Quantitative Assessment of BB-02 Therapy Effect on Cartilage Status in Patients Affected by Early Knee Osteoarthritis

NCT06459817 | Recruiting DMC

• 1 other identifier: JOCARE-OA
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteoarthritis, Knee

Keywords

knee; osteoarthritis; preserving treatment; mri; Biophysical stimulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• visual analog scale (vas)

  12 months

• Knee Society Score (KSS)

  12 months

• Tegner Activity Score (TAS)

  12 months

• Degree of patient compliance with the treatment

  12 months

Study Arms (2)

group 1

EXPERIMENTAL

BB-02 therapy. 1h a day for 3 months

Device: BB-02 therapy

group 2

EXPERIMENTAL

BB-02 therapy. 4h a day for 1 month

Device: BB-02 therapy

Interventions

BB-02 therapy DEVICE

Biophysical stimulation with magnetic fields

group 1; group 2

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead
• I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio: collaborator

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

RECRUITING

Related Publications (5)

• Adravanti P, Nicoletti S, Setti S, Ampollini A, de Girolamo L. Effect of pulsed electromagnetic field therapy in patients undergoing total knee arthroplasty: a randomised controlled trial. Int Orthop. 2014 Feb;38(2):397-403. doi: 10.1007/s00264-013-2216-7. Epub 2013 Dec 20.

  PMID: 24352823 RESULT

• Benazzo F, Cadossi M, Cavani F, Fini M, Giavaresi G, Setti S, Cadossi R, Giardino R. Cartilage repair with osteochondral autografts in sheep: effect of biophysical stimulation with pulsed electromagnetic fields. J Orthop Res. 2008 May;26(5):631-42. doi: 10.1002/jor.20530.

  PMID: 18176941 RESULT

• Cadossi M, Buda RE, Ramponi L, Sambri A, Natali S, Giannini S. Bone marrow-derived cells and biophysical stimulation for talar osteochondral lesions: a randomized controlled study. Foot Ankle Int. 2014 Oct;35(10):981-7. doi: 10.1177/1071100714539660. Epub 2014 Jun 10.

  PMID: 24917648 RESULT

• Moretti L, Bizzoca D, Giancaspro GA, Cassano GD, Moretti F, Setti S, Moretti B. Biophysical Stimulation in Athletes' Joint Degeneration: A Narrative Review. Medicina (Kaunas). 2021 Nov 4;57(11):1206. doi: 10.3390/medicina57111206.

  PMID: 34833424 RESULT

• Perdisa F, Bordini B, Salerno M, Traina F, Zaffagnini S, Filardo G. Total Knee Arthroplasty (TKA): When Do the Risks of TKA Overcome the Benefits? Double Risk of Failure in Patients up to 65 Years Old. Cartilage. 2023 Sep;14(3):305-311. doi: 10.1177/19476035231164733. Epub 2023 Apr 19.

  PMID: 37073516 RESULT

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Stefano Zaffagnini, Professor

CONTACT

0516366075; stefano.zaffagnini@ior.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2024
• First Posted: June 14, 2024
• Study Start: July 10, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: July 11, 2025

Record last verified: 2025-07

Locations

IT (1)