Povidone Iodine Irrıgation at Hip-Knee Arthroplasty

Sponsor

Ankara University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05599841

Collaborator

(none)

120

Enrollment

Location

Arms

Anticipated Duration (Months)

29.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis Hyperthyroidism Iodine Toxicity	Procedure: PI solution Procedure: Saline Solution	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Screening

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

Actual Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Feb 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Urine iodine level [postoperative first day]
Urine iodine concentration

Secondary Outcome Measures

Thyroid hormone [postoperative 14 days]
Blood thyroid hormone levels including: TSH, T3 and T4

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ankara University Faculty of Medicine	Ankara		Turkey	06100

Sponsors and Collaborators

Ankara University

Investigators

Principal Investigator: Hakan Kocaoglu, MD, Ankara University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hakan KOCAOGLU, M.D. Assoc. Prof., Ankara University

ClinicalTrials.gov Identifier:

NCT05599841

Other Study ID Numbers:

Orthop2180

First Posted:

Oct 31, 2022

Last Update Posted:

Oct 31, 2022

Last Verified:

Oct 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Hyperthyroidism

Pharmaceutical Solutions

Study Results

No Results Posted as of Oct 31, 2022