Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
ID06490770

Analysis of the Pathophysiological and Functional State of the Knee Joint

Led by Istituto Ortopedico Rizzoli · Updated on 2025-07-17

25

Participants Needed

1

Research Sites

30 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Osteoarthritis is a common degenerative condition that affects the knee joint, causing pain and reduced function that worsens over time. It impacts both older and younger adults, sometimes due to injury. This research aims to better understand osteoarthritis onset and progression by improving diagnostic and prognostic methods, as current treatments mainly focus on managing symptoms rather than addressing underlying causes. The study evaluates the use of Magnetic Resonance Imaging (MRI) and gait analysis to examine the knee joint's condition and function. MRI will provide detailed images of joint tissues, while gait analysis, combined with sensor data and musculoskeletal models, will assess joint forces and movements during walking. These diagnostic tests will be conducted at the start of the study and again after 12 months to observe any changes. Participants will undergo MRI scans, strength tests using a manual dynamometer, bioimpedance analysis, gait analysis including electromyography, and complete clinical questionnaires at both baseline and 12-month follow-up visits. Researchers will monitor these assessments to understand joint health and function over time. The study does not involve any treatment but focuses on diagnostic evaluation, lasting at least one year for each participant.

CONDITIONS

Brief Title

Analysis of the Pathophysiological and Functional State of the Knee Joint

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Knee pain and/or loss of functionality
  • Kellgren-Lawrence grade less than or equal to 2
  • Arthroscopic evidence of cartilage tissue lesions
  • Evidence of cartilage and/or meniscal tissue degeneration and/or subchondral bone marrow lesions
  • Age between 18 and 60 years
Not Eligible

You will not qualify if you...

  • History or evidence of previous partial or total knee prosthesis interventions
  • Inability to provide informed consent
  • Conditions or physical disorders incompatible with the use of MRI and electrical stimulation, such as implanted active or passive biomedical devices, epilepsy, or severe venous insufficiency in the lower limbs

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Baseline and 12-month follow-up

Participants undergo gait analysis and magnetic resonance imaging to assess the functionality and pathological condition of the knee.

2 visits (in-person)

Long-term Monitoring

Duration - 12 months

Participants are monitored through strength measurements, bioimpedance analysis, gait analysis including electromyography, and clinical questionnaires at baseline and 12 months to evaluate knee function over time.

2 visits (in-person)

Trial Site Locations

Total: 1 location

1

IRCCS Istituto Ortopedico Rizzoli

Bologna, Italy, 40136

Actively Recruiting

Loading map...

Research Team

S

stefano zaffagnini

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

Similar Trials

A Master Protocol for Randomized, Placebo-Controlled Phase 2...

Osteoarthritis, Knee

Actively Recruiting

64 locations

A 48-Weeks, Phase 2b/3a, Double-Blind, Randomized, Placebo C...

Osteoarthritis, Knee

Actively Recruiting

9 locations

A Phase 3, Randomised, Double-Blind, Placebo-Controlled Mult...

Osteoarthritis, Knee

Actively Recruiting

56 locations

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here