Prevention of Skeletal Muscle Adaptations to Traumatic Knee Injury and Surgery

NCT02945553 | Completed Phase 1 Results DMC

• 1 other identifier: M16-609
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Anterior Cruciate Ligament Reconstruction

Outcome Measures

Primary Outcomes (5)

• Cross-sectional Area of Skeletal Muscle Fibers (All Fibers)

  Cross-sectional area of skeletal muscle fibers will be evaluated using immunohistochemistry, with specification of all relevant muscle fiber types

  Difference between injured and non-injured leg at 3 weeks post-surgery

• Maximal Calcium-activated Tension Single Muscle Fiber Tension (Myosin Heavy Chain (MHC) IIA Fibers)

  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

  Difference between injured and non-injured leg at 3 weeks post-surgery

• Maximal Single Muscle Fiber Shortening Velocity (Myosin Heavy Chain (MHC) IIA Fibers)

  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

  Difference between injured and non-injured leg at 3 weeks post-surgery

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

  Cross-sectional area of skeletal muscle fibers will be evaluated using immunohistochemistry, with specification of all relevant muscle fiber types

  Difference between injured and non-injured leg at 3 weeks post-surgery

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

  Cross-sectional area of skeletal muscle fibers will be evaluated using immunohistochemistry, with specification of all relevant muscle fiber types

  Difference between injured and non-injured leg at 3 weeks post-surgery

Secondary Outcomes (1)

• Knee Extensor Peak Isokinetic Torque

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

Study Arms (2)

NMES

EXPERIMENTAL

Neuromuscular electrical stimulation (NMES) group

Device: Neuromuscular electrical stimulation

Microstimulation

ACTIVE COMPARATOR

Microstimulation

Device: Microstimulation

Interventions

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.

NMES

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.

Microstimulation

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Vermont: lead

Study Sites (1)

University of Vermont College of Medicine

Burlington, Vermont, 05405, United States

Location

Related Publications (1)

• Toth MJ, Tourville TW, Voigt TB, Choquette RH, Anair BM, Falcone MJ, Failla MJ, Stevens-Lapslaey JE, Endres NK, Slauterbeck JR, Beynnon BD. Utility of Neuromuscular Electrical Stimulation to Preserve Quadriceps Muscle Fiber Size and Contractility After Anterior Cruciate Ligament Injuries and Reconstruction: A Randomized, Sham-Controlled, Blinded Trial. Am J Sports Med. 2020 Aug;48(10):2429-2437. doi: 10.1177/0363546520933622. Epub 2020 Jul 6.

  PMID: 32631074 DERIVED

Results Point of Contact

• Title: Michael Toth
• Organization: University of Vermont College of Medicine

michael.toth@med.uvm.edu

802-656-7989

Study Officials

• Michael J. Toth, Ph.D.

  University of Vermont

  PRINCIPAL INVESTIGATOR

• Bruce D. Beynnon, Ph.D.

  University of Vermont

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: October 24, 2016
• First Posted: October 26, 2016
• Study Start: October 1, 2016
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: January 5, 2021
• Results First Posted: January 5, 2021

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)