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

NCT03445611 | Withdrawn Early Phase 1 FDA Drug

• 1 other identifier: 5160373
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• WOMAC-Western Ontario and McMaster Universities Osteoarthritis Index

  This is a survey that asks your view about your knee. This information will help track how you feel about your knee and how well you are able to do your usual activities

  6 months

Secondary Outcomes (1)

• VAS-Visual Analogue Scale

  6 months

Study Arms (2)

Group 1

EXPERIMENTAL

These patients will receive a corticosteroid solution with lidocaine containing parabens.

Drug: corticosteroid solution with lidocaine containing parabens.

Group 2

ACTIVE COMPARATOR

These patients will receive corticosteroid solution with paraben free lidocaine.

Drug: corticosteroid solution with lidocaine containing no paraben

Interventions

corticosteroid solution with lidocaine containing parabens. DRUG

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

Group 1

corticosteroid solution with lidocaine containing no paraben DRUG

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

Group 2

Eligibility Criteria

• Age: 19 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University Health, Department of Orthopaedic Surgery

Loma Linda, California, 92354, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: randomized into either Group1 or Group 2 medication with or without presevatives.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2017
• First Posted: February 26, 2018
• Study Start: September 15, 2019
• Primary Completion: October 15, 2019
• Study Completion: October 30, 2019
• Last Updated: June 3, 2021

Record last verified: 2021-06

Locations

US (1)