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NCT05599841 Clinical Trial

Povidone Iodine Irrıgation at Hip-Knee Arthroplasty

Osteoarthritis Clinical Trial

Official title:
Evaluation of the Systemic Effect of Intraoperative Diluted Povidone Iodine Irrigation Using Urine Iodine and Thyroid Function Tests in Patients Undergoing Knee-Hip Arthroplasty

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05599841
Other study ID # Orthop2180
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2019
Est. completion date September 16, 2023

Study information
Verified date September 2023
Source Ankara University
Contact Hakan Kocaoglu, MD
Phone 00903125082321
Email kocaoglu@ankara.edu.tr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Povidone iodine (PI) solution is an antimicrobial solution that can be used at hip and knee arthroplasty cases. It contains iodine that may be absorbed by the body. This study aims to investigate any absorption caused by PI solution.

Recruitment information / eligibility
Status Recruiting
Enrollment 120
Est. completion date September 16, 2023
Est. primary completion date May 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - All patients with hip/knee osteoarthritis who undergo primary arthroplasty Exclusion Criteria: - Patients with abnormal thyroid function tests in the preoperative period, a history of the previous thyroid-related disease.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• PI solution
3,000 cc of <2% concentrated povidone iodine solution will be used as irrigation solution at primary hip/knee arthroplasty. The PI solution was left in the joint for 3 minutes.
• Saline Solution
3,000 cc of 0.9% saline solution will be used as irrigation solution at primary hip/knee arthroplasty. The saline solution was left in the joint for 3

Locations
Country Name City State
Turkey Ankara University Faculty of Medicine Ankara

Sponsors (1)
Lead Sponsor Collaborator
Ankara University

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Urine iodine level Urine iodine concentration postoperative first day
Secondary Thyroid hormone Blood thyroid hormone levels including: TSH, T3 and T4 postoperative 14 days
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