CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 60 enrolled
Drug / intervention
Compex Rehabdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01844193
NCT01844193N/ACompleted

A 12-Month Prospective, Post-Market Study of Early Postoperative Compex® Rehab NMES Use in Total Knee Arthroplasty Patients

Orthopaedic Research Foundation·interventional·Posted May 1, 2013·Updated Apr 12, 2021

In Brief

A clinical study evaluating Compex Rehab for Knee Osteoarthritis. Completed, enrolled 60 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsDJO Incorporated

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMay 1, 2013
Enrollment StartJan 1, 2013
Primary CompletionDec 31, 2016
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 13.2 years ago

Interventions

Compex Rehabdevice

Participants in this arm will use a Compex® Rehab unit for neuromuscular electrical stimulation starting with postoperative at-home day 1 and continue using the unit twice a day, every day, until a 10-week follow-up is reached. The unit produces a 380 microsecond biphasic curve and utilizes a four phase process for the treatment ("Warm-up", "Work", "Relaxation", and "Recovery") for a total treatment time of 20 minutes and 5 seconds per session. All frequencies are delivered at the maximum subjective tolerable intensity. Participants will control this intensity and be asked to select a level that is tolerable although mildly uncomfortable; they will be instructed to increase this intensity as tolerated.