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Is There an Alternative to Immediate Home Physical Therapy Following Total Knee Arthroplasty

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ClinicalTrials.gov Identifier: NCT04060251
Recruitment Status : Suspended (COVID-19 limitations on recruitment)
First Posted : August 19, 2019
Last Update Posted : December 24, 2020
Sponsor:
Collaborator:
CyMedica Orthopedics, Inc
Information provided by (Responsible Party):
Wolfgang Fitz, M.D., Brigham and Women's Hospital

Tracking Information
First Submitted Date  ICMJE April 3, 2019
First Posted Date  ICMJE August 19, 2019
Last Update Posted Date December 24, 2020
Actual Study Start Date  ICMJE April 4, 2019
Estimated Primary Completion Date September 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 14, 2019)
  • Sit-to-stand time [ Time Frame: Preoperative (varies) and postoperative appointments (2 months after surgery) ]
    Change in sit-to-stand capabilities
  • Quadriceps Strength [ Time Frame: Preoperative and postoperative appointments (2 months after surgery) ]
    Change in quadriceps strength in lbs of force, as measured by PT dynamometer
  • 2 minute walking time [ Time Frame: Preoperative and postoperative appointments (2 months after surgery) ]
    Change in distance walked in 2 minutes
  • walking speed [ Time Frame: Preoperative and postoperative appointments (2 months after surgery) ]
    Change in walking speed
  • Balancing [ Time Frame: Preoperative and postoperative appointments (2 months after surgery) ]
    Change in proprioception (balance) as measured by 30-second single limb stance PT test
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 16, 2019)
  • Visual analogue scale (VAS) pain [ Time Frame: first postoperative months (from days post-op through 2-month post-operative appointment) ]
    Change in Visual Analog Scale for pain (1-10) 1 no pain 10 worse
  • Visual analogue scale (VAS) nausea [ Time Frame: first postoperative months (from days post-op through 2-month post-operative appointment) ]
    Change in VAS nausea (Visual Analog Scale for nausea (1-10) 1 no nausea 10 worse nausea )
  • Visual analogue scale (VAS) satisfaction [ Time Frame: first postoperative months (from days post-op through 2-month post-operative appointment) ]
    Change in VAS satisfaction (Visual Analog Scale for satisfaction (1-10) 1 not satisfied, 10 totally unsatisfied)
  • Readmission rate [ Time Frame: Noted by PI at 2nd postoperative appointment (about 10 weeks after surgery) ]
    major complication
  • Infection rate [ Time Frame: Noted by PI at 2nd postoperative appointment (about 10 weeks after surgery) ]
    superficial and deep infection
  • Cost per treatment regimen (iGetBetter vs. CyMedica E-vive vs. home PT) [ Time Frame: Completion of study (anticipate one year from start data 4/4/2019) ]
    We will calculate the total cost of each treatment modality
Original Secondary Outcome Measures  ICMJE
 (submitted: August 14, 2019)
  • Visual analogue scale (VAS) pain [ Time Frame: first postoperative months (from days post-op through 2-month post-operative appointment) ]
    Change in VAS pain
  • Visual analogue scale (VAS) nausea [ Time Frame: first postoperative months (from days post-op through 2-month post-operative appointment) ]
    Change in VAS pain
  • Visual analogue scale (VAS) satisfaction [ Time Frame: first postoperative months (from days post-op through 2-month post-operative appointment) ]
    Change in VAS satisfaction
  • Readmission rate [ Time Frame: Noted by PI at 2nd postoperative appointment (about 10 weeks after surgery) ]
    major complication
  • Infection rate [ Time Frame: Noted by PI at 2nd postoperative appointment (about 10 weeks after surgery) ]
    superficial and deep infection
  • Cost per treatment regimen (iGetBetter vs. CyMedica E-vive vs. home PT) [ Time Frame: Completion of study (anticipate one year from start data 4/4/2019) ]
    We will calculate the total cost of each treatment modality
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Is There an Alternative to Immediate Home Physical Therapy Following Total Knee Arthroplasty
Official Title  ICMJE Is There an Alternative to Immediate Home Physical Therapy Following Total Knee Arthroplasty
Brief Summary The purpose of this study is to evaluate how different pre-operative therapeutic approaches affect quad strength and patient satisfaction after total knee replacements. There are three treatments groups: standard physical therapy protocol, the use of CyMedica NMES garments, and a telemedical home therapy program.
Detailed Description Patients undergoing total knee replacement (TKR) at Brigham and Women's Faulkner Hospital and meet all eligibility criteria will be informed about the study and asked if they would like to participate. The research assistant (RA) will screen upcoming surgeries and call all qualifying patients to inform them of the study. Those who show interest will be offered the opportunity to discuss with both the RA and Principal Investigator (PI). Upon agreement, the patient's consent will be obtained and they will be randomly assigned to one of three treatment groups using a computer-generated randomization.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Participants assigned to one of three groups, there is no crossover. Participants remain in their assigned group until completion of study.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Total Knee Arthroplasty
Intervention  ICMJE
  • Device: CyMedica e-vive™ System; CY-1000

    All the patients in Group 2 will be given the CyMedica Orthopedics e-vive system 3 weeks before the surgery. The patients will begin using the unit after their first pre-intervention measurements are taken.

