Status:
COMPLETED
Early Postoperative Compex Rehab NMES Use for Total Knee Arthroplasty Patients
Lead Sponsor:
Orthopaedic Research Foundation
Collaborating Sponsors:
DJO Incorporated
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
45-75 years
Phase:
NA
Brief Summary
This study will examine the effects, if any, of using muscle stimulation on the quadriceps following a total knee replacement. Secondary objectives will be to evaluate and compare pain levels, qualita...
Detailed Description
Neuromuscular electrical stimulation (NMES) for muscle strengthening and training has been in use since the 1970s, but questions still remain regarding its effectiveness with different patient populat...
Eligibility Criteria
Inclusion
- Patient is a candidate for unilateral primary total knee arthroplasty and has a primary diagnosis of osteoarthritis.
- Patient is a male or non-pregnant female age 18 and older at time of surgery.
- Patient has signed an Institutional review board (IRB)-approved, study-specific informed consent form.
- Patient is willing and able to comply with the postoperative scheduled clinical evaluations and rehabilitation.
Exclusion
- Patient has active infection within the affected knee joint.
- Patient requires revision surgery of a previously implanted total knee arthroplasty.
- Patient is morbidly obese, defined as having a body mass index (BMI) greater than or equal to 36.
- Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the intervention.
- Patient has been diagnosed with a systemic disease or current life threatening illness and is not able to carry on normal activities of daily life (e.g. Paget's disease, renal osteodystrophy, etc.).
- Patient has a history of cardiac issues including myocardial infarction and/or has a pacemaker.
- Patient is immunologically suppressed or receiving chronic steroids in excess of 5mg per day.
- Patient has a recent history of substance dependency that may result in deviations from the evaluation schedule.
- Patient is a prisoner.
- Patient has indication for contralateral total knee arthroplasty within the evaluation window.
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2016
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01844193
Start Date
January 1 2013
End Date
December 31 2016
Last Update
April 12 2021
Active Locations (1)
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1
OrthoIndy
Greenwood, Indiana, United States, 46143