Evaluation of Effectiveness of Combined Intra-articular and Intra-osseus Injection VS a Single Intra-articular Injection of Bone Marrow Concentrate

NCT ID: NCT03876795

Last Updated: 2023-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-08
• Study Completion Date: 2023-03-01

Brief Summary

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).

Detailed Description

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.

Conditions

Osteoarthritis, Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Single intra-articular Bone Marrow Concentrate injection

Single intra-articular Bone Marrow Concentrate injection in the knee

Group Type: ACTIVE_COMPARATOR

Bone Marrow Concentrate

Intervention Type: BIOLOGICAL

Bone Marrow Concentrate injection

combined Bone Marrow Concentrate injection

combined Bone Marrow Concentrate injection (intra-articular and intra-osseus)

Group Type: EXPERIMENTAL

Bone Marrow Concentrate

Intervention Type: BIOLOGICAL

Bone Marrow Concentrate injection

Interventions

Bone Marrow Concentrate

Bone Marrow Concentrate injection

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Male or female patients, aged between 40 and 70;

2. Arthrosis of the medial compartment (grade 2-3 according to the Kellgren-Lawrence score> 4 months);

3. Failure after at least 6 months of conservative treatment (drug therapy with NSAIDs and painkillers, hyaluronic acid infiltration, corticosteroid infiltration, PRP);

4. Patients' ability and consent to participate in clinical and radiological follow-up;

5. Signature of informed consent.

Exclusion Criteria

1. Patients with trauma in the 6 months prior to surgery;

2. Patients with maligncy;

3. Patients suffering from rheumatic diseases;

4. Patients suffering from non-compensated diabetes;

5. Patients suffering from uncompensated thyroid metabolic disorders;

6. Patients abusing alcoholic beverages, drugs or drugs;

7. Patients with axial deviations> 5 °;

8. Body Mass Index> 35;

9. Patients treated with joint infiltrations in the previous 6 months;

10. Patients treated with surgery at the same knee in the previous 12 months.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Ortopedico Rizzoli

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Rizzoli Orthopaedic Institute

Bologna, , Italy

Countries

Italy

References

Silva S, Andriolo L, Boffa A, Di Martino A, Reale D, Vara G, Miceli M, Cavallo C, Grigolo B, Zaffagnini S, Filardo G. Prospective double-blind randomised controlled trial protocol comparing bone marrow aspirate concentrate intra-articular injection combined with subchondral injection versus intra-articular injection alone for the treatment of symptomatic knee osteoarthritis. BMJ Open. 2022 Sep 8;12(9):e062632. doi: 10.1136/bmjopen-2022-062632.

Reference Type: DERIVED

PMID: 36468635 (View on PubMed)

Other Identifiers

INTERFACE

Identifier Type: -

Identifier Source: org_study_id