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

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.

Study Overview

• Status: Terminated
• Conditions: Total Knee Arthroplasty
• Intervention / Treatment: Other: iGetBetter telemedicine physical therapy; Device: CyMedica e-vive™ System; CY-1000

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: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02130
      • Brigham and Women's Faulkner Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quadriceps Strength	Change in quadriceps strength in lbs of force, as measured by PT dynamometer	Preoperative and postoperative appointments (2 months after surgery)
Balancing	Change in proprioception (balance) as measured by 30-second single limb stance PT test	Preoperative and postoperative appointments (2 months after surgery)
Sit-to-stand Time	Change in sit-to-stand capabilities	Preoperative (varies) and postoperative appointments (2 months after surgery)
2 Minute Walking Time	Change in distance walked in 2 minutes	Preoperative and postoperative appointments (2 months after surgery)
Walking Speed	Change in walking speed	Preoperative and postoperative appointments (2 months after surgery)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale (VAS) Pain	Change in Visual Analog Scale for pain (1-10) 1 no pain 10 worse	first postoperative months (from days post-op through 2-month post-operative appointment)
Visual Analogue Scale (VAS) Nausea	Change in VAS nausea (Visual Analog Scale for nausea (1-10) 1 no nausea 10 worse nausea )	first postoperative months (from days post-op through 2-month post-operative appointment)
Visual Analogue Scale (VAS) Satisfaction	Change in VAS satisfaction (Visual Analog Scale for satisfaction (1-10) 1 not satisfied, 10 totally unsatisfied)	first postoperative months (from days post-op through 2-month post-operative appointment)
Readmission Rate	major complication	Noted by PI at 2nd postoperative appointment (about 10 weeks after surgery)
Infection Rate	superficial and deep infection	Noted by PI at 2nd postoperative appointment (about 10 weeks after surgery)
Cost Per Treatment Regimen (iGetBetter vs. CyMedica E-vive vs. Home PT)	We will calculate the total cost of each treatment modality	Completion of study (anticipate one year from start data 4/4/2019)

Collaborators and Investigators

• Sponsor: Wolfgang Fitz, M.D.
• Collaborators: CyMedica Orthopedics, Inc
• Investigators: Principal Investigator: Wolfgang Fitz, MD, Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2019
• Primary Completion (Actual): January 17, 2022
• Study Completion (Actual): January 17, 2022

Study Registration Dates

• First Submitted: April 3, 2019
• First Submitted That Met QC Criteria: August 14, 2019
• First Posted (Actual): August 19, 2019

Study Record Updates

• Last Update Posted (Actual): June 7, 2023
• Last Update Submitted That Met QC Criteria: May 11, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Telemedicine; Total knee arthroplasty; Physical therapy; Neuromuscular electrical stimulation
• Other Study ID Numbers: 2018P000932

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No IPD will be shared with other researchers.

Drug and device information, study documents

• 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