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

NCT03445611 · Status: WITHDRAWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL

Last updated 2021-06-03

No results posted yet for this study

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.

Conditions

  • Osteoarthritis, Knee

Interventions

DRUG

corticosteroid solution with lidocaine containing parabens.

To identify whether corticosteroid use with anesthetics containing parabens reduces clinical effectiveness relative to para-free preparations.

DRUG

corticosteroid solution with lidocaine containing no paraben

To identify whether corticosteroid use with anesthetics containing parabens reduces clinical effectiveness relative to para-free preparations.

Sponsors & Collaborators

  • Loma Linda University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-09-15
Primary Completion
2019-10-15
Completion
2019-10-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03445611 on ClinicalTrials.gov