Does an Active Range of Motion Monitor Improve Outcomes/Decrease Cost for Patients Undergoing Total Knee Arthroplasty?
1 other identifier
interventional
200
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2022
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 14, 2021
CompletedFirst Posted
Study publicly available on registry
April 5, 2022
CompletedStudy Start
First participant enrolled
April 30, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedApril 14, 2022
April 1, 2022
8 months
December 14, 2021
April 6, 2022
Conditions
Outcome Measures
Primary Outcomes (37)
Baseline Patient Characteristics
Intended to collect patient demographics, contact information, birth date, surgery date, age and other baseline demographic variables.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
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
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
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
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
6 Months Post Op
Range of Motion via the Knee Glider
Daily Knee Flexion and Extension for the duration of utilizing the knee glider
Baseline
Range of Motion via the Knee Glider
Daily Knee Flexion and Extension for the duration of utilizing the knee glider
2 Weeks Post Op
Range of Motion via the Knee Glider
Daily Knee Flexion and Extension for the duration of utilizing the knee glider
6 Weeks Post Op
Range of Motion via the Knee Glider
Daily Knee Flexion and Extension for the duration of utilizing the knee glider
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
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)
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)
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)
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
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
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
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
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.
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.
12 Weeks Post Op
Knee Glider Satisfaction
The Knee Glider Satisfaction questionnaire is a 4 question survey asking about patient experience using the glider.
2 Weeks Post Op
Knee Glider Satisfaction
The Knee Glider Satisfaction questionnaire is a 4 question survey asking about patient experience using the glider.
6 Weeks Post Op
Knee Glider Satisfaction
The Knee Glider Satisfaction questionnaire is a 4 question survey asking about patient experience using the glider.
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.
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.
6 Months Post Op
Study Arms (3)
Group C
NO INTERVENTIONUpon consent, patients will be randomized to receive standard of care, and not be given the active range of motion monitor (the knee glider) two weeks prior to surgery. All patients enrolled in the study will have access to Force Therapeutics, patient engagement and outcome collection system utilized by OSI Orthopedic \& Sports Medicine.
Group B
EXPERIMENTALUpon consent, patients will be randomized to receive the active range of motion monitor (the knee glider) close to surgery to use postoperatively (through week 4). All patients enrolled in the study will have access to Force Therapeutics, patient engagement and outcome collection system utilized by OSI Orthopedic \& Sports Medicine.
Group A
EXPERIMENTALUpon consent, patients will be randomized to receive the active range of motion monitor (the knee glider) Receives Knee Glider 2 weeks prior to surgery to utilize through postoperative week 4. All patients enrolled in the study will have access to Force Therapeutics, patient engagement and outcome collection system utilized by OSI Orthopedic \& Sports Medicine.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Individuals who have undergone Total Knee Arthroplasty (TKA) and have agreed to participate in this study.
You may not qualify if:
- Individuals who have not undergone TKA.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Force Therapeuticslead
- OSI Orthopedics and Sports Medicinecollaborator
- Rehab 360 Knee Glidercollaborator
Study Officials
- PRINCIPAL INVESTIGATOR
Alan Cornett, DO
OSI Orthopedic Sports Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 14, 2021
First Posted
April 5, 2022
Study Start
April 30, 2022
Primary Completion
December 31, 2022
Study Completion
December 31, 2023
Last Updated
April 14, 2022
Record last verified: 2022-04