N/A
N=40
Early Postoperative Compex Rehab NMES Use for Total Knee Arthroplasty Patients
Knee Osteoarthritis
Bottom Line
View on ClinicalTrials.gov: NCT01844193 ↗Enrolled (actual)
40
Serious AEs
2.5%
Results posted
Apr 2021
Primary outcome: Primary: Change in Quadriceps Force — 49.0; 28.4 Newtons (N)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Compex Rehab (Device)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- All
- Sponsor
- Orthopaedic Research Foundation
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Quadriceps Force |
49.0; 28.4 | — |
| SECONDARY Change in VAS Pain Scores |
-1.06; -1.07 | — |
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, qualitative outcomes, and the impact of NMES on pain medication requests between groups. It is possible that strengthening the quadriceps muscles and improving their activation will reduce postoperative pain and help patients return to activities sooner than with standard therapy alone.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01844193). 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.