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Intra-articular Administration of Med Device Made of Biological Vegetal Matrix for the Treatment of Knee Osteoarthritis

NCT05925595 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-04-17

No results posted yet for this study

Summary

A pre-market randomized, parallel group, single-blind, clinical study with a Medical Device, made of vegetal material, to evaluate the efficacy and safety of one knee injection of the investigational device versus active comparator (Jonexa). The study population will consist of 150 patients diagnosed with primary knee osteoarthrosis. At present, the study is monocentric competitive.

Treatment period for each patient is 6 months.

Conditions

  • the Treatment of Knee Osteoarthritis

Interventions

DEVICE

Medical Device Iniettabile Ginocchio

Knee injection of the investigational device( MD Iniettabile Ginocchio) versus active comparator (Jonexa).

Sponsors & Collaborators

  • Iqvia Pty Ltd

    collaborator INDUSTRY

  • Bios-Therapy, Physiological Systems for Health S.p.A

    lead INDUSTRY

Principal Investigators

  • Auro Caraffa, MD · Azienda Ospedaliera di Perugia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-06
Primary Completion
2024-10-10
Completion
2024-10-10

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 NCT05925595 on ClinicalTrials.gov