    Patients will be instructed to apply the e-vive NMES Strength therapy twice a day, 5 days a week. The NMES Strength program is 20 minutes in length. Treatment intensity (adjustable from 1 to 100 in NMES programs) is required to be set at the highest tolerable limit for the patients.

    Stimulation from the garment will have the following parameters: frequency of 50 Hz; pulse duration of 5 ms; time on: 12.8 seconds; and time off: 10 seconds. The total contraction time in a 20-minute treatment will be 11 minutes. The waveform will be pulsed and asymmetrical.

    Other Name: Powered Muscle Stimulator or Neuromuscular Electrical Stimulator (NMES); IPF Transcutaneous Nerve Stimulator (TENS) for pain relief; GZJ Goniometer; KQX
  • Other: iGetBetter telemedicine physical therapy
    Group 1 patients will only use a Post-Op program from iGetBetter for the first 3 weeks after surgery. After those 3 weeks have elapsed, Group 1 patients will receive outpatient physical therapy in addition to iGetBetter, approximately twice per week for the next 6-8 weeks as all other groups.
Study Arms  ICMJE
  • Experimental: Group 1, iGetBetter Group
    Use only iGetBetter for the 3 months preceding surgery. After surgery, you will be given a new, Post-Op program to use for 2-3 months. For the first 3 weeks, you will only use iGetBetter. After those 3 weeks, you will receive outpatient physical therapy in addition to iGetBetter, approximately twice per week for the next 6-8 weeks.
    Intervention: Other: iGetBetter telemedicine physical therapy
  • Experimental: Group 2, E-vive Group
    You will use iGetBetter starting 3 months out from surgery. You will receive CyMedica's electrical-stimulation garment during the preoperative appointment. In addition to iGetBetter, you will wear the conductive garment two times each day for the last 3 weeks before surgery. After surgery, for the first 3 weeks you will only use the conductive garment, and will not use iGetBetter. After those 3 weeks, you will receive outpatient physical therapy in addition to wearing the brace, approximately twice per week for the next 6-8 weeks. You will not need to return the brace after this time is up, and you may keep the brace, if you so choose, at no cost.
    Intervention: Device: CyMedica e-vive™ System; CY-1000
  • No Intervention: Group 3, Physical Therapy Group
    You will receive only iGetBetter for the 3 months preceding surgery. After surgery, you will receive only home physical therapy, and will not use iGetBetter. After those three weeks, you will receive outpatient physical therapy approximately twice per week for the next 6-8 weeks.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: August 14, 2019)
87
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date September 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 18 or older
  • Owns a device with internet connection
  • Can download the E-vive application for the contractile garment (has sufficiently up-to-date phone or tablet, or has family member with such a device).
  • Has a rudimentary understanding of Internet technology, especially e-mail
  • Has a flexion of 90 o and flexion contracture of 5 o at the point of discharge
  • Approved by a physical therapist to participate safely in the study at the time of discharge

Exclusion Criteria:

  • Rheumatoid arthritis
  • History of epilepsy
  • Implanted and body-worn electronic medical device, including cardiac pacemakers, neural stimulators, insulin pumps, etc.
  • Poor understanding of the use of the brace/electrical stimulation
  • Lesions on the skin over the thigh
  • Uncontrolled diabetes
  • Uncontrolled hypertension
  • Bilateral TKA or UKA planned
  • If female, pregnant
  • Cannot use non-operated leg postoperatively to propel active motion splint, caused by neurological or muscular diseases such as complete or incomplete paralysis or other causes of weakness with an inability to bend or extend knee
  • Loss of sensation in operated or non-operated leg
  • Has below- or above-knee amputations of non-operative leg
  • Below- knee amputation of operated side
  • Chronic pain syndrome with inability to walk
  • Taking chronic narcotics and/or is taking more than 10mg codeine per day, or any Hydrocodone, or more than 200 mg of tramadol, or any other narcotics prescribed for moderate to severe pain
  • Involved in pain clinics for chronic pain, or pain that is not related to the knee
  • Has been diagnosed with knee disorder other than osteoarthritis, post-traumatic osteoarthritis, gout, pseudo gout, or any inability to walk due to disorders unrelated to the knee (e.g., hip disorders, spinal stenosis, paralysis, hemi-paralysis)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04060251
Other Study ID Numbers  ICMJE 2018P000932
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: No IPD will be shared with other researchers.
Responsible Party Wolfgang Fitz, M.D., Brigham and Women's Hospital
Study Sponsor  ICMJE Wolfgang Fitz, M.D.
Collaborators  ICMJE CyMedica Orthopedics, Inc
Investigators  ICMJE
Principal Investigator: Wolfgang Fitz, MD Brigham and Women's Hospital
PRS Account Brigham and Women's Hospital
Verification Date December 2020

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