Total Knee Replacement
Conditions
Keywords
TKR, TKA, Knee, Surgery, Replacement, Rehabilitation, Virtual, Physical Therapy, Telerehabilitation
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.
Interventions
DEVICEVirtual physical therapy rehabilitation program
Virtual Exercise Rehabilitation Assistant (VERA), a virtual physical therapy delivery system installed in patient's home
OTHERNo intervention
Traditional physical therapy delivered in clinic or via home-health visits
Sponsors
Reflexion Health, Inc.
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Range of Motion | 6 weeks | Knee range of motion \[lower (extension) and upper range of motion (flexion)\] at 6 weeks |
| 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. |
| 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-domain Scores | 6 weeks and 12 weeks | Scores in KOOS sub-domains of pain, symptoms, activities of daily living (ADL), sports and recreation, and quality of life (QOL). Each sub-domain score can be normalized to values ranging from 0 to 100. Higher scores denote better outcomes. |
| Physical Activity | 6 weeks and 12 weeks | Physical activity (duration of moderate exercise in total minutes per week) |
| Return to Work | 6 weeks and 12 weeks | Return to work (yes, modified schedule, or no) for those who stopped working prior to surgery |
| Patient-Reported Outcomes Measurement Information System (PROMIS) - Mental Health (MH) Score | 12 weeks | PROMIS mental health score at 12 weeks, on a scale of 0 to 20 with higher scores indicating better mental health. |
| Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Health (PH) Score | 12 weeks | PROMIS physical health score at 12 weeks, on a scale of 0 to 20, with higher scores indicating better physical health. |
| Satisfaction With Physical Function | 12 weeks | Score on Satisfaction with Physical Function questionnaire through 12 weeks after surgery, on a scale of 0 to 6, with 6 being higher satisfaction. |
| Satisfaction With Tele-rehab Platform | 12 weeks | Satisfaction with tele-rehab platform, on scale of 0 to 10, with 10 being highly satisfied. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Virtual Physical Therapy Virtual physical therapy rehabilitation program (VERA) used in the home with care planning and remote support and monitoring by physical therapists
Virtual physical therapy rehabilitation program: Virtual Exercise Rehabilitation Assistant (VERA), a virtual physical therapy delivery system installed in patient's home | 151 |
| Traditional Physical Therapy No intervention. Standard home health physical therapy and/or outpatient clinic physical therapy as prescribed.
No intervention: Traditional physical therapy delivered in clinic or via home-health visits | 153 |
| Total | 304 |
Baseline characteristics
| Characteristic | Virtual Physical Therapy | Traditional Physical Therapy | Total |
|---|---|---|---|
| Age, Continuous | 65.4 years STANDARD_DEVIATION 7.7 | 65.1 years STANDARD_DEVIATION 9.2 | 65.2 years STANDARD_DEVIATION 8.5 |
| Race/Ethnicity, Customized Hispanic or Latino Ethnicity No or Not Reported | 147 Participants | 153 Participants | 300 Participants |
| Race/Ethnicity, Customized Hispanic or Latino Ethnicity Yes | 4 Participants | 0 Participants | 4 Participants |
| Race/Ethnicity, Customized Race Black | 16 Participants | 28 Participants | 44 Participants |
| Race/Ethnicity, Customized Race Missing | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Multiple | 4 Participants | 3 Participants | 7 Participants |
| Race/Ethnicity, Customized Race Other | 2 Participants | 3 Participants | 5 Participants |
| Race/Ethnicity, Customized Race White | 128 Participants | 119 Participants | 247 Participants |
| RAPT Score | 10.1 units on a scale STANDARD_DEVIATION 1.3 | 9.7 units on a scale STANDARD_DEVIATION 1.6 | 9.9 units on a scale STANDARD_DEVIATION 1.4 |
| Region of Enrollment United States | 151 participants | 153 participants | 304 participants |
| Sex: Female, Male Female | 90 Participants | 100 Participants | 190 Participants |
| Sex: Female, Male Male | 61 Participants | 53 Participants | 114 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 143 | 0 / 144 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
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.
