The purpose of this study is to study the efficacy of a remote range of motion monitor, the Knee Glider, alongside a patient engagement platform, Force Therapeutics, on clinical improvements and cost following primary TKA.
The purpose of this study is to study the efficacy of a remote range of motion monitor, the Knee Glider, alongside a patient engagement platform, Force Therapeutics, on clinical improvements and cost following primary TKA. Patients will be given the opportunity to participate, and enrolled and consented participants will be treated and followed by physicians from OSI Orthopedic \& Sports Medicine. Upon consent, patients will be randomized to receive the active range of motion monitor (the knee glider) two weeks prior to surgery, near day of surgery to use postoperatively, or standard of care (no knee glider). All patients enrolled in the study will have access to Force Therapeutics, patient engagement and outcome collection system utilized by OSI Orthopedic \& Sports Medicine. Enrolled subjects will be followed from the time of consent, through 6 months following surgery. Patients who are randomized into groups receiving the knee glider will receive the knee glider for up to 4 weeks following surgery, and compliance will be monitored. The hypothesis of this study is that patients who utilize an active range of motion monitor (the knee glider) will have improved clinical outcomes over patients receiving standard of care.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
200
The purpose of this study is to study the efficacy of a remote range of motion monitor, the Knee Glider, alongside a patient engagement platform, Force Therapeutics, on clinical improvements and cost following primary TKA.
Baseline Patient Characteristics
Intended to collect patient demographics, contact information, birth date, surgery date, age and other baseline demographic variables.
Time frame: Baseline
Knee Injury and Osteoarthritis Outcome Score (KOOS Jr.)
Intended to elicit people's opinions about the difficulties they experience due to problems with their knee and covers aspects of pain, functional limitations and knee-related quality of life. KOOS, JR is scored by summing the raw response (range 0-28) and then converting it to an interval score using the table provided below. The interval score ranges from 0 to 100 where 0 represents total knee disability and 100 represents perfect knee health.
Time frame: Baseline, 2 Weeks Post Op, 6 Weeks Post Op, 12 Weeks Post Op, 6 Months Post Op,
Knee Injury and Osteoarthritis Outcome Score (KOOS Jr.)
Intended to elicit people's opinions about the difficulties they experience due to problems with their knee and covers aspects of pain, functional limitations and knee-related quality of life. KOOS, JR is scored by summing the raw response (range 0-28) and then converting it to an interval score using the table provided below. The interval score ranges from 0 to 100 where 0 represents total knee disability and 100 represents perfect knee health.
Time frame: 6 Weeks Post Op
Knee Injury and Osteoarthritis Outcome Score (KOOS Jr.)
Intended to elicit people's opinions about the difficulties they experience due to problems with their knee and covers aspects of pain, functional limitations and knee-related quality of life. KOOS, JR is scored by summing the raw response (range 0-28) and then converting it to an interval score using the table provided below. The interval score ranges from 0 to 100 where 0 represents total knee disability and 100 represents perfect knee health.
Time frame: 12 Weeks Post Op
Knee Injury and Osteoarthritis Outcome Score (KOOS Jr.)
Intended to elicit people's opinions about the difficulties they experience due to problems with their knee and covers aspects of pain, functional limitations and knee-related quality of life. KOOS, JR is scored by summing the raw response (range 0-28) and then converting it to an interval score using the table provided below. The interval score ranges from 0 to 100 where 0 represents total knee disability and 100 represents perfect knee health.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 6 Months Post Op
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
1. The WOMAC is a disease-specific tool used for people with hip or knee OA to measure physical function, pain, and stiffness in the past 48 hours. 2. The WOMAC is a self-administered instrument containing 24 items measuring 3 subscales: physical function (17 items), pain (5 items), and stiffness (2 items). 3. Scores can be calculated for each subscale and a total score is calculated by adding all 3 subscale scores. Higher points signify higher levels of functional difficulty.
Time frame: Baseline
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
1. The WOMAC is a disease-specific tool used for people with hip or knee OA to measure physical function, pain, and stiffness in the past 48 hours. 2. The WOMAC is a self-administered instrument containing 24 items measuring 3 subscales: physical function (17 items), pain (5 items), and stiffness (2 items). 3. Scores can be calculated for each subscale and a total score is calculated by adding all 3 subscale scores. Higher points signify higher levels of functional difficulty.
Time frame: 6 Weeks Post Op
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
1. The WOMAC is a disease-specific tool used for people with hip or knee OA to measure physical function, pain, and stiffness in the past 48 hours. 2. The WOMAC is a self-administered instrument containing 24 items measuring 3 subscales: physical function (17 items), pain (5 items), and stiffness (2 items). 3. Scores can be calculated for each subscale and a total score is calculated by adding all 3 subscale scores. Higher points signify higher levels of functional difficulty.
Time frame: 12 Weeks Post Op
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
1. The WOMAC is a disease-specific tool used for people with hip or knee OA to measure physical function, pain, and stiffness in the past 48 hours. 2. The WOMAC is a self-administered instrument containing 24 items measuring 3 subscales: physical function (17 items), pain (5 items), and stiffness (2 items). 3. Scores can be calculated for each subscale and a total score is calculated by adding all 3 subscale scores. Higher points signify higher levels of functional difficulty.
