NCT05222503

Impact of Sensor Technology in Knee OA

Status unknown NA Last updated 3 February 2022

What this trial tests

NA trial testing Knee Brace + OPUM Digital Knee in Knee Osteoarthritis in 60 participants. Status unknown.

Timeline

19 August 2021

Primary endpoint
31 May 2022

14 July 2022

Quick facts

Lead sponsor	OPUM Technologies US LTD
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	60
Start date	19 August 2021
Primary completion	31 May 2022
Estimated completion	14 July 2022
Sites	1 location across United States

Drugs / interventions tested

• Knee Brace + OPUM Digital Knee
• Knee Brace

Conditions studied

• Knee Osteoarthritis — all drugs for Knee Osteoarthritis →

Sponsor

OPUM Technologies US LTD

Who can join

Adults 40 to 75, any sex, with Knee Osteoarthritis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

OBJECTIVES:

Physical activity has been established as an important component of rehabilitation for knee osteoarthritis (OA), and is often guided by a physical therapist.(1) Physical therapy for knee OA typically involves 1-3 sessions with a licensed physical therapist per week, for up to 12 weeks. These sessions can take a lot of time and effort for subjects, particularly when travel times are considered. Remote patient monitoring is an emerging treatment method which can help to reduce the need for in-person treatment sessions.

Remote patient monitoring has been tested in subjects after a total knee arthroplasty, and initial results show that subjects find the process motivating and engaging.(2) This process has not been tested in individuals with symptomatic knee OA. Prior studies have shown that personalized internet based programs are effective at improving function in individuals with knee OA(3), but the effectiveness of these programs with remote patient monitoring is unknown.

One example of current wearable technology that can be utilized for remote patient monitoring is the Opum (OPUM) Digital Knee® (ODK) modular orthotic. The ODK utilizes a wearable device in a knee brace which relays real time information back to the subject and physical therapist via their mobile phone. The ODK can provide information about sagittal and frontal plane knee kinematics, sagittal plane knee range of motion, time spent performing various daily activities, time spent exercising, overall load on the knee joint, and progress over time in each of these metrics. This device has been previously tested in subjects after an ACL reconstruction, but has yet to be tested in subjects with knee osteoarthritis.

The objective of this study is to assess the effect of the ODK technology in a medial knee unloader brace with remote patient monitoring on pain, function, and quality of life in individuals with knee OA. This study will contain two groups: A control group receiving a medial unloader brace and a personalized home exercise program, and an intervention group which will receive an ODK in a medial off-loader brace, and a home exercise program with remote patient monitoring.

The hypothesis is that subjects who wear the knee brace with the ODK with remote patient monitoring will have a greater reduction in pain and increase in quality of life than those who receive the brace with a home exercise program.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. State-of-the-Art and Next Generation Intra-Articular Implantable Biosensors for Osteoarthritis: From Analytical Limits to Operational Stability.
   Olayiwola AG, Abdossova A, Tosi D, Orive G, et al · · 2026 · PMID 42187479 · DOI 10.3390/bios16050283