Prevention of Skeletal Muscle Adaptations to Traumatic Knee Injury and Surgery

Phase 1

Completed

• Conditions: Anterior Cruciate Ligament Reconstruction
• Interventions: Device: Neuromuscular electrical stimulation; Device: Microstimulation

• Registration Number: NCT02945553
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-10-24
• Study First Submitted QC: 2016-10-24
• Study First Posted: 2016-10-26
• Primary Completion: 2019-09
• Study Completion: 2019-09
• Status Verified: 2020-11
• Results First Submitted: 2020-11-12
• Results First Submitted QC: 2021-01-01
• Last Update Submitted: 2021-01-01
• Results First Posted: 2021-01-05
• Last Update Posted: 2021-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NMES	Neuromuscular electrical stimulation	Neuromuscular electrical stimulation (NMES) group
Microstimulation	Microstimulation	Microstimulation

Primary Outcome Measures

Name	Time	Method
Cross-sectional Area of Skeletal Muscle Fibers (All Fibers)	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)	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)	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)	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)	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 Outcome Measures

Name	Time	Method
Knee Extensor Peak Isokinetic Torque	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

Trial Locations

Locations (1)

University of Vermont College of Medicine; 🇺🇸 Burlington, Vermont, United States