Brief Summary

The aim of this exploratory study is to further investigate the potential of acoustic emission biomarkers, assessed by the inmodi knee brace, to diagnose osteoarthritis (OA) at earlier stages. Therefore, 20 healthy participants and 100 patients with increased risk of knee OA will be recruited from the Schulthess Klinik in Zurich and examined twice with 9 ± 3 months' time interval. Anthropometric data, EOS radiographs and MR images of both knees, PROMs and acoustic emission data will be collected and evaluated. Artificial Intelligence algorithm will then be used to identify and validate the most promising acoustic emission biomarkers with a prognosis value in the prediction of knee osteoarthritis progress.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

120

participants targeted

Target at P50-P75 for all trials

Timeline

Completed

Started Jan 2023

Geographic Reach

1 country

1 active site

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

2 years study duration

Study Start

First participant enrolled

January 1, 2023

Completed

10 months until next milestone

First Submitted

Initial submission to the registry

October 25, 2023

Completed

6 months until next milestone

First Posted

Study publicly available on registry

April 8, 2024

Completed

4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed

Last Updated

April 19, 2024

Status Verified

April 1, 2024

Enrollment Period

1.6 years

First QC Date

October 25, 2023

Last Update Submit

April 17, 2024

Conditions

Osteoarthritis, Knee Diagnosis

Keywords

Acoustic emissionKnee Osteoarthritis

Outcome Measures

Primary Outcomes (5)

acoustic emissions
Acoustic sensors are embedded in the hardware of the inmodi knee brace, allowing the non-invasively collection of acoustic data at frequencies between 100Hz and 20 kHz. During data analysis, signals will be segmented and frequency components of low interest will be removed. Specific sound features, such as spectral, fractality, peak amplitude or click patters will be extracted. Data of both knees will be assessed at the same time with the inmodi knee brace (v2) during four different tests, based on recommendations by the Osteoarthritis Research Society International (OARSI) for people with knee OA: - unloaded flexion-extension (F/E) of the knee in a seated position, - Sit-to-Stand test (STS), - One-step test (OST), - Walk test. Associations between the extracted sound parameters and kinematic data, MOAKS grading, KL grading, leg alignment angles and PROMS will be studied to identify biomarkers with a prognosis value in the prediction of OA progress.
1 year and 2 years
kinematic data
Inertial sensors, also embedded in the hardware, do collect movement trajectories at the same time during the four different tests. This kinematic data will be combined with the acoustic emissions to analyze which sound features appear at specific ranges of motion (knee flexion/extension).
1 year and 2 years
MRI / MOAKS
Patients will be scanned using a 3T MRI scanner (Magnetom Prisma, Siemens). MRI allow to visualize and assess structural changes in joint tissues, such as cartilage, meniscus and subchondral bone. Semi-quantitative scoring of these degenerative structures in OA will be done using the MRI Osteoarthritis Knee Score (MOAKS) system by a radiologist.
1 year and 2 years
EOS / leg alignment
Bilateral long-leg radiographic images will be acquired in a standing position as stereoradiography using the EOS Edge (EOS X-Ray Imaging Acquisition System, Paris, France). Images will be analyzed for OA grading (Kellgren-Lawrence grade 0 - 4) and leg alignment parameters (hip-knee-ankle angle, mechanical axis length and deviation, proximal tibia width and compartmental joint space width).
1 year and 2 years
PROMS
Five different patient reported outcome measures are used: * Oxford Knee Score: contains 12 questions about individual's activities of daily living and how they have been affected by pain over the last 4 weeks. * Core Outcome Measures Index Knee: assesses the main outcomes of importance to patients with knee problems (pain, function, symptom-specific well-being, quality of life, disability). * University of California at Los Angeles: an activity rating scale, which rates the activity level of joint replacement patients globally in one out of 10. * Knee injury and osteoarthritis outcome score: an instrument to assess the patient's opinion about their knee and associated problems. * Forgotten Joint Score 12 is a concise 12-item PROM that evaluates patients' ability to forget their joint in daily life.
1 year and 2 years

Study Arms (6)

A: healthy participants

20 healthy participants judging themselves to be of good subjective health without any knee problems