Virtual vs. Traditional Physical Therapy Following Total Knee Replacement

Not Applicable

Completed

• Conditions: Total Knee Replacement
• Interventions: Device: Virtual physical therapy rehabilitation program; Other: No intervention

• Registration Number: NCT02914210
• Lead Sponsor: Duke University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2016-09-15
• Study First Submitted QC: 2016-09-22
• Study First Posted: 2016-09-26
• Study Start: 2016-10
• Primary Completion: 2018-03
• Study Completion: 2018-03
• Results First Submitted: 2019-12-13
• Results First Submitted QC: 2020-01-09
• Results First Posted: 2020-01-18
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-26
• Last Update Posted: 2021-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 306

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Virtual physical therapy	Virtual physical therapy rehabilitation program	Virtual physical therapy rehabilitation program (VERA) used in the home with care planning and remote support and monitoring by physical therapists
Traditional physical therapy	No intervention	No intervention. Standard home health physical therapy and/or outpatient clinic physical therapy as prescribed.

Primary Outcome Measures

Name	Time	Method
Cost Difference in US Dollars	12 weeks	Difference in total health service use costs at 12-weeks postoperative between patients who receive tele-rehab-supported PT versus traditional home and/or clinic-based PT for TKR.

Secondary Outcome Measures

Name	Time	Method
Range of Motion	6 weeks	Knee range of motion \[lower (extension) and upper range of motion (flexion)\] at 6 weeks
Knee Injury and Osteoarthritis Outcome Score (KOOS)	6 weeks and 12 weeks	Survey regarding health \[Knee Injury and Osteoarthritis Outcome Score (KOOS)\] for pain, symptoms, activities of daily living, function in sports and recreation, and knee-related quality of life (QOL) at 6 weeks and 12 weeks, scored from 0 to 100. Higher score indicates better outcomes.
Report of Falls	12 weeks	Any fall reported between hospital discharge and 12-week follow-up (yes/no)
Re-hospitalization	12 weeks	Re-hospitalizations since hospital discharge (total count)
10-meter Gait Speed	6 weeks	Gait speed 6 weeks after surgery
Pain Score	12 weeks	Non-inferiority safety endpoint: pain score at 12 weeks. Measured on scale from 0 to 10, with 0 being no pain and 10 being worst pain imaginable.

Trial Locations

Locations (4)

Greensboro Orthopedics; 🇺🇸 Greensboro, North Carolina, United States

Duke Orthopaedics; 🇺🇸 Durham, North Carolina, United States

University of North Carolina Orhthopedics; 🇺🇸 Chapel Hill, North Carolina, United States

Raleigh Orthopaedics; 🇺🇸 Raleigh, North Carolina, United States