NCT05414617

Safety of Use of Pandora for Patients Suffering From Gonarthrosis

Prospective, Multicenter, Open Study Evaluating the Short-term Safety of Use of Pandora Administered in the Form of 1 Intra-articular Injection of Happyone or 3 Intra-articular Injections of Happysoft in Patients Suffering From Gonarthrosis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Labrha · Industry
• Sex: All
• Age: 35 Years – 85 Years
• Healthy volunteers: Not accepted

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 of use of Pandora in a single injection or in three injections performed weekly.

Detailed description

This clinical investigation is a multicenter, prospective, open study of a class III Medical Device. This study is designed to evaluate the safety of use of Pandora in its two forms : in a single injection or in three injections. A descriptive analysis will be carried out to characterize the demographic data, the history of the disease and its treatments, the clinical and radiological data of the patients at inclusion. The security of use of Pandora will be demonstrated by describing the proportion of patients with at least one adverse event attributable to the treatment, occurring during the week following each injection. In total, 20 participants will be enrolled across two study centers in France, 10 participants in each centers. The total duration of subjects participation is 6 months ; overall study duration including the enrollment period is expected to take approximately 9 months.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
DEVICE	Intra-articular single injection	Both groups will receive their first injection after a selection visit ; first injection will be planned between 7 days to 30 days after to confirm the enrollment. The injection will be performed at Day 1.
DEVICE	Intra-articular three injections	Both groups will receive their first injection after a selection visit ; first injection will be planned between 7 days to 30 days after to confirm the enrollment. The injections will be performed at Days 1, 8 and 15.

Timeline

• Start date: 2022-06-08
• Primary completion: 2023-01-18
• Completion: 2023-06-14
• First posted: 2022-06-10
• Last updated: 2023-06-22

Locations

2 sites across 1 country: France