Time frame: 12 weeks
Population: Patients randomized and receiving eligible surgery, and completing the study through 12 weeks post surgery.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Virtual Physical Therapy | Cost Difference in US Dollars | 1050.00 US Dollars |
| Traditional Physical Therapy | Cost Difference in US Dollars | 2805.00 US Dollars |
Secondary
10-meter Gait Speed
Gait speed 6 weeks after surgery
Time frame: 6 weeks
Population: Patients randomized and receiving eligible surgery, completing study through 12 weeks, and having gait speed measured.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Physical Therapy | 10-meter Gait Speed | 1.0 minutes | Standard Deviation 0.3 |
| Traditional Physical Therapy | 10-meter Gait Speed | 1.0 minutes | Standard Deviation 0.3 |
Secondary
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.
Time frame: 6 weeks and 12 weeks
Population: Patients randomized and receiving eligible surgery, completing study through 12 weeks, and providing complete responses to survey questions
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Virtual Physical Therapy | Knee Injury and Osteoarthritis Outcome Score (KOOS) | 6 weeks | 61.0 score on a scale | Standard Deviation 11.5 |
| Virtual Physical Therapy | Knee Injury and Osteoarthritis Outcome Score (KOOS) | 12 weeks | 69.6 score on a scale | Standard Deviation 12.1 |
| Traditional Physical Therapy | Knee Injury and Osteoarthritis Outcome Score (KOOS) | 6 weeks | 61.8 score on a scale | Standard Deviation 13.5 |
| Traditional Physical Therapy | Knee Injury and Osteoarthritis Outcome Score (KOOS) | 12 weeks | 67.2 score on a scale | Standard Deviation 14.3 |
Secondary
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.
Time frame: 12 weeks
Population: Patients randomized and receiving eligible surgery, completing study through 12 weeks, and responding to survey question regarding pain.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Physical Therapy | Pain Score | 2.7 score on a scale | Standard Deviation 2 |
| Traditional Physical Therapy | Pain Score | 3.0 score on a scale | Standard Deviation 2.6 |
Secondary
Range of Motion
Knee range of motion \[lower (extension) and upper range of motion (flexion)\] at 6 weeks
Time frame: 6 weeks
Population: Patients randomized and receiving eligible surgery, completing study through 12 weeks, and having range of motion measured at specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Virtual Physical Therapy | Range of Motion | Knee Extension (straight leg) | 2.5 degrees from parallel to floor | Standard Deviation 3.6 |
| Virtual Physical Therapy | Range of Motion | Knee Flexion (bent leg) | 114.5 degrees from parallel to floor | Standard Deviation 15.3 |
| Traditional Physical Therapy | Range of Motion | Knee Extension (straight leg) | 2.9 degrees from parallel to floor | Standard Deviation 3.4 |
| Traditional Physical Therapy | Range of Motion | Knee Flexion (bent leg) | 111.4 degrees from parallel to floor | Standard Deviation 16 |
Secondary
Re-hospitalization
Re-hospitalizations since hospital discharge (total count)
Time frame: 12 weeks
Population: Patients randomized and receiving eligible surgery, completing study through 12 weeks, and providing complete responses to survey questions.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Physical Therapy | Re-hospitalization | 0.1 number of rehospitalizations per patient | Standard Deviation 0.3 |
| Traditional Physical Therapy | Re-hospitalization | 0.2 number of rehospitalizations per patient | Standard Deviation 0.5 |
Secondary
Report of Falls
Any fall reported between hospital discharge and 12-week follow-up (yes/no)
Time frame: 12 weeks
Population: Patients randomized and receiving eligible surgery, completing study through 12 weeks, and answering survey question regarding falls.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Virtual Physical Therapy | Report of Falls | 19.4 percentage of patients |
| Traditional Physical Therapy | Report of Falls | 14.6 percentage of patients |
Other Pre-specified
Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-domain Scores
Scores in KOOS sub-domains of pain, symptoms, activities of daily living (ADL), sports and recreation, and quality of life (QOL). Each sub-domain score can be normalized to values ranging from 0 to 100. Higher scores denote better outcomes.
