Total Knee Arthroplasty (TKA)NCT05310474
Does an Active Range of Motion Monitor Improve Outcomes/Decrease Cost for Patients Undergoing Total Knee Arthroplasty?
A study testing Knee Glider in people with Total Knee Arthroplasty (TKA), run by Force Therapeutics.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Knee Arthroplasty (TKA)
- What is being tested?
- Knee Glider
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 30 Apr 2022to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Individuals who have undergone Total Knee Arthroplasty (TKA) and have agreed to participate in this study.
Who cannot join
- Individuals who have not undergone TKA.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Does an Active Range of Motion Monitor Improve Outcomes and Decrease Cost for Patients Undergoing Total Knee Arthroplasty?
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.
Read the detailed description
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.
- Conditions
- Total Knee Arthroplasty (TKA)
- Being tested
- Knee Glider
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Knee GliderDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Group C | No intervention | Upon 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 | Experimental | Upon 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. Receives: Device: Knee Glider |
| Group A | Experimental | Upon 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. Receives: Device: Knee Glider |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline Patient Characteristics
Intended to collect patient demographics, contact information, birth date, surgery date, age and other baseline demographic variables.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 Months Post Op
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
- 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.
- The WOMAC is a self-administered instrument containing 24 items measuring 3 subscales: physical function (17 items), pain (5 items), and stiffness (2 items).
- 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.
Measured: Baseline
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
- 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.
- The WOMAC is a self-administered instrument containing 24 items measuring 3 subscales: physical function (17 items), pain (5 items), and stiffness (2 items).
- 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.
Measured: 6 Weeks Post Op
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
- 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.
- The WOMAC is a self-administered instrument containing 24 items measuring 3 subscales: physical function (17 items), pain (5 items), and stiffness (2 items).
- 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.
Measured: 12 Weeks Post Op
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
- 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.
- The WOMAC is a self-administered instrument containing 24 items measuring 3 subscales: physical function (17 items), pain (5 items), and stiffness (2 items).
- 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.
Measured: 6 Months 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 6 Months Post Op
Range of Motion via the Knee Glider
Daily Knee Flexion and Extension for the duration of utilizing the knee glider
Measured: Baseline
Range of Motion via the Knee Glider
Daily Knee Flexion and Extension for the duration of utilizing the knee glider
Measured: 2 Weeks Post Op
Range of Motion via the Knee Glider
Daily Knee Flexion and Extension for the duration of utilizing the knee glider
Measured: 6 Weeks Post Op
Range of Motion via the Knee Glider
Daily Knee Flexion and Extension for the duration of utilizing the knee glider
Measured: 12 Weeks Post Op
Range of Motion (Exam / Patient Reported)
- Knee Flexion and Extension via in clinic exam or patient reported via the Force Therapeutics Platform
Measured: Baseline
Range of Motion (Exam / Patient Reported)
- Knee Flexion and Extension via in clinic exam or patient reported via the Force Therapeutics Platform (0 to 110 degrees)
Measured: 2 Weeks Post Op
Range of Motion (Exam / Patient Reported)
- Knee Flexion and Extension via in clinic exam or patient reported via the Force Therapeutics Platform (0 to 110 degrees)
Measured: 6 Weeks Post Op
Range of Motion (Exam / Patient Reported)
- Knee Flexion and Extension via in clinic exam or patient reported via the Force Therapeutics Platform (0 to 110 degrees)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 12 Weeks Post Op
Knee Glider Satisfaction
The Knee Glider Satisfaction questionnaire is a 4 question survey asking about patient experience using the glider.
Measured: 2 Weeks Post Op
Knee Glider Satisfaction
The Knee Glider Satisfaction questionnaire is a 4 question survey asking about patient experience using the glider.
Measured: 6 Weeks Post Op
Knee Glider Satisfaction
The Knee Glider Satisfaction questionnaire is a 4 question survey asking about patient experience using the glider.
Measured: 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.
Measured: 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.
Measured: 6 Months Post Op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start30 Apr 2022 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee Arthroplasty (TKA)Studies of the same condition, open and under way.
- 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
- Model description
- This study includes 3 arms.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Force Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- OSI Orthopedics and Sports Medicine, Rehab 360 Knee Glider
- Responsible party
- Sponsor
- Investigators
- Alan Cornett, DO, Principal investigator, OSI Orthopedic Sports Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05310474
- Sponsor's protocol ID
- Rehab360 Knee Glider
- Status last verified
- Apr 2022
- First submitted
- 14 Dec 2021
- Last updated
- 14 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does an Active Range of Motion Monitor Improve Outcomes and Decrease Cost for Patients Undergoing Total Knee Arthroplasty?
- ClinicalTrials.gov ID
- NCT05310474
- Acronym / sponsor ID
- Rehab360 Knee Glider
- Conditions
- Total Knee Arthroplasty (TKA)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Force TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- OSI Orthopedics and Sports Medicine, Rehab 360 Knee Glider
- Study start
- 30 Apr 2022 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 5 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- This study includes 3 arms.
| Arm | Type | Receives |
|---|---|---|
| Group C | No intervention | –Upon 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 | Experimental | Device: Knee GliderUpon 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 | Experimental | Device: Knee GliderUpon 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Individuals who have undergone Total Knee Arthroplasty (TKA) and have agreed to participate in this study.
Key exclusion criteria (1 listed)
- Individuals who have not undergone TKA.