Time frame: 6 Months Post Op
Veterans RAND 12 (VR-12)
a. The Veterans RAND 12 Item Health Survey (VR-12) is a patient-reported global health measure that is used to assess a patient's overall perspective of their health.
Time frame: Baseline
Veterans RAND 12 (VR-12)
The Veterans RAND 12 Item Health Survey (VR-12) is a patient-reported global health measure that is used to assess a patient's overall perspective of their health.
Time frame: 6 Weeks Post Op
Veterans RAND 12 (VR-12)
The Veterans RAND 12 Item Health Survey (VR-12) is a patient-reported global health measure that is used to assess a patient's overall perspective of their health.
Time frame: 12 Weeks Post Op
Veterans RAND 12 (VR-12)
The Veterans RAND 12 Item Health Survey (VR-12) is a patient-reported global health measure that is used to assess a patient's overall perspective of their health.
Time frame: 6 Months Post Op
Force Patient Engagement
Engagement on the patient engagement platform including logins, exercise videos watched and patient recorded outcome measures (PROM) compliance during platform access
Time frame: Baseline
Force Patient Engagement
Engagement on the patient engagement platform including logins, exercise videos watched and patient recorded outcome measures (PROM) compliance during platform access
Time frame: 2 Weeks Post Op
Force Patient Engagement
Engagement on the patient engagement platform including logins, exercise videos watched and patient recorded outcome measures (PROM) compliance during platform access
Time frame: 6 Weeks Post Op
Force Patient Engagement
Engagement on the patient engagement platform including logins, exercise videos watched and patient recorded outcome measures (PROM) compliance during platform access
Time frame: 12 Weeks Post Op
Force Patient Engagement
Engagement on the patient engagement platform including logins, exercise videos watched and patient recorded outcome measures (PROM) compliance during platform access
Time frame: 6 Months Post Op
Range of Motion via the Knee Glider
Daily Knee Flexion and Extension for the duration of utilizing the knee glider
Time frame: Baseline
Range of Motion via the Knee Glider
Daily Knee Flexion and Extension for the duration of utilizing the knee glider
Time frame: 2 Weeks Post Op
Range of Motion via the Knee Glider
Daily Knee Flexion and Extension for the duration of utilizing the knee glider
Time frame: 6 Weeks Post Op
Range of Motion via the Knee Glider
Daily Knee Flexion and Extension for the duration of utilizing the knee glider
Time frame: 12 Weeks Post Op
Range of Motion (Exam / Patient Reported)
a. Knee Flexion and Extension via in clinic exam or patient reported via the Force Therapeutics Platform
Time frame: Baseline
Range of Motion (Exam / Patient Reported)
a. Knee Flexion and Extension via in clinic exam or patient reported via the Force Therapeutics Platform (0 to 110 degrees)
Time frame: 2 Weeks Post Op
Range of Motion (Exam / Patient Reported)
a. Knee Flexion and Extension via in clinic exam or patient reported via the Force Therapeutics Platform (0 to 110 degrees)
Time frame: 6 Weeks Post Op
Range of Motion (Exam / Patient Reported)
a. Knee Flexion and Extension via in clinic exam or patient reported via the Force Therapeutics Platform (0 to 110 degrees)
Time frame: 12 Weeks Post Op
Daily NRS Pain (Continuous)
The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain
Time frame: Baseline
Daily NRS Pain (Continuous)
The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain
Time frame: 2 Weeks
Daily NRS Pain (Continuous)
The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain
Time frame: 6 Weeks
Daily NRS Pain (Continuous)
The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain
Time frame: 12 Weeks
Discharge Services Utilization & Cost
The Discharge Services Utilization \& Cost survey is intended collect patient discharge information. The survey consists of 16 questions asking about where they went for physical therapy, how much it costs, and if any adverse events resulted in admission to an Emergency Room or Urgent Care.
Time frame: 6 Weeks Post Op
Discharge Services Utilization & Cost
The Discharge Services Utilization \& Cost survey is intended collect patient discharge information. The survey consists of 16 questions asking about where they went for physical therapy, how much it costs, and if any adverse events resulted in admission to an Emergency Room or Urgent Care.
Time frame: 12 Weeks Post Op
Knee Glider Satisfaction
The Knee Glider Satisfaction questionnaire is a 4 question survey asking about patient experience using the glider.
Time frame: 2 Weeks Post Op
Knee Glider Satisfaction
The Knee Glider Satisfaction questionnaire is a 4 question survey asking about patient experience using the glider.
Time frame: 6 Weeks Post Op
Knee Glider Satisfaction
The Knee Glider Satisfaction questionnaire is a 4 question survey asking about patient experience using the glider.
Time frame: 12 Weeks Post Op
Total Joint Replacement (TJR) Satisfaction
The TJR Satisfaction survey intends to understand patient experience and satisfaction results with their total joint replacement procedure.
Time frame: 12 Weeks Post Op
Total Joint Replacement (TJR) Satisfaction
The TJR Satisfaction survey intends to understand patient experience and satisfaction results with their total joint replacement procedure.
Time frame: 6 Months Post Op