Prevention of Skeletal Muscle Adaptations to Traumatic Knee Injury and Surgery
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
25 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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