Time frame: 6 weeks and 12 weeks
Population: Patients randomized and receiving eligible surgery, completing study through 12 weeks, and providing complete responses to survey questions.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Virtual Physical Therapy | Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-domain Scores | Pain (12 weeks) | 78.4 score on a scale | Standard Deviation 14 |
| Virtual Physical Therapy | Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-domain Scores | Pain (6 weeks) | 66.6 score on a scale | Standard Deviation 15.6 |
| Virtual Physical Therapy | Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-domain Scores | Symptoms (6 weeks) | 54.7 score on a scale | Standard Deviation 11.5 |
| Virtual Physical Therapy | Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-domain Scores | Function/Daily Living (6 weeks) | 76.4 score on a scale | Standard Deviation 13.9 |
| Virtual Physical Therapy | Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-domain Scores | Sports/Recreation (6 weeks) | 51.2 score on a scale | Standard Deviation 29.4 |
| Virtual Physical Therapy | Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-domain Scores | Quality of Life (6 weeks) | 46.5 score on a scale | Standard Deviation 18.7 |
| Virtual Physical Therapy | Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-domain Scores | Symptoms (12 weeks) | 54.9 score on a scale | Standard Deviation 12.2 |
| Virtual Physical Therapy | Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-domain Scores | Function/Daily Living (12 weeks) | 82.7 score on a scale | Standard Deviation 13.6 |
| Virtual Physical Therapy | Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-domain Scores | Sports/Recreation (12 weeks) | 75.6 score on a scale | Standard Deviation 109.2 |
| Virtual Physical Therapy | Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-domain Scores | Quality of Life (12 weeks) | 61.8 score on a scale | Standard Deviation 18.8 |
| Traditional Physical Therapy | Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-domain Scores | Function/Daily Living (12 weeks) | 80.9 score on a scale | Standard Deviation 17.7 |
| Traditional Physical Therapy | Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-domain Scores | Pain (12 weeks) | 76.7 score on a scale | Standard Deviation 17.5 |
| Traditional Physical Therapy | Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-domain Scores | Quality of Life (6 weeks) | 50.5 score on a scale | Standard Deviation 19.6 |
| Traditional Physical Therapy | Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-domain Scores | Pain (6 weeks) | 68.7 score on a scale | Standard Deviation 17.1 |
| Traditional Physical Therapy | Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-domain Scores | Quality of Life (12 weeks) | 58.3 score on a scale | Standard Deviation 20 |
| Traditional Physical Therapy | Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-domain Scores | Symptoms (6 weeks) | 53.9 score on a scale | Standard Deviation 11.8 |
| Traditional Physical Therapy | Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-domain Scores | Symptoms (12 weeks) | 53.9 score on a scale | Standard Deviation 11.1 |
| Traditional Physical Therapy | Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-domain Scores | Function/Daily Living (6 weeks) | 75.7 score on a scale | Standard Deviation 16.6 |
| Traditional Physical Therapy | Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-domain Scores | Sports/Recreation (12 weeks) | 61.5 score on a scale | Standard Deviation 28.3 |
| Traditional Physical Therapy | Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-domain Scores | Sports/Recreation (6 weeks) | 50.2 score on a scale | Standard Deviation 31 |
Other Pre-specified
Patient-Reported Outcomes Measurement Information System (PROMIS) - Mental Health (MH) Score
PROMIS mental health score at 12 weeks, on a scale of 0 to 20 with higher scores indicating better mental health.
Time frame: 12 weeks
Population: Patients randomized and receiving eligible surgery, completing study through 12 weeks, and providing complete responses to survey questions.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Physical Therapy | Patient-Reported Outcomes Measurement Information System (PROMIS) - Mental Health (MH) Score | 16.6 score on a scale | Standard Deviation 2.5 |
| Traditional Physical Therapy | Patient-Reported Outcomes Measurement Information System (PROMIS) - Mental Health (MH) Score | 16.1 score on a scale | Standard Deviation 3.2 |
Other Pre-specified
Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Health (PH) Score
PROMIS physical health score at 12 weeks, on a scale of 0 to 20, with higher scores indicating better physical health.
