Prevention of Skeletal Muscle Adaptations to Traumatic Knee Injury and Surgery

Completed · Phase 1/Phase 2

Conditions studied: Anterior Cruciate Ligament Reconstruction

In brief

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.

Key facts

Study ID

NCT02945553

Run by

University of Vermont

People needed

25

Starts

2016-10-01

Expected to finish

2019-09-01

Last updated by the study team

2021-01-05

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

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

Where it is running

• University of Vermont College of Medicine — Burlington, Vermont, United States

Full record on ClinicalTrials.gov

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