Limited Market Release - MotionSense Clinical Use Evaluation

NCT ID: NCT05091918

Last Updated: 2024-07-10

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-27

Study Completion Date

2022-08-01

Brief Summary

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Prospective evaluation of patient compliance and prescribed home exercise program using MotionSense wearable system during recovery from primary total knee arthroplasty.

Detailed Description

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During the proposed study, the MotionSense wearable system will be used by patients undergoing total knee arthroplasty (TKA) surgery leading up to and after their surgery. The patients will be using the system to monitor their recovery during daily activities, log daily pain scores and patient reported outcomes while also supporting their prescribed home exercise program. Each patient will thereby participate in outpatient physiotherapy in line with their current standard of care, while the physiotherapist will leverage the opportunities of the presented platform to give the patient personalized reminders for their patient-specific home exercise program. The surgeon / research nurse will additionally be able to monitor the patients recovery remotely as the sensor / app data is shared to the OrthoLogIQ platform.

Conditions

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Knee Arthroplasty Patient Engagement Patient-Reported Outcome Measures (PROMs)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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MotionSense Wearable

Using MotionSense from pre-op to 90 days post-op during the recovery after primary TKA

Group Type OTHER

MotionSense

Intervention Type DEVICE

MotionSense Wearable: Remote patient monitoring

Interventions

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MotionSense

MotionSense Wearable: Remote patient monitoring

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Planned for unilateral total knee surgery in the coming 4 weeks
* Age 50 to 80
* Owns a smart phone

Exclusion Criteria

* BMI exceeding 35
* Severe skin conditions
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Orthosensor, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Oklahoma Joint Reconstruction Institute

Oklahoma City, Oklahoma, United States

Site Status

Robotic Joint Replacement Institute LLC

Wakefield, Rhode Island, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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Orthosensor

Identifier Type: -

Identifier Source: org_study_id

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