Time frame: 12 weeks
Population: Patients randomized and receiving eligible surgery, completing study through 12 weeks, and providing complete responses to survey questions.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Physical Therapy | Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Health (PH) Score | 15.3 score on a scale | Standard Deviation 2.4 |
| Traditional Physical Therapy | Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Health (PH) Score | 14.8 score on a scale | Standard Deviation 2.8 |
Other Pre-specified
Physical Activity
Physical activity (duration of moderate exercise in total minutes per week)
Time frame: 6 weeks and 12 weeks
Population: Patients randomized and receiving eligible surgery, completing study through 12 weeks, and providing complete responses to survey questions.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Virtual Physical Therapy | Physical Activity | 12 weeks | 60 minutes per week |
| Virtual Physical Therapy | Physical Activity | 6 weeks | 40 minutes per week |
| Traditional Physical Therapy | Physical Activity | 6 weeks | 4 minutes per week |
| Traditional Physical Therapy | Physical Activity | 12 weeks | 60 minutes per week |
Other Pre-specified
Return to Work
Return to work (yes, modified schedule, or no) for those who stopped working prior to surgery
Time frame: 6 weeks and 12 weeks
Population: Patients randomized and receiving eligible surgery, completing study through 12 weeks, and providing complete responses to survey questions.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Virtual Physical Therapy | Return to Work | 6 weeks | No | 36 Participants |
| Virtual Physical Therapy | Return to Work | 12 weeks | Yes | 41 Participants |
| Virtual Physical Therapy | Return to Work | 6 weeks | Modified Schedule | 17 Participants |
| Virtual Physical Therapy | Return to Work | 12 weeks | Modified Schedule | 9 Participants |
| Virtual Physical Therapy | Return to Work | 12 weeks | No | 13 Participants |
| Virtual Physical Therapy | Return to Work | 6 weeks | Not recorded | 0 Participants |
| Virtual Physical Therapy | Return to Work | 12 weeks | Not recorded | 5 Participants |
| Virtual Physical Therapy | Return to Work | 6 weeks | Yes | 15 Participants |
| Traditional Physical Therapy | Return to Work | 12 weeks | Not recorded | 0 Participants |
| Traditional Physical Therapy | Return to Work | 6 weeks | Yes | 14 Participants |
| Traditional Physical Therapy | Return to Work | 6 weeks | Modified Schedule | 18 Participants |
| Traditional Physical Therapy | Return to Work | 6 weeks | No | 32 Participants |
| Traditional Physical Therapy | Return to Work | 6 weeks | Not recorded | 1 Participants |
| Traditional Physical Therapy | Return to Work | 12 weeks | Yes | 42 Participants |
| Traditional Physical Therapy | Return to Work | 12 weeks | Modified Schedule | 12 Participants |
| Traditional Physical Therapy | Return to Work | 12 weeks | No | 11 Participants |
Other Pre-specified
Satisfaction With Physical Function
Score on Satisfaction with Physical Function questionnaire through 12 weeks after surgery, on a scale of 0 to 6, with 6 being higher satisfaction.
Time frame: 12 weeks
Population: Patients randomized and receiving eligible surgery, completing study through 12 weeks, and providing complete responses to survey questions.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Physical Therapy | Satisfaction With Physical Function | 4.9 score on a scale | Standard Deviation 1.3 |
| Traditional Physical Therapy | Satisfaction With Physical Function | 4.9 score on a scale | Standard Deviation 1.2 |
Other Pre-specified
Satisfaction With Tele-rehab Platform
Satisfaction with tele-rehab platform, on scale of 0 to 10, with 10 being highly satisfied.
Time frame: 12 weeks
Population: Patients randomized and receiving eligible surgery, completing study through 12 weeks, using the virtual platform at least once, and providing response to survey question.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Virtual Physical Therapy | Satisfaction With Tele-rehab Platform | Neutral (score 7-8) | 7.2 percentage of participants |
| Virtual Physical Therapy | Satisfaction With Tele-rehab Platform | Promoters (score 9-10) | 83.3 percentage of participants |
| Virtual Physical Therapy | Satisfaction With Tele-rehab Platform | Detractors (score 0-6) | 9.5 percentage of participants |