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 |
|---|---|---|
| Knee GliderThe 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. | Device | Group A, Group B |
Primary outcome
Baseline Patient Characteristics
Time frame: Baseline
Intended to collect patient demographics, contact information, birth date, surgery date, age and other baseline demographic variables.
Knee Injury and Osteoarthritis Outcome Score (KOOS Jr.)
Time frame: Baseline, 2 Weeks Post Op, 6 Weeks Post Op, 12 Weeks Post Op, 6 Months Post Op,
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.
Knee Injury and Osteoarthritis Outcome Score (KOOS Jr.)
Time frame: 6 Weeks Post Op
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.
Knee Injury and Osteoarthritis Outcome Score (KOOS Jr.)
Time frame: 12 Weeks Post Op
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.
Knee Injury and Osteoarthritis Outcome Score (KOOS Jr.)
Time frame: 6 Months Post Op
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.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: Baseline
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.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: 6 Weeks Post Op
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.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: 12 Weeks Post Op
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.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: 6 Months Post Op
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.
Veterans RAND 12 (VR-12)
Time frame: Baseline
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.
Veterans RAND 12 (VR-12)
Time frame: 6 Weeks Post Op
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.
Veterans RAND 12 (VR-12)
Time frame: 12 Weeks Post Op
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.
Veterans RAND 12 (VR-12)
Time frame: 6 Months Post Op
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.
Force Patient Engagement
Time frame: Baseline
Engagement on the patient engagement platform including logins, exercise videos watched and patient recorded outcome measures (PROM) compliance during platform access
Force Patient Engagement
Time frame: 2 Weeks Post Op
Engagement on the patient engagement platform including logins, exercise videos watched and patient recorded outcome measures (PROM) compliance during platform access
Force Patient Engagement
Time frame: 6 Weeks Post Op
Engagement on the patient engagement platform including logins, exercise videos watched and patient recorded outcome measures (PROM) compliance during platform access
Force Patient Engagement
Time frame: 12 Weeks Post Op
Engagement on the patient engagement platform including logins, exercise videos watched and patient recorded outcome measures (PROM) compliance during platform access
Force Patient Engagement
Time frame: 6 Months Post Op
Engagement on the patient engagement platform including logins, exercise videos watched and patient recorded outcome measures (PROM) compliance during platform access
Range of Motion via the Knee Glider
Time frame: Baseline
Daily Knee Flexion and Extension for the duration of utilizing the knee glider
Range of Motion via the Knee Glider
Time frame: 2 Weeks Post Op
Daily Knee Flexion and Extension for the duration of utilizing the knee glider
Range of Motion via the Knee Glider
Time frame: 6 Weeks Post Op
Daily Knee Flexion and Extension for the duration of utilizing the knee glider
Range of Motion via the Knee Glider
Time frame: 12 Weeks Post Op
Daily Knee Flexion and Extension for the duration of utilizing the knee glider
Range of Motion (Exam / Patient Reported)
Time frame: Baseline
a. Knee Flexion and Extension via in clinic exam or patient reported via the Force Therapeutics Platform
Range of Motion (Exam / Patient Reported)
Time frame: 2 Weeks Post Op
a. Knee Flexion and Extension via in clinic exam or patient reported via the Force Therapeutics Platform (0 to 110 degrees)
Range of Motion (Exam / Patient Reported)
Time frame: 6 Weeks Post Op
a. Knee Flexion and Extension via in clinic exam or patient reported via the Force Therapeutics Platform (0 to 110 degrees)
Range of Motion (Exam / Patient Reported)
Time frame: 12 Weeks Post Op
a. Knee Flexion and Extension via in clinic exam or patient reported via the Force Therapeutics Platform (0 to 110 degrees)
Daily NRS Pain (Continuous)
Time frame: Baseline
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
Daily NRS Pain (Continuous)
Time frame: 2 Weeks
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
Daily NRS Pain (Continuous)
Time frame: 6 Weeks
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
Daily NRS Pain (Continuous)
Time frame: 12 Weeks
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
Discharge Services Utilization & Cost
Time frame: 6 Weeks Post Op
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.
Discharge Services Utilization & Cost
Time frame: 12 Weeks Post Op
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.
Knee Glider Satisfaction
Time frame: 2 Weeks Post Op
The Knee Glider Satisfaction questionnaire is a 4 question survey asking about patient experience using the glider.
Knee Glider Satisfaction
Time frame: 6 Weeks Post Op
The Knee Glider Satisfaction questionnaire is a 4 question survey asking about patient experience using the glider.
Knee Glider Satisfaction
Time frame: 12 Weeks Post Op
The Knee Glider Satisfaction questionnaire is a 4 question survey asking about patient experience using the glider.
Total Joint Replacement (TJR) Satisfaction
Time frame: 12 Weeks Post Op
The TJR Satisfaction survey intends to understand patient experience and satisfaction results with their total joint replacement procedure.
Total Joint Replacement (TJR) Satisfaction
Time frame: 6 Months Post Op
The TJR Satisfaction survey intends to understand patient experience and satisfaction results with their total joint replacement procedure.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2022.
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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.
Alan Cornett, DO principal investigator
OSI Orthopedic Sports Medicine
Questions about this trial
What is this clinical trial studying?
A study testing Knee Glider in people with Total Knee Arthroplasty (TKA), run by Force Therapeutics.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 14 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joyce Harary, BA (6463319165, joyce@forcetherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline Patient Characteristics (time frame: Baseline). The study lists 37 primary outcomes in all. 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 14 Apr 2022.