CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 111 enrolled
Drug / intervention
Kneehab XP +1 moredevice
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/NCT01548040
NCT01548040N/ACompleted
CompareCT.gov

A Randomised Controlled Study To Compare the Effects of a Standard Therapy Protocol With a 12-week Peri-Operative Program of Kneehab XP Compared to a Control Treatment in Patients Undergoing Total Knee Replacement

Theragen Inc.·interventional·Posted Mar 8, 2012·Updated Apr 11, 2018

In Brief

A clinical study evaluating Kneehab XP and Quadriceps TENS for Total Knee Replacement. Completed, enrolled 111 participants across 1 site.

Detailed Summary

The study is a prospective, randomized, double-blind sham study of TKA patients who receive a standard peri-operative treatment program plus Kneehab XP versus a standard peri-operative treatment program plus a sham device.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTotal Knee Replacement
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 8, 2012
Enrollment StartMar 1, 2012
Primary CompletionAug 1, 2016
Study CompletionOct 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 14.3 years ago

Interventions

Kneehab XPdevice

NMES using Kneehab XP on the affected leg,20 minutes, twice per day, 5 days a week. Subjects will begin use of the device at 6 weeks pre-operatively and continue through 6 weeks post-operatively

Quadriceps TENSdevice

on the affected leg, 20 minutes, twice per days, 5 days a week. Subjects will begin use of the device at 6 weeks pre-operatively and continue through 6 weeks post-operatively.