MedTrace Logo

Assessment of Efficacy of a Single Intra-articular Injection of HYALUBRIX 60 in Knee Osteoarthritis

NCT06113783 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-07-29

No results posted yet for this study

Summary

The purpose of this study is to evaluate the effect of one single intra-articular (IA) injection of HYALUBRIX 60® plus physical exercise program (PEP) in terms of pain reduction, compared to PEP alone, in patients with knee osteoarthritis (OA).

Conditions

Interventions

DEVICE

HYALUBRIX 60

1.5% solution of non-modified HA (60mg/4ml) obtained from bacterial fermentation with high molecular weight.

Sponsors & Collaborators

  • Fidia Farmaceutici s.p.a.

    lead INDUSTRY

Principal Investigators

  • Valter Santilli · UOC Medicina Fisica e Riabilitativa SMC09, AOU Policlinico Umberto I, Rome, Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-06-16
Primary Completion
2024-12-31
Completion
2026-03-31

Countries

  • Italy

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 NCT06113783 on ClinicalTrials.gov