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Knee Osteoarthritis Treatment With Platelet-rich Plasma

NCT05824806 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2024-05-31

No results posted yet for this study

Summary

Knee osteoarthritis (KOA) is a disease characterized by cartilage degeneration, synovium inflammation, bone remodeling, osteophyte formation, inflammations and loss of articular function. Interest on biological therapies has increased due to the recent update on KOA and its natural history. Viscosupplementation with hyaluronic acid aims to restore rheological properties of synovial fluid. Platelet rich plasma (PRP) is an autologous blood product which contains an elevated platelet concentration above the one found in blood. The goal of this study is to compare the clinical results of intra articular infiltration of hyaluronic and platelet rich plasma in the treatment of KOA, and to establish a protocol for PRP obtaining and prepare. Patients form the OA treating program will be selected and randomized into three groups (treatment with hyaluronic acid or onte of the two PRP protocols, PRP A and PRP B). Evaluation will include: subjective functional evaluation, clinical evaluation, radiological evaluation and radiological evaluation, which will be performed before treatment and 3 weeks, 3 months, 6 months and 1 year after treatment. Evaluation of PRP composition will be performed using ELISA/LUMINEX.

Key words: Knee, osteoarthritis, platelet rich plasma, viscosupplementation.

Conditions

  • Osteoarthritis, Knee

Interventions

BIOLOGICAL

PRP Protocol A

Platelet rich plasma protocol A

BIOLOGICAL

PRP Protocol B

Platelet rich plasma protocol B

DEVICE

Hyaluronic acid

Hyaluronic acid

Sponsors & Collaborators

  • Rio de Janeiro State Research Supporting Foundation (FAPERJ)

    collaborator OTHER_GOV

  • Instituto Nacional de Traumatologia e Ortopedia

    lead OTHER_GOV

Principal Investigators

  • Eduardo B Sousa, MD, PhD · INTO

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-08-31
Primary Completion
2025-08-31
Completion
2026-07-31

Countries

  • Brazil

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 NCT05824806 on ClinicalTrials.gov