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

NCT03876795 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2023-04-19

No results posted yet for this study

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

Interventions

BIOLOGICAL

Bone Marrow Concentrate

Bone Marrow Concentrate injection

Sponsors & Collaborators

  • Istituto Ortopedico Rizzoli

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-08
Primary Completion
2023-03-01
Completion
2023-03-01

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03876795 on ClinicalTrials.gov