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

Postural Stability Clinical Trial

— TEPStabil  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03860610
• Other study ID #: 2018-02159; ch19Muendermann
• Status: Completed
• Start date: December 10, 2018
• Est. completion date: December 7, 2021

Study information

• Verified date: March 2022
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: December 7, 2021
• Est. primary completion date: December 7, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Postural Stability

Intervention

Diagnostic Test:
• Muscle strength 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)
• Dynamic stability test during level and uphill walking
Instrumented gait analysis on an overground walkway with two embedded force plates (Kistler force plate 9260AA6, Kistler AG, Winterthur, Switzerland; sampling rate 2400 Hz) and on a treadmill with an embedded plantar pressure plate (h/p/cosmos, Zebris FDM-T, Isny, Germany)
• Postural stability test
The overall stability index (OSI) will be assessed using the Biodex Balance System SD (Biodex Medical Systems, Inc., Shirley, NY, USA) and is determined by the variance in platform displacement from the horizontal plane.
• EuroQol Group Health questionnaire (EQ-5D-5L)
Overall health will be assessed using the EQ-5D-5L health questionnaire
• HOOS/ KOOS
Site specific pain and function will be assessed with the Hip Osteoarthritis Outcome Score (HOOS) and Knee Injury and Osteoarthritis Outcome Score (KOOS) depending on the affected joint (hip or knee).
• Muscle activity test
Surface electrodes (Ag/AgCl, Noraxon, U.S.A. Inc., Scottsdale, AZ, USA: 10 mm diameter, 22 mm inter-electrode distance) will be placed bilaterally on glutaeus medius, vastus medialis, semitendinosus, tibialis anterior, gastrocnemius medialis, and peroneus longus muscles. Periods of muscle activity will be defined as intensity above 2 Standard Deviation (SD) of the resting Electromyography (EMG) signal. Duration of overlapping muscle activity between agonists and antagonists normalized to one gait cycle or of a balance test, respectively, will be determined.
• Passive range of motion
Passive range of motion will be assessed for ankle plantar-/dorsiflexion, knee flexion/extension and hip flexion/extension, ab/adduction, internal/external rotation using goniometers and recorded in degrees. The range between two maxima will be recorded.

Locations

Country	Name	City	State
Switzerland	Department of Orthopaedics and Traumatology, University Hospital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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).
Primary	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)
Primary	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).
Primary	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)
Primary	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).