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

Stopped early · Not applicable

Conditions studied: Total Knee Arthroplasty

In brief

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.

Key facts

Study ID

NCT04060251

Run by

Wolfgang Fitz, M.D.

People needed

21

Starts

2019-04-04

Expected to finish

2022-01-17

Last updated by the study team

2023-06-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

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
• 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)

Where it is running

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

Full record on ClinicalTrials.gov

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