Parabens Flocculation on the Anti Inflammatory Effects of Corticosteroid Injections for Total Knee Arthroplasty

• Status: Withdrawn
• Trial end date: 2019-10-30
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to identify whether corticosteroid use with anesthetics containing preservatives (parabens) reduces clinical effectiveness of the anti-inflammatory agent Up to 100 patients, both male and female, between the ages of 18-89 will be enrolled and randomized into either of the following groups; Group 1: These patients will receive a corticosteroid solution with lidocaine containing parabens.

Group 2: These patients will receive corticosteroid solution with paraben free lidocaine.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Loma Linda University
• Treatments: Lidocaine; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• Diagnosis of symptomatic primary knee osteoarthritis according to the American Rheumatism Association classification criteria for knee osteoarthritis, ability to understand study protocol and agreement to participate

Exclusion Criteria:

• History of any knee injection in the past 6 months, History of more than 2 injections in the knee under study, previous fracture or surgical procedure of knee under investigation, any benign or malignant tumor in knee, chemotherapy, hemearthosis, current infection in the affected limb.