A Phase 3 interventional study of Bone Marrow Concentrate in Osteoarthritis, Knee, sponsored by Istituto Ortopedico Rizzoli. Completed at 1 site in Italy. Open to participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-04-19.
Sponsored by Istituto Ortopedico Rizzoli · Phase 3, Interventional, and Treatment
Osteoarthritis (OA) is one of the most common diseases resulting in large burdens on society.
Among the emerging treatments, Bone Marrow Concentrate (BMC) intra-articular injections are a promising regenerative approach. However, they offer only a temporary benefit since they target synovial and chondral tissues but fail to address the osteochondral interface, which plays a key role in the onset and progression of joint degeneration.
This project will investigate the efficacy of combined BMC injections, targeting both intra-articular tissues and subchondral bone, to treat OA in a Randomized Controlled Trial (RCT).
The main aim is to evaluate in a RCT the potential of a new combined BMC treatment for OA, through the use of scores for the clinical outcome, the study of imaging and biological samples for tissue regeneration and systemic effects, and the identification of BMC and patient characteristics predictive of better results.
All patients will undergo an arthroscopic procedure to debride degenerated tissues (this can offer a temporary benefit but not long lasting results) before BMC intra-articular injection. Half patients will receive also the injection of BMC at the subchondral level (bone samples obtained to allow BMC placement will be sent to the Lab).
The same minimally invasive incisions will be used for all patients, ensuring patient blinding. Evaluations, performed by medical staff not involved in the treatment to ensure double blinding, will document subjective clinical improvement, functional measurements, biomarker study, and imaging with the use of modern 3TMRI and qCT technology. BMC characterization and patient features will be analysed to identify factors predictive of a better outcome.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 86 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Istituto Ortopedico Rizzoli is the lead sponsor of 298 studies on the registry; 102 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Single intra-articular Bone Marrow Concentrate injection in the knee
Biological: Bone Marrow Concentrate
combined Bone Marrow Concentrate injection (intra-articular and intra-osseus)
Biological: Bone Marrow Concentrate
Bone Marrow Concentrate injection
change of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score trend over time
WOMAC is a validated score, designed to highlight the problems of patients with lower limb pathologies, in particular in terms of pain, stiffness and functionality. The score will be completed by the patient, possibly in the presence of an investigator, and simple guidelines for self-compilation will be provided.
Time frame: basal 2,6,12 months after treatment
IKDC Subjective Knee Evaluation Form (IKDC)
IKDC is a validated score used in the evaluation of symptoms, function and sport activity in patients suffering of knee diseases, such as meniscal or ligamentous damage, osteoarthritis. The Subjective Knee Form provides the best method of overall assessment of the most significant symptoms and disabilities for a population that has undergone cartilage repair treatments.
Time frame: 2,6,12 months
Plan to share: No
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This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Istituto Ortopedico Rizzoli