Povidone Iodine Irrıgation at Hip-Knee Arthroplasty

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

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.

Study Overview

• Status: Recruiting
• Conditions: Osteoarthritis; Hyperthyroidism; Iodine Toxicity
• Intervention / Treatment: Procedure: PI solution; Procedure: Saline Solution

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hakan Kocaoglu, MD; Phone Number: 00903125082321; Email: kocaoglu@ankara.edu.tr

Study Locations

• Turkey
  • Ankara, Turkey, 06100
    • Recruiting
    • Ankara University Faculty of Medicine
    • Contact: Hakan Kocaoglu, MD; Phone Number: 00903125082321; Email: kocaoglu@ankara.edu.tr
    • Contact: Mehmet Batu Ertan, MD; Phone Number: 00903542190010; Email: mbatuertan@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Povidone Iodine Solution; The group whom PI solution will be used at surgery	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.
Placebo Comparator: Saline Solution; The group whom only saline solution will be used at surgery	Procedure: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urine iodine level	Urine iodine concentration	postoperative first day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thyroid hormone	Blood thyroid hormone levels including: TSH, T3 and T4	postoperative 14 days

Collaborators and Investigators

• Sponsor: Ankara University
• Investigators: Principal Investigator: Hakan Kocaoglu, MD, Ankara University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): May 31, 2023
• Study Completion (Estimated): September 16, 2023

Study Registration Dates

• First Submitted: October 26, 2022
• First Submitted That Met QC Criteria: October 26, 2022
• First Posted (Actual): October 31, 2022

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 16, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Thyroid Diseases; Hyperthyroidism; Pharmaceutical Solutions
• Other Study ID Numbers: Orthop2180

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No