Clinical trial NCT05310474: Does an Active Range of Motion Monitor Improve Outcomes/Decrease Cost for Patients Undergoing Total Knee Arthroplasty?
Official title: Does an Active Range of Motion Monitor Improve Outcomes and Decrease Cost for Patients Undergoing Total Knee Arthroplasty?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Total Knee Arthroplasty (TKA)
Lead sponsor: Force Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: OSI Orthopedics and Sports Medicine
name: Rehab 360 Knee Glider
First posted: 2022-04-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study includes 3 arms.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Baseline Patient Characteristics
timeFrame: Baseline
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS Jr.)
timeFrame: Baseline, 2 Weeks Post Op, 6 Weeks Post Op, 12 Weeks Post Op, 6 Months Post Op,
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS Jr.)
timeFrame: 6 Weeks Post Op
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS Jr.)
timeFrame: 12 Weeks Post Op
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS Jr.)
timeFrame: 6 Months Post Op
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: Baseline
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: 6 Weeks Post Op
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: 12 Weeks Post Op
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: 6 Months Post Op
measure: Veterans RAND 12 (VR-12)
timeFrame: Baseline
measure: Veterans RAND 12 (VR-12)
timeFrame: 6 Weeks Post Op
measure: Veterans RAND 12 (VR-12)
timeFrame: 12 Weeks Post Op
measure: Veterans RAND 12 (VR-12)
timeFrame: 6 Months Post Op
measure: Force Patient Engagement
timeFrame: Baseline
measure: Force Patient Engagement
timeFrame: 2 Weeks Post Op
measure: Force Patient Engagement
timeFrame: 6 Weeks Post Op
measure: Force Patient Engagement
timeFrame: 12 Weeks Post Op
measure: Force Patient Engagement
timeFrame: 6 Months Post Op
measure: Range of Motion via the Knee Glider
timeFrame: Baseline
measure: Range of Motion via the Knee Glider
timeFrame: 2 Weeks Post Op
measure: Range of Motion via the Knee Glider
timeFrame: 6 Weeks Post Op
measure: Range of Motion via the Knee Glider
timeFrame: 12 Weeks Post Op
measure: Range of Motion (Exam / Patient Reported)
timeFrame: Baseline
measure: Range of Motion (Exam / Patient Reported)
timeFrame: 2 Weeks Post Op
measure: Range of Motion (Exam / Patient Reported)
timeFrame: 6 Weeks Post Op
measure: Range of Motion (Exam / Patient Reported)
timeFrame: 12 Weeks Post Op
measure: Daily NRS Pain (Continuous)
timeFrame: Baseline
measure: Daily NRS Pain (Continuous)
timeFrame: 2 Weeks
measure: Daily NRS Pain (Continuous)
timeFrame: 6 Weeks
measure: Daily NRS Pain (Continuous)
timeFrame: 12 Weeks
measure: Discharge Services Utilization & Cost
timeFrame: 6 Weeks Post Op
measure: Discharge Services Utilization & Cost
timeFrame: 12 Weeks Post Op
measure: Knee Glider Satisfaction
timeFrame: 2 Weeks Post Op
measure: Knee Glider Satisfaction
timeFrame: 6 Weeks Post Op
measure: Knee Glider Satisfaction
timeFrame: 12 Weeks Post Op
measure: Total Joint Replacement (TJR) Satisfaction
timeFrame: 12 Weeks Post Op
measure: Total Joint Replacement (TJR) Satisfaction
timeFrame: 6 Months Post Op
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: OSI Orthopedic Sports Medicine
name: Alan Cornett, DO
role: PRINCIPAL_INVESTIGATOR
References: