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Clinical Trials/NCT02945553
NCT02945553
Completed
Phase 1

Prevention of Skeletal Muscle Adaptations to Traumatic Knee Injury and Surgery

University of Vermont1 site in 1 country25 target enrollmentOctober 2016

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Anterior Cruciate Ligament Reconstruction
Sponsor
University of Vermont
Enrollment
25
Locations
1
Primary Endpoint
Cross-sectional Area of Skeletal Muscle Fibers (All Fibers)
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2016
End Date
September 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Michael J. Toth, Ph.D.

Associate Professor of Medicine

University of Vermont

Eligibility 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

Outcomes

Primary Outcomes

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

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

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

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

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

Secondary Outcomes

  • Knee Extensor Peak Isokinetic Torque(Difference between injured and non-injured leg at 6 months post-surgery)

Study Sites (1)

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