Phase 2
N=25
Prevention of Skeletal Muscle Adaptations to Traumatic Knee Injury and Surgery
Anterior Cruciate Ligament Reconstruction
Bottom Line
View on ClinicalTrials.gov: NCT02945553 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcome: Primary: Cross-sectional Area of Skeletal Muscle Fibers (All Fibers) — 2827; 3318; 2206; 2376 micrometer squared — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Neuromuscular electrical stimulation (Device); Microstimulation (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Vermont
- Primary completion
- Sep 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cross-sectional Area of Skeletal Muscle Fibers (All Fibers) |
2827; 3318; 2206; 2376 | <0.05 sig |
| PRIMARY Maximal Calcium-activated Tension Single Muscle Fiber Tension (Myosin Heavy Chain (MHC) IIA Fibers) |
127; 137; 169; 175 | — |
| PRIMARY Maximal Single Muscle Fiber Shortening Velocity (Myosin Heavy Chain (MHC) IIA Fibers) |
1.74; 1.67; 1.95; 1.92 | — |
| PRIMARY Cross-sectional Area of Skeletal Muscle Fibers (Myosin Heavy Chain (MHC) I Fibers) |
2552; 2206; 3217; 2827 | — |
| PRIMARY Cross-sectional Area of Skeletal Muscle Fibers (MHC IIA) |
2290; 2206; 3739; 3318 | — |
| SECONDARY Knee Extensor Peak Isokinetic Torque |
59.4; 66.4 | <0.05 sig |
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
Data sourced from ClinicalTrials.gov (NCT02945553). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.