Clinical trial NCT02945553: Prevention of Skeletal Muscle Adaptations to Traumatic Knee Injury and Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Anterior Cruciate Ligament Reconstruction
Lead sponsor: University of Vermont
Sponsor class: OTHER
First posted: 2016-10-26
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Cross-sectional Area of Skeletal Muscle Fibers (All Fibers)
timeFrame: Difference between injured and non-injured leg at 3 weeks post-surgery
measure: Maximal Calcium-activated Tension Single Muscle Fiber Tension (Myosin Heavy Chain (MHC) IIA Fibers)
timeFrame: Difference between injured and non-injured leg at 3 weeks post-surgery
measure: Maximal Single Muscle Fiber Shortening Velocity (Myosin Heavy Chain (MHC) IIA Fibers)
timeFrame: Difference between injured and non-injured leg at 3 weeks post-surgery
measure: Cross-sectional Area of Skeletal Muscle Fibers (Myosin Heavy Chain (MHC) I Fibers)
timeFrame: Difference between injured and non-injured leg at 3 weeks post-surgery
measure: Cross-sectional Area of Skeletal Muscle Fibers (MHC IIA)
timeFrame: Difference between injured and non-injured leg at 3 weeks post-surgery
Secondary outcomes:
measure: Knee Extensor Peak Isokinetic Torque
timeFrame: Difference between injured and non-injured leg at 6 months post-surgery
Other outcomes:
Locations:
city: Burlington
country: United States
facility: University of Vermont College of Medicine
state: Vermont
Study officials:
affiliation: University of Vermont
name: Michael J. Toth, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Vermont
name: Bruce D. Beynnon, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.