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

NCT03876795 | Completed Phase 3

• 1 other identifier: INTERFACE
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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).

Conditions

Osteoarthritis, Knee

Keywords

Bone Marrow Comcentrate; intra-articular; intra-osseus

Outcome Measures

Primary Outcomes (1)

• 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.

  basal 2,6,12 months after treatment

Secondary Outcomes (1)

• IKDC Subjective Knee Evaluation Form (IKDC)

  2,6,12 months

Study Arms (2)

Single intra-articular Bone Marrow Concentrate injection

ACTIVE COMPARATOR

Single intra-articular Bone Marrow Concentrate injection in the knee

Biological: Bone Marrow Concentrate

combined Bone Marrow Concentrate injection

EXPERIMENTAL

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

Biological: Bone Marrow Concentrate

Interventions

Bone Marrow Concentrate BIOLOGICAL

Bone Marrow Concentrate injection

Single intra-articular Bone Marrow Concentrate injection; combined Bone Marrow Concentrate injection

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients, aged between 40 and 70;
• Arthrosis of the medial compartment (grade 2-3 according to the Kellgren-Lawrence score\> 4 months);
• Failure after at least 6 months of conservative treatment (drug therapy with NSAIDs and painkillers, hyaluronic acid infiltration, corticosteroid infiltration, PRP);
• Patients' ability and consent to participate in clinical and radiological follow-up;
• Signature of informed consent.

You may not qualify if:

• Patients with trauma in the 6 months prior to surgery;
• Patients with maligncy;
• Patients suffering from rheumatic diseases;
• Patients suffering from non-compensated diabetes;
• Patients suffering from uncompensated thyroid metabolic disorders;
• Patients abusing alcoholic beverages, drugs or drugs;
• Patients with axial deviations\> 5 °;
• Body Mass Index\> 35;
• Patients treated with joint infiltrations in the previous 6 months;
• Patients treated with surgery at the same knee in the previous 12 months.

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Rizzoli Orthopaedic Institute

Bologna, 40136, Italy

Location

Related Publications (1)

• 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.

  PMID: 36468635 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2019
• First Posted: March 15, 2019
• Study Start: November 8, 2019
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: April 19, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)