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Controlled Study of Kneehab XP for Patients Undergoing Total Knee Replacement

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ClinicalTrials.gov Identifier: NCT01548040
Recruitment Status : Completed
First Posted : March 8, 2012
Results First Posted : March 19, 2018
Last Update Posted : April 11, 2018
Sponsor:
Information provided by (Responsible Party):
Theragen Inc.

February 16, 2012
March 8, 2012
December 5, 2017
March 19, 2018
April 11, 2018
March 2012
August 2016   (Final data collection date for primary outcome measure)
Isometric Strength Test [ Time Frame: measured at the 6 week post-operative time point ]
To determine the efficacy of Kneehab XP in promoting early quadriceps strength improvement (measured as the difference between the baseline time point and the 6 week post-operative time point) when compared to a control group in patients undergoing total knee arthroplasty. Isometric strength was measured using a Biodex Isokinetic Dynamometer machine on patients seated and secured to a chair and who performed 3 maximal voluntary contractions (MVC) for which the maximal torque is measured and a mean taken of 3 consecutive MVC's.
Isometric Strength Test [ Time Frame: measured at the 6 week post-operative time point ]
To determine the efficacy of Kneehab XP in promoting early quadriceps strength improvement (measured at the 6 week post-operative time point) when compared to a control group in patients undergoing total knee arthroplasty.
Complete list of historical versions of study NCT01548040 on ClinicalTrials.gov Archive Site
Percentage of Patients With Positive PASS [ Time Frame: measured at the 6 week post-operative time point ]
To determine whether Kneehab XP leads to earlier recovery (measured at the 6 week post-operative time point) when compared to a control group in patients undergoing total knee arthroplasty. Patient Acceptable Symptom State (PASS) is a yes/no answer to a specifically stated question about the patients satisfaction with their state. For clarity, Positive PASS implies that the answer that is given is Positive i.e. Yes
  • Positive PASS [ Time Frame: measured at the 6 week post-operative time point ]
    to determine whether Kneehab XP leads to earlier recovery (measured at the 6 week post-operative time point) when compared to a control group in patients undergoing total knee arthroplasty.
  • Visual Analogue Scales [ Time Frame: 1 wk pre-operatively,3,6,12 and 52 post operatively ]
    Pain change score
  • Stair Climb Test [ Time Frame: 1 wk pre-operatively, 3,6,12,52 week post operatively ]
    Change in scores of physical performance measures
  • Timed to get up and go [ Time Frame: 1 wk pre-operatively, 3,6,12,52 week post operatively ]
    Change in scores of physical performance measures
  • Range of Motion [ Time Frame: 1 wk pre-operatively, 3,6,12,52 week post operatively ]
    Change in scores of functional and physical performance scores
  • Questionnaires [ Time Frame: 1 wk pre-operatively, 3,6,12,52 week post operatively ]
    Change in scores in patient outcome measures, functional measures and physical performance measures
  • Physical Therapy sessions [ Time Frame: 1 wk pre-operatively, 3,6,12,52 week post operatively ]
    Change in patient functional measures and number of therapy sessions required.
  • Physical Therapy Sessions [ Time Frame: 1 wk pre-operatively, 3,6,12,52 week post operatively ]
    Change in patient functional measures and number of therapy sessions required.
  • Questionnaires [ Time Frame: 1 wk pre-operatively, 3,6,12,52 week post operatively ]
    Change in scores in patient outcome measures, functional measures and physical performance measures
  • Range of Motion [ Time Frame: 1 wk pre-operatively, 3,6,12,52 week post operatively ]
    Change in scores of functional and physical performance scores
  • Timed to Get up and go [ Time Frame: 1 wk pre-operatively, 3,6,12,52 week post operatively ]
    Change in scores of physical performance measures
  • Stair Climb Test [ Time Frame: 1 wk pre-operatively, 3,6,12,52 week post operatively ]
    Change in scores of physical performance measures
  • Visual Analogue Scales (VAS) [ Time Frame: 1 wk pre-operatively,3,6,12 and 52 post operatively ]
    Pain change score in VAS from baseline to week 6 post-surgery
Not Provided
 
Controlled Study of Kneehab XP for Patients Undergoing Total Knee Replacement
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
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.
The study is a double-blind randomized controlled clinical trial of approximately 118 patients (males and females) who are at least 40 years of age, who are scheduled for Total Knee Arthroplasty (TKA) surgery will be randomized into 1) a treatment group who receive Kneehab XP and a standard rehabilitation program and 2) a control group who receive only a sham device and a standard rehabilitation program. Patients are tracked for measures of function, pain, quality of life, physical performance and acceptable states status at 6 weeks and 1 week before surgery and 3, 6, 12, and 52 weeks following surgery.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Total Knee Replacement
  • Device: Kneehab XP
    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
  • Device: Quadriceps TENS
    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.
  • Experimental: quadriceps NMES using Kneehab XP
    All subjects in the treatment group will receive quadriceps Neuro Muscular Electrical Stimulation (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.group will also complete the standard TKA post-surgery rehabilitation program used at the Hawkins Foundation
    Intervention: Device: Kneehab XP
  • Sham Comparator: quadriceps TENS
    The sham device will look identical to the Kneehab XP device. All subjects in the control group will receive quadriceps Transcutaneous Electrical Nerve Stimulation (TENS) at a minimal sensory input using Kneehab XP 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.group will also complete the standard TKA post-surgery rehabilitation program used at the Hawkins Foundation
    Intervention: Device: Quadriceps TENS
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
111
118
October 2016
August 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Individuals who are scheduled for Total Knee Replacement surgery with the Smith and Nephew Visionaire prosthesis and the anterior surgical approach.
  • Individuals who are at least 40 years of age.
  • Individuals with a body mass index (BMI) <40 kg/ m2
  • Individuals who are walking independently with or without assistive devices.
  • Individuals with a Short Performance Battery Score greater than 7.
  • Must be able and willing to complete all study assessments and to be followed for the full course of the study.
  • Must be able to read, write and follow instructions in English.
  • Must be able and willing to provide informed consent.
  • Must be willing and able to attend the additional pre-operative assessment.

Exclusion Criteria:

  • Individuals with a history of foot and/or ankle pathology.
  • Individuals with a history of tibial or femoral fractures.
  • Individuals with a history of any underlying neurological conditions.
  • Individuals with physical conditions which would make them unable to perform study procedures.
  • Individuals with a total hip replacement.
  • Individuals undergoing revision TKA of the same operated leg.
  • Individuals who are pregnant.
  • Individuals diagnosed with a medical condition that would contraindicate treatment with the product, e.g. skin lesions at electrode site.
  • Individuals with an active implanted medical device (i.e. pacemaker, pump)
  • Individuals with a history of stroke
  • Individuals with a history of neurological disorder that affects lower extremity function (stroke, peripheral neuropathy, Parkinson's disease, multiple sclerosis, etc.)
  • Individuals with a diagnosis of inflammatory arthritis (Rheumatoid arthritis, gout or psoriatic arthritis).
  • Individuals with muscle diseases (i.e. muscular dystrophy)
  • Individuals with visible skin injury or disease on their legs.
  • Individuals who have been committed to an institution by virtue of an order issued either by the courts or by an authority.
Sexes Eligible for Study: All
40 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01548040
Pro00012744
No
Not Provided
Not Provided
Theragen Inc.
Theragen Inc.
Not Provided
Principal Investigator: Brian Burnikel Hawkins Foundation
Theragen Inc.
March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP