Assessing BB-02 Therapy for Early Knee Osteoarthritis
Quantitative Assessment of BB-02 Therapy Effect on Cartilage Status in Patients Affected by Early Knee Osteoarthritis
This study is testing a new therapy called BB-02 to see if it can help younger people with early knee osteoarthritis feel better and delay the need for knee replacement surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 20 Years to 55 Years |
| Sex | All |
| Sponsor | Istituto Ortopedico Rizzoli Academic / other |
| Locations | 1 site (Bologna) |
| Trial ID | NCT06459817 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of BB-02 therapy in patients with early knee osteoarthritis, focusing on its impact on cartilage health. The approach involves using a certified medical device designed to treat inflammatory and degenerative conditions, aiming to alleviate symptoms and slow the degenerative process of the knee joint. Participants will be assessed through both clinical endpoints and instrumental measurements to quantify the therapy's potential benefits. The goal is to provide a non-surgical alternative to delay the need for knee replacement surgery in younger patients.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 20 to 55 with Kellgren-Lawrence grade 2 osteoarthritis and a baseline VAS score of 2 or higher.
Not a fit: Patients with systemic inflammatory diseases, significant comorbidities, or recent knee surgeries are unlikely to benefit from this therapy.
Why it matters
Potential benefit: If successful, this therapy could significantly improve the quality of life for patients with early knee osteoarthritis by preserving joint function and delaying the need for surgery.
How similar studies have performed: While there is limited evidence on the effectiveness of similar non-surgical treatments, this approach aims to fill a gap in current osteoarthritis management strategies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Patients with systemic inflammatory or neoplastic diseases * Smokers * Individuals with hypertension or diabetes * Knee arthroscopy within the 12 months prior to enrollment * 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) * Patients undergoing analgesic therapy with opioids, systemic corticosteroids, or intra-articular corticosteroids during study participation * 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
Where this trial is running
Bologna
- Istituto Ortopedico Rizzoli — Bologna, Italy (Recruiting)
Study contacts
- Study coordinator: Stefano Zaffagnini, Professor
- Email: stefano.zaffagnini@ior.it
- Phone: 0516366075
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.