← Back to Search

2. Intervention group: Medial off-loader brace with OPUM Digital Knee and Remote Patient Monitoring for Osteoarthritis

N/A

Waitlist Available

Led By Prakash Jayabalan, MD, PhD

Research Sponsored by OPUM Technologies US LTD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a special knee brace with a tracking device for people with knee osteoarthritis. The device monitors knee movements and activities, sending data to a mobile phone for real-time monitoring. This aims to reduce pain and improve quality of life by making exercise programs more effective and convenient. Braces designed to unload the more diseased part of the knee have been used to provide relief from osteoarthritis.

Eligible Conditions

Osteoarthritis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pain subscore on the Knee injury and Osteoarthritis Score (KOOS Survey)

Secondary study objectives

5 times sit-to-stand

Condition Improvement

Digital Knee Data (for intervention group)

+11 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: 2. Intervention group: Medial off-loader brace with OPUM Digital Knee and Remote Patient MonitoringExperimental Treatment1 Intervention

The same off-loader brace as above but with the ODK sensor will be provided. The subject will be instructed how to wear the brace and sensor. The patient will be instructed to incrementally increase wear time in the first week to get accustomed to the brace to reach a minimum of 6 hours per day after the first week. Using the sensor they will be able to keep track of their exercise frequency, range of motion (ROM), and kinematics in the OPUM app on their mobile phone. Education/resources will also be provided to the subjects via modules in the mobile app. The subjects will be instructed how to use the app as well. Patients data will be monitored remotely for 20mins per patient per month in the sensor group. Programs will be updated as necessary based on data.

Group II: Control group: Medial off-loader brace and home exercise programActive Control1 Intervention

The subject will receive a traditional medial off-loader brace and a take-home, self-guided exercise program. The subject will be instructed how to wear the brace. The subject will be instructed to incrementally increase wear time of the brace in the first week to get accustomed to the brace to reach a minimum of 6 hours per day after the first week.

Do I qualify?Apply below to find out