NCT05091918

Limited Market Release - MotionSense Clinical Use Evaluation

FS5 Limited Market Release - MotionSense Clinical Use Evaluation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Orthosensor, Inc. · Industry
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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

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

Interventions

Type	Name	Description
DEVICE	MotionSense	MotionSense Wearable: Remote patient monitoring

Timeline

• Start date: 2021-05-27
• Primary completion: 2022-08-01
• Completion: 2022-08-01
• First posted: 2021-10-25
• Last updated: 2024-07-10
• Results posted: 2023-09-07

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study