Virtual vs. Traditional Physical Therapy Following Total Knee Replacement

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Total Knee Replacement

Clinical Trial Details

NCT number	NCT02914210
Study type	Interventional
Source	Duke University
Contact
Status	Completed
Phase	N/A
Start date	October 2016
Completion date	March 2018

View Details

See also
Status	Clinical Trial	Phase
Terminated	`NCT04040985` - Legion Primary Safety and Efficacy	N/A
Recruiting	`NCT05279092` - Yale Steroid Enhanced Versus Exparel Nerveblock TKA RCT Study	Phase 2
Completed	`NCT03286543` - Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System	N/A
Not yet recruiting	`NCT04594447` - Physica System KR vs Physica System CR (K-20)	N/A
Completed	`NCT02413996` - Effects of Virtual Reality Rehabilitation in Patients With Total Knee Arthroplasty	N/A
Completed	`NCT01500252` - Patellar Resurfacing Versus Patellar Retention in Total Knee Arthroplasty - A Randomized Clinical Trial	Phase 4
Recruiting	`NCT04081493` - The Efficacy of Low-load Blood Flow Restricted Resistance Before TKR	N/A
Active, not recruiting	`NCT03339557` - Comparison of Three Knee Replacements	N/A
Enrolling by invitation	`NCT04513145` - Adductor Canal Block	Phase 2/Phase 3
Recruiting	`NCT06045078` - Aromatherapy in Total Knee Replacement	N/A
Completed	`NCT02468934` - Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty (TKA) Using the SPRINT System	N/A
Withdrawn	`NCT01523418` - Study to Observe Safety of Xarelto in VTE Prophlylaxis After Elective TKR (Total Knee Replacement) or THR (Total Hip Replacement)	N/A
Completed	`NCT00795223` - Comparative Pain Control Between 0.2 or 0.3 Spinal Morphine and 0.25 or 0.5 % Bupivacaine for FNB After TKA	Phase 4
Completed	`NCT01307202` - Morphine Consumption in Joint Replacement Patients, With or Without Gabapentin Treatment	N/A
Completed	`NCT01515449` - Predictors of Poor Outcomes in 1038 Sigma Knees	N/A
Completed	`NCT01522781` - 10 Year Outcome of Total Knee Replacement (TKR) Using Sigma Prosthesis	N/A
Completed	`NCT04166539` - Neurotoxicity and Cardiotoxicity in Total Joint Arthroplasty
Completed	`NCT03454256` - Virtual Reality Rehabilitation in Patients With Total Knee Replacement	N/A
Enrolling by invitation	`NCT06118073` - Effect of Mindfulness on Pain After Total Knee Arthroplasty	N/A
Completed	`NCT05597046` - Qualitative Interviews With Healthcare Professionals

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.