MedTrace Logo

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

NCT06238934 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2024-02-02

No results posted yet for this study

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

Interventions

BIOLOGICAL

Bone marrow aspirate matrix

Bone marrow aspirate \* Hyaluronic acid

BIOLOGICAL

Bone marrow aspirate

Bone marrow aspirate

DEVICE

Hyaluronic acid

Hyaluronic acid

Sponsors & Collaborators

  • Instituto Nacional de Traumatologia e Ortopedia

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-03-31
Primary Completion
2025-03-31
Completion
2027-03-31

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

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 NCT06238934 on ClinicalTrials.gov