Quantitative Assessment of BB-02 Therapy Effect on Cartilage Status in Patients Affected by Early Knee Osteoarthritis
Key facts
- Who runs it
- Stefano Zaffagnini
- Where
- Italy1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 30 people enrolled
- Started
- 10 Jul 2024
- Ended
- 12 May 2026
- Type of study
- Interventional, 2 groups
- Treatments tested
- BB-02 therapy
- Record updated
- 2 July 2026
Who can take part
- Age
- 20 years to 55 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 17 criteriaShow less
Who can take part
- Both sexes aged between 20 and 55 years
- Body Mass Index, BMI < 35
- Subjects with Kellgren-Lawrence grade 2 osteoarthritis
- Subjects with baseline Visual Analog Scale (VAS) score ≥ 2
- Mechanical alignment between 175° and 185°
- Absence of acute ligamentous or meniscal pathology
Who cannot take part
- Knee arthroscopy within the 12 months prior to enrollment
- Patients undergoing analgesic therapy with opioids, systemic corticosteroids, or intra-articular corticosteroids during study participation
- Patients with systemic inflammatory or neoplastic diseases
- Individuals with hypertension or diabetes
- Subjects diagnosed with inflammatory arthritis (rheumatoid arthritis, gout, joint infections, Lyme disease, lupus, etc.)
- Subjects diagnosed with secondary arthritis (acromegaly, Charcot arthropathy, hemochromatosis, Wilson's disease, ochronosis, anterior cruciate ligament injuries)
- Smokers
- Patients undergoing intra-articular injections of hyaluronic acid during the study participation
- Patients unable to provide informed consent
- Pregnant and breastfeeding women
- Women in menopause
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
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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.
The 2 groups in the trial
- group 1Treatment being tested
BB-02 therapy. 1h a day for 3 months
Treatment: BB-02 therapy
- group 2Treatment being tested
BB-02 therapy. 4h a day for 1 month
Treatment: BB-02 therapy
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 2 July 2026