NCT04061733

New Hydroxyethyl Cellulose Hydrogel for the Treatment of the Pain of Knee Arthrosis

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Promedon · Industry
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Prospective, multicenter study, unmasked, single-arm, to study the safety and efficacy of a new hydroxyethyl cellulose hydrogel for the treatment of the knee pain caused by osteoarthritis.

Detailed description

Prospective, multicenter study, unmasked, single-arm, to study the safety and efficacy of a new hydroxyethyl cellulose hydrogel for the treatment of the knee pain caused by osteoarthritis. The working hypothesis is that the effect of hydrogel use on the study population will result in a reduction in pain in the knees affected by symptomatic OA. The general objective of this study is to generate clinical evidence of the safety and efficacy of the new hydrogel used as a treatment of symptomatic knee osteoarthritis. The patient's perception of the pain caused by osteoarthritis in the knee joint before and after the treatment under evaluation will be quantify. Subjects' quality of life before and after treatment will also be evaluated. Monitoring of the adverse events associated with the use of the device under evaluation will be determined. Subjects will be follow-up for 12 months.

Conditions

• Osteoarthritis, Knee
• Pain

Interventions

Type	Name	Description
DEVICE	Hydrogel injection	Hydrogel injection

Timeline

• Start date: 2019-09-30
• Primary completion: 2023-07-31
• Completion: 2024-07-31
• First posted: 2019-08-20
• Last updated: 2022-12-29

Locations

3 sites across 1 country: Argentina