Quantitative Assessment of BB-02 Therapy Effect on Cartilage Status in Patients Affected by Early Knee Osteoarthritis
NCT Number: NCT06459817
Acronym: JOCARE-OA
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Osteoarthritis, Knee
Interventions: DEVICE: BB-02 therapy
Sponsor: Istituto Ortopedico Rizzoli
Collaborators: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Sex: ALL
Age: ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2025-06

Summary:
Knee osteoarthritis is a condition that affects young or middle-aged patients with high functional demands. Knee replacement surgery in patients under 65 years of age is associated with a high risk of failure and the need for revision. For this reason, it becomes crucial to identify treatment alternatives aimed primarily at resolving symptoms but also at slowing down the joint degenerative process, with the goal of delaying the need for prosthetic treatment as much as possible. The medical device BB-02 (IGEA SpA, Carpi, Italy) is a certified medical device according to Regulation (EU) 2017/745 (MDR) for the treatment of inflammatory and degenerative tissue pathologies and represents an effective tool in the treatment of early and intermediate osteoarthritis. To date, the demonstration of the efficacy of BB-02 therapy has been measured through the evaluation of clinical endpoints, using both objective and subjective assessment scales. So far, there is a lack of instrumental measurement of the ability of BB-02 therapy to preserve the integrity of the articular cartilage.

The primary objective of the study is to evaluate, through magnetic resonance imaging (MRI), the effect of pulsed electromagnetic fields administered via BB-02 therapy on cartilage damage in subjects with early-stage osteoarthritis. The BB-02 device was chosen based on promising results reported in the pre-clinical phase of experimentation.

The secondary objective is to assess the effect of BB-02 therapy on pain resolution and clinical scores of knee functionality in the two different therapeutic regimens.

Primary Outcome Measures: 3 Tesla Magnetic Resonance Imaging (MRI), with T2 mapping sequences in patients with knee osteoarthritis before and after treatment with two different therapeutic regimens of BB-02 therapy, 12 months
Secondary Outcome Measures: visual analog scale (vas), It is a one-dimensional quantitative numeric pain rating scale with 10 points; the scale requires the patient to select the number that best describes the intensity of their pain, from 0 to 10, at the time of the visit and before the surgery. 0 means no pain and 10 indicates the worst possible pain., 12 months|Knee Society Score (KSS), The Knee Society Score (KSS) is a comprehensive system used to evaluate knee joint condition and functionality, especially before and after knee replacement surgery. It consists of two parts: the Knee Score, assessing pain, range of motion, stability, and alignment, and the Function Score, evaluating the patient's ability to perform daily activities like walking and climbing stairs. Both scores can reach up to 100 points, with higher scores indicating better knee health and function. KSS is widely used to assess surgical outcomes and track patient progress., 12 months|Tegner Activity Score (TAS), It allows for estimating the level of motor activity of an individual with a score between 0 and 10, where 0 represents ''incapacity'' and 10 represents ''participation in competitive sports, such as national or international level soccer.' This score is the most commonly used to define the level of motor activity in patients with knee disorders. The patient will also be asked how many years they have been active in sports and whether the cause of reduction or cessation of activity is related to their knee condition or not., 12 months|Degree of patient compliance with the treatment, The patient's ability to adhere correctly, in methods and timing, to a therapy indicated by their doctor, without the possibility of altering the therapeutic treatment in order to comply with the study group and the clinical protocol., 12 months