Clinical trial NCT04060251: Is There an Alternative to Immediate Home Physical Therapy Following Total Knee Arthroplasty
Official title: Is There an Alternative to Immediate Home Physical Therapy Following Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Total Knee Arthroplasty
Keywords: Total knee arthroplasty
Physical therapy
Neuromuscular electrical stimulation
Telemedicine
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: CyMedica Orthopedics, Inc
First posted: 2019-08-19
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants assigned to one of three groups, there is no crossover. Participants remain in their assigned group until completion of study.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Sit-to-stand Time
timeFrame: Preoperative (varies) and postoperative appointments (2 months after surgery)
measure: Quadriceps Strength
timeFrame: Preoperative and postoperative appointments (2 months after surgery)
measure: 2 Minute Walking Time
timeFrame: Preoperative and postoperative appointments (2 months after surgery)
measure: Walking Speed
timeFrame: Preoperative and postoperative appointments (2 months after surgery)
measure: Balancing
timeFrame: Preoperative and postoperative appointments (2 months after surgery)
Secondary outcomes:
measure: Visual Analogue Scale (VAS) Pain
timeFrame: first postoperative months (from days post-op through 2-month post-operative appointment)
measure: Visual Analogue Scale (VAS) Nausea
timeFrame: first postoperative months (from days post-op through 2-month post-operative appointment)
measure: Visual Analogue Scale (VAS) Satisfaction
timeFrame: first postoperative months (from days post-op through 2-month post-operative appointment)
measure: Readmission Rate
timeFrame: Noted by PI at 2nd postoperative appointment (about 10 weeks after surgery)
measure: Infection Rate
timeFrame: Noted by PI at 2nd postoperative appointment (about 10 weeks after surgery)
measure: Cost Per Treatment Regimen (iGetBetter vs. CyMedica E-vive vs. Home PT)
timeFrame: Completion of study (anticipate one year from start data 4/4/2019)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Faulkner Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Wolfgang Fitz, MD
role: PRINCIPAL_INVESTIGATOR
References: