TEPStabil - Muscle Function and Dynamic and Postural Stability in Patients Receiving Hip or Knee Arthroplasty

Completed

• Conditions: Postural Stability

• Registration Number: NCT03860610
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Detailed Description

Postural stability is defined as the ability to maintain the body's centre of gravity within the limits of stability as determined by the base of support. It is further divided in static and dynamic stability involving the ability of maintaining a base of support while standing or completing a functional Task. The importance of postural stability is accepted as a factor predicting falls and affecting the ability to perform activities of daily living.

Despite of reported strength deficits and the importance of balance, to date the potential contribution of strength deficits in patients before and after Total Hip Arthroplasty (THA) or Total Knee Arthroplasty (TKA) to compromised balance ability is unknown. Furthermore, the role of preoperative muscle function on functional outcome of THA and TKA is poorly understood. A correlation between compromised preoperative muscular function and postoperative outcome would suggest that preoperative physical therapy may be critical for preserving the muscular status and may help explain reported poorer outcome after late treatment when muscular function has already deteriorated.

The project includes two studies differing in design and primary and secondary objectives but with overlapping patient populations.

Study 1 will include all five groups, and there is only one visit by the participant (visit A).

Study 2 will include only patients from groups 3 and 4. Three assessments will be performed: preoperatively (visit 1), 6 weeks postoperatively (visit 2) and 1 year postoperative (visit 3). Visit 1 will be identical to visit A in study 1 in these two patient groups.

Study Timeline

• Study Start: 2018-12-10
• Study First Submitted: 2019-02-26
• Study First Submitted QC: 2019-02-26
• Study First Posted: 2019-03-04
• Primary Completion: 2021-12-07
• Study Completion: 2021-12-07
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-03
• Last Update Posted: 2022-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

• Patients with an unilateral THA or TKA, which they received for the treatment of osteoarthritis (Patient groups 1+2)
• Patients diagnosed with unilateral OA of the knee or hip planned for a treatment with THA or TKA (Patient groups 3+4)
• Age ≥ 30 years (Healthy control group)

Exclusion Criteria

• Body mass index > 35kg/m2
• Use of walking aids
• Neuromuscular disorders affecting gait
• Inability to follow procedures due to psychological disorders or dementia
• Diagnosed hip or knee OA (Healthy control group)
• Current pain in the lower extremities or lower back (Healthy control group)
• Rheumatoid Arthritis (Healthy control group)
• Previous corrective osteotomy (Healthy control group)
• Regular intake of pain medication (more than 4 times per week) (Healthy control group)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postural stability (Study 1)	single point measurement at Visit A (week 0)	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)
Change in Muscle strength (Study 2)	Three assessments will be performed: preoperatively (visit 1), 6 weeks postoperatively (visit 2) and 1 year postoperative (visit 3).	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)
Muscle strength (Study 1)	single point measurement at Visit A (week 0)	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)
Dynamic stability (Study 1)	single point measurement at Visit A (week 0)	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)
Change in dynamic stability (Study 2)	Three assessments will be performed: preoperatively (visit 1), 6 weeks postoperatively (visit 2) and 1 year postoperative (visit 3).	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)
Change in postural stability (Study 2)	Three assessments will be performed: preoperatively (visit 1), 6 weeks postoperatively (visit 2) and 1 year postoperative (visit 3).	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)

Trial Locations

Locations (1)

Department of Orthopaedics and Traumatology, University Hospital Basel; 🇨🇭 Basel, Switzerland