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.

Study Overview

• Status: Completed
• Conditions: Total Knee Replacement
• Intervention / Treatment: Device: Kneehab XP; Device: Quadriceps TENS

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
• Enrollment (Actual): 111
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Greenville, South Carolina, United States, 29615
      • Hawkins Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Isometric Strength Test	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.	measured at the 6 week post-operative time point

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patients With Positive PASS	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	measured at the 6 week post-operative time point

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical Therapy Sessions	Change in patient functional measures and number of therapy sessions required.	1 wk pre-operatively, 3,6,12,52 week post operatively
Questionnaires	Change in scores in patient outcome measures, functional measures and physical performance measures	1 wk pre-operatively, 3,6,12,52 week post operatively
Range of Motion	Change in scores of functional and physical performance scores	1 wk pre-operatively, 3,6,12,52 week post operatively
Timed to Get up and go	Change in scores of physical performance measures	1 wk pre-operatively, 3,6,12,52 week post operatively
Stair Climb Test	Change in scores of physical performance measures	1 wk pre-operatively, 3,6,12,52 week post operatively
Visual Analogue Scales (VAS)	Pain change score in VAS from baseline to week 6 post-surgery	1 wk pre-operatively,3,6,12 and 52 post operatively

Collaborators and Investigators

• Sponsor: Theragen Inc.
• Investigators: Principal Investigator: Brian Burnikel, Hawkins Foundation

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (ACTUAL): August 1, 2016
• Study Completion (ACTUAL): October 1, 2016

Study Registration Dates

• First Submitted: February 16, 2012
• First Submitted That Met QC Criteria: March 7, 2012
• First Posted (ESTIMATE): March 8, 2012

Study Record Updates

• Last Update Posted (ACTUAL): April 11, 2018
• Last Update Submitted That Met QC Criteria: March 16, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: strength; Muscle; NMES; TKA; Focus to show shorter muscle recovery after Knee operation
• Other Study ID Numbers: Pro00012744