Clinical trial NCT06490770: Analysis of the Pathophysiological and Functional State of the Knee Joint
Official title: Analysis of the Pathophysiological and Functional State of the Knee Joint
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Osteoarthritis, Knee
Cartilage Degeneration
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2024-07-08
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Magnetic Resonance Imaging
timeFrame: at baseline and 12-month follow-up
Secondary outcomes:
measure: Strength measurements with a manual dynamometer
timeFrame: at baseline and 12-month follow-up
measure: Bioimpedance analysis
timeFrame: at baseline and 12-month follow-up
measure: Gait Analysis (including Electromyography)
timeFrame: at baseline and 12-month follow-up
measure: Clinical questionnaires
timeFrame: at baseline and 12-month follow-up
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Istituto Ortopedico Rizzoli
Study officials:
References: