Prevention of Skeletal Muscle Adaptations to Traumatic Knee Injury and Surgery

Anterior Cruciate Ligament Reconstruction Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02945553
• Other study ID #: M16-609
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: October 2016
• Est. completion date: September 2019

Study information

• Verified date: November 2020
• Source: University of Vermont
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: September 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Reconstruction

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Vermont College of Medicine	Burlington	Vermont

Sponsors (1)

Lead Sponsor	Collaborator
University of Vermont

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Knee Extensor Peak Isokinetic Torque	Peak isokinetic torque is measures in injured and non-injurd leg at 60 deg/s using dynamometry	Difference between injured and non-injured leg at 6 months post-surgery