Total Knee ReplacementNCT02914210
Virtual vs. Traditional Physical Therapy Following Total Knee Replacement
A study testing Virtual physical therapy rehabilitation program in people with Total Knee Replacement, run by Duke University at 4 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Knee Replacement
- What is being tested?
- Virtual physical therapy rehabilitation program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 306 participants
- Where
- 4 sitesUnited States
- Study dates
- Oct 2016to Mar 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years of age
- Scheduled to have a non-traumatic TKR
- Can be enrolled a minimum of 10 days prior to surgery (in-person visit)
- Have a Risk Assessment and Prediction Tool (RAPT) score of ≥ 6 indicating expected discharge home after surgical hospitalization
Who cannot join
- Unable or unwilling to provide informed consent, including but not limited to cognitive or language barriers (comprehension)
- Scheduled for staged bilateral TKR
- Living in a nursing home prior to surgery
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of North Carolina Orhthopedics
Chapel Hill, North Carolina, 27514
Duke Orthopaedics
Durham, North Carolina, 27705
Greensboro Orthopedics
Greensboro, North Carolina, 27408
Raleigh Orthopaedics
Raleigh, North Carolina, 27612
About this study
Official title: Virtual Exercise Rehabilitation In-home Therapy: A Randomized Study (VERITAS)
The goals of this research study are the following:
- 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.
- To compare tele-rehabilitation-supported physical therapy and traditional physical therapy on patient-centered outcomes
- To explore whether individual patient characteristics are associated with differential improvement from 6 to 12 weeks assessed by patient-reported outcomes.
Read the 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.
- Conditions
- Total Knee Replacement
- Being tested
- Virtual physical therapy rehabilitation program, No intervention
- Keywords
- TKR, TKA, Knee, Surgery, Replacement, Rehabilitation, Virtual, Physical Therapy, Telerehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual physical therapy rehabilitation programDevice
Virtual Exercise Rehabilitation Assistant (VERA), a virtual physical therapy delivery system installed in patient's home
No interventionOther
Traditional physical therapy delivered in clinic or via home-health visits
| Study group | Role | What they receive |
|---|---|---|
| Virtual physical therapy | Other | Virtual physical therapy rehabilitation program (VERA) used in the home with care planning and remote support and monitoring by physical therapists Receives: Device: Virtual physical therapy rehabilitation program |
| Traditional physical therapy | Other | No intervention. Standard home health physical therapy and/or outpatient clinic physical therapy as prescribed. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost Difference in US Dollars
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.
Measured: 12 weeks
Secondary outcomes (6)
Knee Injury and Osteoarthritis Outcome Score (KOOS)
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.
Measured: 6 weeks and 12 weeks
Range of Motion
Knee range of motion [lower (extension) and upper range of motion (flexion)] at 6 weeks
Measured: 6 weeks
10-meter Gait Speed
Gait speed 6 weeks after surgery
Measured: 6 weeks
Pain Score
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.
Measured: 12 weeks
Report of Falls
Any fall reported between hospital discharge and 12-week follow-up (yes/no)
Measured: 12 weeks
Re-hospitalization
Re-hospitalizations since hospital discharge (total count)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2016 (estimated)
- Study startOct 2016
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Total Knee ReplacementStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 306 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Reflexion Health, Inc.
- Responsible party
- Sponsor
- Investigators
- Janet Bettger, ScD, Principal investigator, Duke Clinical Research Institute, Duke Dept of Orthopaedic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02914210
- Sponsor's protocol ID
- Pro00074409
- Status last verified
- Oct 2021
- First submitted
- 15 Sep 2016
- Last updated
- 2 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Exercise Rehabilitation In-home Therapy: A Randomized Study (VERITAS)
- ClinicalTrials.gov ID
- NCT02914210
- Acronym / sponsor ID
- Pro00074409
- Conditions
- Total Knee Replacement
- Keywords
- TKR, TKA, Knee, Surgery, Replacement, Rehabilitation, Virtual, Physical Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Reflexion Health, Inc.
- Study start
- Oct 2016 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 26 Sep 2016 (estimated)
- Results
- Posted 18 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goals of this research study are the following:
- 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.
- To compare tele-rehabilitation-supported physical therapy and traditional physical therapy on patient-centered outcomes
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual physical therapy | Other | Device: Virtual physical therapy rehabilitation programVirtual physical therapy rehabilitation program (VERA) used in the home with care planning and remote support and monitoring by physical therapists |
| Traditional physical therapy | Other | Other: No interventionNo intervention. Standard home health physical therapy and/or outpatient clinic physical therapy as prescribed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥ 18 years of age
- Scheduled to have a non-traumatic TKR
- Can be enrolled a minimum of 10 days prior to surgery (in-person visit)
- Have a Risk Assessment and Prediction Tool (RAPT) score of ≥ 6 indicating expected discharge home after surgical hospitalization
Key exclusion criteria (3 listed)
- Unable or unwilling to provide informed consent, including but not limited to cognitive or language barriers (comprehension)
- Scheduled for staged bilateral TKR
- Living in a nursing home prior to surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual physical therapy rehabilitation programVirtual Exercise Rehabilitation Assistant (VERA), a virtual physical therapy delivery system installed in patient's home | Device | Virtual physical therapy |
| No interventionTraditional physical therapy delivered in clinic or via home-health visits | Other | Traditional physical therapy |
Primary outcome
Cost Difference in US Dollars
Time frame: 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.
6 secondary outcomes
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 6 weeks and 12 weeks
Range of Motion
Time frame: 6 weeks
10-meter Gait Speed
Time frame: 6 weeks
Pain Score
Time frame: 12 weeks
Report of Falls
Time frame: 12 weeks
Re-hospitalization
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Total Knee Replacement
Recruiting
ACB and iPACK Blocks With Intravenous Dexamethasone and Perineural Dexmedetomidine in Total Knee Arthroplasty
Knee Osteoarthritis
Recruiting
SII Levels Following iPACK Block With Adductor Canal Block in Knee Arthroplasty
Knee Osteoarthritis
RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Symptomatic Venous Thromboembolism (VTE)
Enrolling by invitationObservational study
Persona SoluTion PPS Femur PMCF
Rhematoid Arthritis, Osteo Arthritis of the Knee
RecruitingObservational study
Preoperative Multimorbidity and Functional Recovery After Total Knee Arthroplasty
Knee Osteoarthritis, Multimorbidity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janet Bettger, ScD principal investigator
Duke Clinical Research Institute, Duke Dept of Orthopaedic Surgery
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual physical therapy rehabilitation program in people with Total Knee Replacement, run by Duke University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cost Difference in US Dollars (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2021.