynamic stability test during level and uphill walking', 'Postural stability test', 'EuroQol Group Health questionnaire (EQ-5D-5L)', 'HOOS/ KOOS', ' Muscle activity test', 'Passive range of motion'

Patient group 4 before TKA

Patients with severe knee OA (N=30) scheduled to receive a TKA will be assessed preoperatively (Visit 1), 12 weeks postoperative (Visit 2) and 1 year postoperative (Visit 3). Interventions in this Group: 'Muscle strength test', 'Dynamic stability test during level and uphill walking', 'Postural stability test', 'EuroQol Group Health questionnaire (EQ-5D-5L)', 'HOOS/ KOOS', ' Muscle activity test', 'Passive range of motion'

Healthy control group

Age-matched healthy control subjects (N=30);Interventions in this Group: 'Muscle strength test', 'Dynamic stability test during level and uphill walking', 'Postural stability test', 'EuroQol Group Health questionnaire (EQ-5D-5L)', 'HOOS/ KOOS', ' Muscle activity test', 'Passive range of motion'

Interventions

Muscle strength testDIAGNOSTIC_TEST

Muscle strength in knee flexion and extension and hip abduction will be tested using using a dynamometer (Biodex System 4 Pro: Biodex Medical Systems, Shirley, NY, USA)