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Completed

NCT Number: NCT02945553

Prevention of Skeletal Muscle Adaptations to Traumatic Knee Injury and Surgery

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.

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Key information

Conditions

Anterior Cruciate Ligament Reconstruction

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Vermont College of Medicine

Burlington, Vermont, 05405, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neuromuscular Electrical Stimulation

Device

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.

Microstimulation

Device

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 outcomes

  1. Cross-sectional Area of Skeletal Muscle Fibers (All 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 (Myosin Heavy Chain (MHC) IIA Fibers)

    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 (Myosin Heavy Chain (MHC) IIA Fibers)

    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

  4. Cross-sectional Area of Skeletal Muscle Fibers (Myosin Heavy Chain (MHC) I 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

  5. Cross-sectional Area of Skeletal Muscle Fibers (MHC IIA)

    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

Secondary outcomes

  1. Knee Extensor Peak Isokinetic Torque

    Time frame: Difference between injured and non-injured leg at 6 months post-surgery

    Peak isokinetic torque is measures in injured and non-injurd leg at 60 deg/s using dynamometry

Sponsors and collaborators

Lead sponsor

University of Vermont

Other

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Oct 26, 2016
Registry last updated
Jan 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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