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

Wolfgang Fitz, M.D.

Status: Terminated

Conditions: Total Knee Arthroplasty

Treatments: Other: iGetBetter telemedicine physical therapy; Device: CyMedica e-vive™ System; CY-1000

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04060251

2018P000932

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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21 participants in 3 patient groups

Group 1, iGetBetter Group

Experimental group

Description:

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.

Treatment:

Other: iGetBetter telemedicine physical therapy

Group 2, E-vive Group

Experimental group

Description:

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.

Treatment:

Device: CyMedica e-vive™ System; CY-1000

Group 3, Physical Therapy Group

No Intervention group

Description:

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.