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Trial record 1 of 1 for:    NCT02945553
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Prevention of Skeletal Muscle Adaptations to Traumatic Knee Injury and Surgery

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ClinicalTrials.gov Identifier: NCT02945553
Recruitment Status : Completed
First Posted : October 26, 2016
Last Update Posted : September 6, 2019
Sponsor:
Information provided by (Responsible Party):
Michael J. Toth, Ph.D., University of Vermont

Brief Summary:
Traumatic knee injury is common and highly debilitating. Surgical reconstruction/repair improves knee biomechanics and function, but neuromuscular dysfunction persist for years despite rehabilitation, hindering resumption of normal activities, increasing risk of further injury and, in a majority of patients, hastening the development of knee osteoarthritis (OA). Our goal in this research study is to evaluate the utility of neuromuscular electrical stimulation (NMES), initiated following injury and maintained through the early post-surgical period, to prevent muscle atrophy and intrinsic contractile dysfunction compared to active control intervention of micro-electrical stimulation.

Condition or disease Intervention/treatment Phase
Anterior Cruciate Ligament Reconstruction Device: Neuromuscular electrical stimulation Device: Microstimulation Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Study Start Date : October 2016
Actual Primary Completion Date : September 2019
Actual Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: NMES
Neuromuscular electrical stimulation (NMES) group
Device: Neuromuscular electrical stimulation
Neuromuscular electrical stimulation (NMES) will be performed 5 times/week for one hour each day. NMES will start within 1 week of injury and continue till 3 weeks following surgery.

Active Comparator: Microstimulation
Microstimulation
Device: Microstimulation
Microstimulation will be performed 5 times/week for one hour each day. Microstimulation will start within 1 week of injury and continue till 3 weeks following surgery.




Primary Outcome Measures :
  1. Cross-sectional area of skeletal muscle fibers [ Time Frame: Difference between injured and non-injured leg at 3 weeks post-surgery ]
    Cross-sectional area of skeletal muscle fibers will be evaluated using immunohistochemistry, with specification of all relevant muscle fiber types

  2. Maximal calcium-activated tension single muscle fiber tension [ Time Frame: Difference between injured and non-injured leg at 3 weeks post-surgery ]
    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, with muscle fiber type determined post-measurement by gel electrophoresis

  3. Maximal single muscle fiber shortening velocity [ Time Frame: Difference between injured and non-injured leg at 3 weeks post-surgery ]
    Maximal shortening velocity from segments of chemically-skinned single human muscle fibers will be assessed, with muscle fiber type determined post-measurement by gel electrophoresis



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18-50 yrs
  • BMI <35 kg/m2
  • acute, first-time, ACL rupture with or without meniscus injury
  • scheduled to undergo reconstruction with a BPTB autograft

Exclusion Criteria:

  • history of prior knee/lower extremity surgery or non-surgical intervention (eg, intra-articular injection) on either leg
  • abnormal laxity of any lower extremity ligament other than the injured ACL
  • signs or symptoms of arthritis, autoimmune or inflammatory disease or diabetes
  • grade IIIb or greater articular cartilage lesions (ICRS criteria)
  • women who are/plan on becoming pregnant

Information from the National Library of Medicine

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): NCT02945553


Locations
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United States, Vermont
University of Vermont College of Medicine
Burlington, Vermont, United States, 05405
Sponsors and Collaborators
University of Vermont
Investigators
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Principal Investigator: Michael J. Toth, Ph.D. University of Vermont
Principal Investigator: Bruce D. Beynnon, Ph.D. University of Vermont

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Responsible Party: Michael J. Toth, Ph.D., Associate Professor of Medicine, University of Vermont
ClinicalTrials.gov Identifier: NCT02945553    
Other Study ID Numbers: M16-609
First Posted: October 26, 2016    Key Record Dates
Last Update Posted: September 6, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Research data (deidentified) which documents, supports and validates research findings will be stored on the University of Vermont College of Medicine computer system and will be made available upon final acceptance for publication of the major findings from the proposed studies. This includes raw data generated from all clinical and laboratory-based assessments under a data-sharing agreement.