NCT06238934

Treatment of Knee Osteoarthritis With Bone Marrow Aspirate Matrix: Prospective, Randomized Trial

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Instituto Nacional de Traumatologia e Ortopedia · Other Government
• Sex: All
• Age: 40 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Knee osteoarthritis (KOA) first manifests itself as a molecular derangement followed by anatomical and/or physiological changes. Conservative treatment of osteoarthritis should be the first approach to patients with this disease. The interest in biological therapies, including viscosupplementation and cell therapy, involves the recent update in knowledge about the pathophysiology of OA and its natural history. The aim of the present study is to compare the clinical results of intra-articular hyaluronic acid infiltration (IHA), bone marrow aspirate (BMA) and BMA matrix in the treatment of knee osteoarthritis. The sample will consist of 90 patients with osteoarthritis of the knee followed up at the INTO, who will be divided into three groups: group A, treatment with BMA; group B, treatment with IHA ; and group C, treatment with BMA matrix. Patients will be submitted to clinical, subjective functional and radiographic evaluation by an observer independent of the one who applied the selected treatment, at moments before application and 3 months, 6 months and 12 months after application. We believe that treatment with BMA and the BMA matrix have a better effect in improving symptoms and for a longer period of time than treatment with hyaluronic acid.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
BIOLOGICAL	Bone marrow aspirate matrix	Bone marrow aspirate \* Hyaluronic acid
BIOLOGICAL	Bone marrow aspirate	Bone marrow aspirate
DEVICE	Hyaluronic acid	Hyaluronic acid

Timeline

• Start date: 2024-03-01
• Primary completion: 2025-03-01
• Completion: 2027-03-01
• First posted: 2024-02-02
• Last updated: 2024-02-02

Locations

1 site across 1 country: Brazil