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Safety of Use and Efficacy of Pandora for Patients Suffering From Gonarthrosis (PANDORA2)

NCT05978180 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 252

Last updated 2025-12-22

No results posted yet for this study

Summary

The knee osteoarthritis is a frequent degenerative condition that mainly affects subjects over 60, population often weakened by numerous comorbidities and concomitant treatments, justifying the development of new therapies.

The viscosupplementation is a symptomatic treatment for knee osteoarthritis ; the objective of this intra-articular injection of hyaluronic acid is to reduce knee pain and improve mobility. In practice, there are two protocols to administer viscosupplementation : in a single injection or in three injections performed weekly.

The present clinical investigation has the objective to evaluate the safety and efficacy of use of Pandora, a hyaluronic acid associated with tranexamic acid, in a single injection (HO-1) or in three injections performed weekly (HS-3), compared to a referred and commercialized medical device.

Conditions

Interventions

DEVICE

Medical Device : HO-1

The injection will be performed at Day 1.

DEVICE

Medical Device : HS-3

The three injections will be performed at Days 1, 8 and 15.

DEVICE

Medical Device : SINOVIAL® ONE

The injection will be performed at Day 1.

Sponsors & Collaborators

  • Statitec

    collaborator INDUSTRY

  • Labrha

    lead INDUSTRY

Principal Investigators

  • Patrick Sac-Epee · Labrha

  • Jean-Charles Balblanc, Dr · Hôpital Nord Franche-Comté, HNFC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-18
Primary Completion
2025-11-13
Completion
2025-11-13

Countries

  • France
  • Monaco

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 NCT05978180 on ClinicalTrials.gov