Status:
TERMINATED
Is There an Alternative to Immediate Home Physical Therapy Following Total Knee Arthroplasty
Lead Sponsor:
Wolfgang Fitz, M.D.
Collaborating Sponsors:
CyMedica Orthopedics, Inc
Conditions:
Total Knee Arthroplasty
Eligibility:
All Genders
18+ years
Phase:
NA
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 grou...
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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
April 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 17 2022
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT04060251
Start Date
April 4 2019
End Date
January 17 2022
Last Update
June 7 2023
Active Locations (1)
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1
Brigham and Women's Faulkner Hospital
Boston, Massachusetts, United States, 02130