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

NCT04060251 | Terminated Results FDA Device

• 1 other identifier: 2018P000932
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Knee Arthroplasty

Keywords

Total knee arthroplasty; Physical therapy; Neuromuscular electrical stimulation; Telemedicine

Outcome Measures

Primary Outcomes (5)

• Sit-to-stand Time

  Change in sit-to-stand capabilities

  Preoperative (varies) and postoperative appointments (2 months after surgery)

• Quadriceps Strength

  Change in quadriceps strength in lbs of force, as measured by PT dynamometer

  Preoperative 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)

• Balancing

  Change in proprioception (balance) as measured by 30-second single limb stance PT test

  Preoperative and postoperative appointments (2 months after surgery)

Secondary Outcomes (6)

• Visual Analogue Scale (VAS) Pain

  first postoperative months (from days post-op through 2-month post-operative appointment)

• Visual Analogue Scale (VAS) Nausea

  first postoperative months (from days post-op through 2-month post-operative appointment)

• Visual Analogue Scale (VAS) Satisfaction

  first postoperative months (from days post-op through 2-month post-operative appointment)

• Readmission Rate

  Noted by PI at 2nd postoperative appointment (about 10 weeks after surgery)

• Infection Rate

  Noted by PI at 2nd postoperative appointment (about 10 weeks after surgery)

Study Arms (3)

Group 1, iGetBetter Group

EXPERIMENTAL

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 2, E-vive Group

EXPERIMENTAL

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

Group 3, Physical Therapy Group

NO INTERVENTION

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.

Interventions

CyMedica e-vive™ System; CY-1000 DEVICE

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.

Also known as: Powered Muscle Stimulator or Neuromuscular Electrical Stimulator (NMES); IPF Transcutaneous Nerve Stimulator (TENS) for pain relief; GZJ Goniometer; KQX

Group 2, E-vive Group

iGetBetter telemedicine physical therapy OTHER

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.

Group 1, iGetBetter Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wolfgang Fitz, M.D.: lead
• CyMedica Orthopedics, Inc: collaborator

Study Sites (1)

Brigham and Women's Faulkner Hospital

Boston, Massachusetts, 02130, United States

Location

MeSH Terms

Interventions

Transcutaneous Electric Nerve Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Limitations and Caveats

Due to limitations caused by COVID, enrollment targets could not be met. Data was not collected for targets that were enrolled. No analysis of population was performed because no data was collected and therefore cannot be reported.

Results Point of Contact

• Title: Dr. Wolfgang Fitz
• Organization: Brigham Health

wfitz@bwh.harvard.edu

617-732-9501

Study Officials

• Wolfgang Fitz, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Orthopedic Surgery, Harvard Medical School

Model Details: Participants assigned to one of three groups, there is no crossover. Participants remain in their assigned group until completion of study.

Study Record Dates

• First Submitted: April 3, 2019
• First Posted: August 19, 2019
• Study Start: April 4, 2019
• Primary Completion: January 17, 2022
• Study Completion: January 17, 2022
• Last Updated: June 7, 2023
• Results First Posted: June 7, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)