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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-30

Study Completion Date

2023-12-31

Brief Summary

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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.

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Detailed Description

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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

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Total Knee Arthroplasty (TKA)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study includes 3 arms.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Knee Glider

Intervention Type DEVICE

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.

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.

Group Type EXPERIMENTAL

Knee Glider

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE