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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

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.

Condition or disease Intervention/treatment Phase
Total Knee Arthroplasty Device: CyMedica e-vive™ System; CY-1000 Other: iGetBetter telemedicine physical therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 87 participants
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
Official Title: Is There an Alternative to Immediate Home Physical Therapy Following Total Knee Arthroplasty
Actual Study Start Date : April 4, 2019
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.

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.
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

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.



Primary Outcome Measures :
  1. Sit-to-stand time [ Time Frame: Preoperative (varies) and postoperative appointments (2 months after surgery) ]
    Change in sit-to-stand capabilities

  2. 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

  3. 2 minute walking time [ Time Frame: Preoperative and postoperative appointments (2 months after surgery) ]
    Change in distance walked in 2 minutes

  4. walking speed [ Time Frame: Preoperative and postoperative appointments (2 months after surgery) ]
    Change in walking speed

  5. 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


Secondary Outcome Measures :
  1. 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

  2. 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 )

  3. 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)

  4. Readmission rate [ Time Frame: Noted by PI at 2nd postoperative appointment (about 10 weeks after surgery) ]
    major complication

  5. Infection rate [ Time Frame: Noted by PI at 2nd postoperative appointment (about 10 weeks after surgery) ]
    superficial and deep infection

  6. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

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): NCT04060251


Locations
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United States, Massachusetts
Brigham and Women's Faulkner Hospital
Boston, Massachusetts, United States, 02130
Sponsors and Collaborators
Wolfgang Fitz, M.D.
CyMedica Orthopedics, Inc
Investigators
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Principal Investigator: Wolfgang Fitz, MD Brigham and Women's Hospital
  Study Documents (Full-Text)

Documents provided by Wolfgang Fitz, M.D., Brigham and Women's Hospital:
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Responsible Party: Wolfgang Fitz, M.D., Assistant Professor of Orthopedic Surgery, Harvard Medical School, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT04060251    
Other Study ID Numbers: 2018P000932
First Posted: August 19, 2019    Key Record Dates
Last Update Posted: December 24, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No IPD will be shared with other researchers.

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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
Keywords provided by Wolfgang Fitz, M.D., Brigham and Women's Hospital:
Total knee arthroplasty
Physical therapy
Neuromuscular electrical stimulation
Telemedicine