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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.

Brief 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.

Condition or disease Intervention/treatment Phase
Total Knee Replacement Device: Kneehab XP Device: Quadriceps TENS Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 111 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2012
Actual Primary Completion Date : August 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement
U.S. FDA Resources

Arm Intervention/treatment
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
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
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
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. 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.

  2. 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

  3. 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

  4. 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

  5. Stair Climb Test [ Time Frame: 1 wk pre-operatively, 3,6,12,52 week post operatively ]
    Change in scores of physical performance measures

  6. 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



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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01548040


Locations
United States, South Carolina
Hawkins Foundation
Greenville, South Carolina, United States, 29615
Sponsors and Collaborators
Theragen Inc.
Investigators
Principal Investigator: Brian Burnikel Hawkins Foundation

Responsible Party: Theragen Inc.
ClinicalTrials.gov Identifier: NCT01548040     History of Changes
Other Study ID Numbers: Pro00012744
First Posted: March 8, 2012    Key Record Dates
Results First Posted: March 19, 2018
Last Update Posted: April 11, 2018
Last Verified: March 2018

Keywords provided by Theragen Inc.:
NMES
Muscle
strength
TKA
Focus to show shorter muscle recovery after Knee operation