Virtual vs. Traditional Physical Therapy Following Total Knee Replacement



Status:Completed
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:18 - Any
Updated:5/27/2018
Start Date:October 2016
End Date:March 2018

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Virtual Exercise Rehabilitation In-home Therapy: A Randomized Study (VERITAS)

The goals of this research study are the following:

1. To compare the effects of tele-rehabilitation-supported physical therapy versus
traditional home and/or clinic-based physical therapy for total knee replacement (TKR)
on 90-day health service use costs.

2. To compare tele-rehabilitation-supported physical therapy and traditional physical
therapy on patient-centered outcomes

3. To explore whether individual patient characteristics are associated with differential
improvement from 6 to 12 weeks assessed by patient-reported outcomes.

This study will compare the effects on health service use costs of
tele-rehabilitation-supported physical therapy versus traditional home and/or clinic-based
physical therapy following total knee replacement (TKR) surgery. It will also examine
standard post-surgical clinical measures to confirm non-inferiority of outcomes between
groups. A total of 300 patients will receive standard pre- and post-surgical medical care
from their healthcare providers, and be randomized to receive pre-surgery rehabilitation
exercises ("pre-hab") and post-discharge physical therapy provided via either a home-based
tele-rehabilitation platform (intervention group, n=150) or home-health and clinic-based
physical therapy regimen (control group, n=150). Data will be collected by sites at
enrollment, baseline, hospital discharge, and 6 weeks following surgery. Patients will
complete telephone surveys regarding their health and knee function at baseline, 6 weeks, and
3 months after surgery. Patients will also keep a diary from hospital discharge through 3
months documenting healthcare utilization and progress toward a personal recovery goal. Diary
information will be collected over the phone concurrently with administration of the 6-week
and 3-month surveys. The episode for analysis will be from surgery through 3 months
post-discharge, in alignment with the Centers for Medicare and Medicaid Services
Comprehensive Care for Joint Replacement (CJR) bundled payment model. Physical risks or
benefits to patients for participating in this study are as expected from standard pre- and
post-surgical physical therapy associated with total knee replacement surgery. The low risk
of loss of confidentiality for all subjects will be minimized using appropriate safeguards.

Inclusion Criteria:

1. ≥ 18 years of age

2. Scheduled to have a non-traumatic TKR

3. Can be enrolled a minimum of 10 days prior to surgery (in-person visit)

4. Have a Risk Assessment and Prediction Tool (RAPT) score of ≥ 6 indicating expected
discharge home after surgical hospitalization

Exclusion Criteria:

1. Unable or unwilling to provide informed consent, including but not limited to
cognitive or language barriers (comprehension)

2. Scheduled for staged bilateral TKR

3. Living in a nursing home prior to surgery
We found this trial at
4
sites
101 Manning Drive
Chapel Hill, North Carolina 27514
Principal Investigator: Daniel Del Gaizo, MD
Phone: 919-966-5495
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Durham, North Carolina 27705
Principal Investigator: Thorsten Seyler, MD
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3200 Northline Avenue
Greensboro, North Carolina 27408
Principal Investigator: Frank Aluisio, MD
Phone: 336-404-1354
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Greensboro, NC
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Raleigh, North Carolina 27612
Principal Investigator: John Chiavetta, MD
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Raleigh, NC
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