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

Total Knee Arthroplasty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04060251
• Other study ID #: 2018P000932
• Status: Terminated
• Phase: N/A
• Start date: April 4, 2019
• Est. completion date: January 17, 2022

Study information

• Verified date: May 2023
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: January 17, 2022
• Est. primary completion date: January 17, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Total Knee Arthroplasty

Intervention

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

Other:
• iGetBetter telemedicine physical therapy
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.

Locations

Country	Name	City	State
United States	Brigham and Women's Faulkner Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Wolfgang Fitz, M.D.	CyMedica Orthopedics, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sit-to-stand Time	Change in sit-to-stand capabilities	Preoperative (varies) and postoperative appointments (2 months after surgery)
Primary	Quadriceps Strength	Change in quadriceps strength in lbs of force, as measured by PT dynamometer	Preoperative and postoperative appointments (2 months after surgery)
Primary	2 Minute Walking Time	Change in distance walked in 2 minutes	Preoperative and postoperative appointments (2 months after surgery)
Primary	Walking Speed	Change in walking speed	Preoperative and postoperative appointments (2 months after surgery)
Primary	Balancing	Change in proprioception (balance) as measured by 30-second single limb stance PT test	Preoperative and postoperative appointments (2 months after surgery)
Secondary	Visual Analogue Scale (VAS) Pain	Change in Visual Analog Scale for pain (1-10) 1 no pain 10 worse	first postoperative months (from days post-op through 2-month post-operative appointment)
Secondary	Visual Analogue Scale (VAS) Nausea	Change in VAS nausea (Visual Analog Scale for nausea (1-10) 1 no nausea 10 worse nausea )	first postoperative months (from days post-op through 2-month post-operative appointment)
Secondary	Visual Analogue Scale (VAS) Satisfaction	Change in VAS satisfaction (Visual Analog Scale for satisfaction (1-10) 1 not satisfied, 10 totally unsatisfied)	first postoperative months (from days post-op through 2-month post-operative appointment)
Secondary	Readmission Rate	major complication	Noted by PI at 2nd postoperative appointment (about 10 weeks after surgery)
Secondary	Infection Rate	superficial and deep infection	Noted by PI at 2nd postoperative appointment (about 10 weeks after surgery)
Secondary	Cost Per Treatment Regimen (iGetBetter vs. CyMedica E-vive vs. Home PT)	We will calculate the total cost of each treatment modality	Completion of study (anticipate one year from start data 4/4/2019)