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

CompletedOBSERVATIONAL
Enrollment

130

Participants

Timeline

Start Date

December 10, 2018

Primary Completion Date

December 7, 2021

Study Completion Date

December 7, 2021

Conditions
Postural Stability
Interventions
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)

DIAGNOSTIC_TEST

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)

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

EuroQol Group Health questionnaire (EQ-5D-5L)

Overall health will be assessed using the EQ-5D-5L health questionnaire

DIAGNOSTIC_TEST

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).

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

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.

Trial Locations (1)

4031

Department of Orthopaedics and Traumatology, University Hospital Basel, Basel

All Listed Sponsors
lead

University Hospital, Basel, Switzerland

OTHER

NCT03860610 - TEPStabil - Muscle Function and Dynamic and Postural Stability in Patients Receiving Hip or Knee Arthroplasty | Biotech Hunter | Biotech Hunter