Analysis of the Pathophysiological and Functional State of the Knee Joint

NCT ID: NCT06490770

Last Updated: 2025-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-09

Study Completion Date

2027-04-30

Brief Summary

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Osteoarthritis is the most common degenerative condition affecting the knee joint globally, with an incidence of about 7% of the population. In Italy, it affects approximately 3.9 million people, with a direct treatment cost of around €2.5 billion. At the joint level, osteoarthritis manifests with pain and reduced functionality, worsening as the disease progresses and severely limiting knee movement. Compounding this, osteoarthritis can impact both elderly and younger individuals due to traumatic factors.

Despite its significant impact, effective treatments for osteoarthritis that address its underlying causes are still lacking, focusing mainly on symptom management. Therefore, improving diagnostic and prognostic approaches is crucial to better understand its onset and progression.

MRI is a primary diagnostic tool for assessing the knee joint's pathophysiological state. It uses tissue-specific sequences to investigate joint homeostasis in detail, although it primarily provides insights into morphology, structure, and tissue composition rather than functional changes within the joint. This limitation is noteworthy because joint homeostasis involves complex interactions among biomechanical, structural, and biological processes, which are directly influenced by osteoarthritis.

Gait analysis provides valuable diagnostic information on joint function. By integrating sensor measurements and electronic systems with patient-specific musculoskeletal models derived from MRI morphometric data, it is possible to assess the forces and moments within the joint during specific movements.

Given that osteoarthritis affects the entire joint, employing multidisciplinary approaches can enhance diagnostic precision and provide insights into the progressive impact of degenerative conditions like osteoarthritis on joint health.

Detailed Description

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Conditions

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Osteoarthritis, Knee Cartilage Degeneration

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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group 1

Group Type OTHER

Gait analysis, Magnetic Resonance Imaging

Intervention Type DIAGNOSTIC_TEST

Gait analysis and Magnetic Resonance Imaging to investigate the functionality and the pathological condition of the knee, respectively

Interventions

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Gait analysis, Magnetic Resonance Imaging

Gait analysis and Magnetic Resonance Imaging to investigate the functionality and the pathological condition of the knee, respectively

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* History/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 (implanted active and passive biomedical devices, epilepsy, severe venous insufficiency in the lower limbs)
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istituto Ortopedico Rizzoli

OTHER

Sponsor Role lead

Responsible Party

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Stefano Zaffagnini

Full Professor Medicine and Surgery, University of Bologna

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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IRCCS Istituto Ortopedico Rizzoli

Bologna, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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stefano zaffagnini

Role: CONTACT

+390516366075

Facility Contacts

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Stefano Zaffagnini, MD

Role: primary

+39 051 6366075

Other Identifiers

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Gait-MRI-Knee

Identifier Type: -

Identifier Source: org_study_id

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