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Completed

NCT Number: NCT01548040

Controlled Study of Kneehab XP for 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.

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Key information

Conditions

Total Knee Replacement

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hawkins Foundation

Greenville, South Carolina, 29615, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Kneehab XP

Device

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 TENS

Device

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 outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Theragen Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Mar 8, 2012
Registry last updated
Apr 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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