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

NCT ID: NCT03860610

Last Updated: 2022-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

130 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-10

Study Completion Date

2021-12-07

Brief Summary

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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

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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.

Conditions

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Postural Stability

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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'

Muscle strength test

Intervention Type DIAGNOSTIC_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

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_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)

Intervention Type DIAGNOSTIC_TEST

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

HOOS/ KOOS

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_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

Intervention Type DIAGNOSTIC_TEST

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.

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'

Muscle strength test

Intervention Type DIAGNOSTIC_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

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_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)

Intervention Type DIAGNOSTIC_TEST

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

HOOS/ KOOS

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_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

Intervention Type DIAGNOSTIC_TEST

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.

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'

Muscle strength test

Intervention Type DIAGNOSTIC_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

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_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)

Intervention Type DIAGNOSTIC_TEST

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

HOOS/ KOOS

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_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

Intervention Type DIAGNOSTIC_TEST

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.

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'

Muscle strength test

Intervention Type DIAGNOSTIC_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

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_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)

Intervention Type DIAGNOSTIC_TEST

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

HOOS/ KOOS

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_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

Intervention Type DIAGNOSTIC_TEST

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.

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'

Muscle strength test

Intervention Type DIAGNOSTIC_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

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_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)

Intervention Type DIAGNOSTIC_TEST

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

HOOS/ KOOS

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_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

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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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)

Intervention Type 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)

Intervention Type 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.

Intervention Type DIAGNOSTIC_TEST

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

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

Intervention Type 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).

Intervention Type 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.

Intervention Type 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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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)
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Annegret Muendermann, Prof. Dr. MD

Role: PRINCIPAL_INVESTIGATOR

Department of Orthopaedics and Traumatology, University Hospital Basel

Locations

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Department of Orthopaedics and Traumatology, University Hospital Basel

Basel, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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2018-02159; ch19Muendermann

Identifier Type: -

Identifier Source: org_study_id

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