Does an Active Range of Motion Monitor Improve Outcomes/Decrease Cost for Patients Undergoing Total Knee Arthroplasty?

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Total Knee Arthroplasty (TKA)
• Intervention / Treatment: Device: Knee Glider

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 Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joyce Harary, BA; Phone Number: 6463319165; Email: joyce@forcetherapeutics.com
• Study Contact Backup: Name: Ben Koerner, DO, MBA; Phone Number: (316)648-5158; Email: benkoerner5@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Individuals who have undergone Total Knee Arthroplasty (TKA) and have agreed to participate in this study.

Exclusion Criteria:

• Individuals who have not undergone TKA.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Group C; 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.
EXPERIMENTAL: Group B; 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.	Device: Knee Glider; 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.
EXPERIMENTAL: Group A; 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.	Device: Knee Glider; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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.	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.	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.	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.	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

Collaborators and Investigators

• Sponsor: Force Therapeutics
• Collaborators: OSI Orthopedics and Sports Medicine; Rehab 360 Knee Glider
• Investigators: Principal Investigator: Alan Cornett, DO, OSI Orthopedic Sports Medicine

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): April 30, 2022
• Primary Completion (ANTICIPATED): December 31, 2022
• Study Completion (ANTICIPATED): December 31, 2023

Study Registration Dates

• First Submitted: December 14, 2021
• First Submitted That Met QC Criteria: March 25, 2022
• First Posted (ACTUAL): April 5, 2022

Study Record Updates

• Last Update Posted (ACTUAL): April 14, 2022
• Last Update Submitted That Met QC Criteria: April 6, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: Rehab360 Knee Glider

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No