Skeletal Muscle Atrophy and Dysfunction Following Total Knee Arthroplasty
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|ClinicalTrials.gov Identifier: NCT03051984|
Recruitment Status : Recruiting
First Posted : February 14, 2017
Last Update Posted : November 4, 2020
|Condition or disease||Intervention/treatment||Phase|
|Knee Osteoarthritis||Device: Neuromuscular electrical stimulation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Skeletal Muscle Atrophy and Dysfunction Following Total Knee Arthroplasty|
|Actual Study Start Date :||January 1, 2017|
|Estimated Primary Completion Date :||June 30, 2021|
|Estimated Study Completion Date :||June 30, 2021|
Neuromuscular electrical stimulation (NMES) will be administered for 5 weeks post-TKA in the quadriceps of the surgical leg. Treatment will occur 5 days per week, twice daily for 45 minutes on each occasion.
Device: Neuromuscular electrical stimulation
NMES will be conducted on the quadriceps of the operative leg using a portable stimulation device, starting within 48-72 hrs of surgery. The operative leg will be immobilized at a neutral angle (~30º), with electrodes affixed to the anterior surface of the thigh. Symmetrical, biphasic pulses (400 µs duration at 50 Hz) will be used, with a duty cycle of 25% (10 s on, 30 s off), with patient-selected stimulation intensity to cause visible contractions below pain threshold. NMES sessions will occur 5 d/week, twice daily for 45 min (5 min warm-up) for 5 wks.
Other Name: NMES
No Intervention: Control
No intervention will be administered during the 5 weeks post-TKA in the surgical leg.
- Cross-sectional area of muscle fibers [ Time Frame: Change from baseline cross-sectional area at 5 weeks ]Cross-sectional area of skeletal muscle fibers will be evaluated using immunohistochemistry, with specification of all relevant muscle fiber types
- Intermyofibrillar mitochondrial content [ Time Frame: Change from baseline cross-sectional area at 5 weeks ]Area fraction of intermyofibrillar mitochondria will be assessed by electron microscopy
- Maximal calcium-activated tension single muscle fiber tension and shortening velocity [ Time Frame: Change from baseline cross-sectional area at 5 weeks ]Tension (force per unit muscle fiber cross-sectional area) from segments of chemically-skinned single human muscle fibers will be assessed under maximal calcium-activated condition and shortening velocity will be evaluated from isotonic load clamps, with muscle fiber type determined post-measurement by gel electrophoresis
- Mitochondrial function [ Time Frame: Change from baseline cross-sectional area at 5 weeks ]Oxygen consumption rate of isolated muscle mitochondria under adenosine diphosphate stimulation and hydrogen peroxide production
- Physical activity level [ Time Frame: Change from baseline cross-sectional area at 5 weeks ]Physical activity will be assessed by accelerometry.
- Quadriceps muscle cross-sectional area [ Time Frame: Change from baseline cross-sectional area at 5 weeks ]Quadriceps muscle cross-sectional area will be assessed by computed tomography at the mid-thigh.
- Physical functional measures [ Time Frame: Change from baseline cross-sectional area at 5 weeks ]Whole body physical function will be assessed.
- Whole muscle strength [ Time Frame: Change from baseline cross-sectional area at 5 weeks ]Knee extensor isometric and isokinetic strength will be assessed by dynamometry.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03051984
|Contact: Michael J Toth, PhDfirstname.lastname@example.org|
|Contact: Patrick Savageemail@example.com|
|United States, Vermont|
|University of Vermont College of Medicine||Recruiting|
|Burlington, Vermont, United States, 05405|
|Contact: Patrick Savage 802-847-4545 firstname.lastname@example.org|