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
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2019
CompletedFirst Submitted
Initial submission to the registry
October 26, 2022
CompletedFirst Posted
Study publicly available on registry
October 31, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 16, 2023
CompletedSeptember 21, 2023
September 1, 2023
4.4 years
October 26, 2022
September 16, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Urine iodine level
Urine iodine concentration
postoperative first day
Secondary Outcomes (1)
Thyroid hormone
postoperative 14 days
Study Arms (2)
Povidone Iodine Solution
ACTIVE COMPARATORThe group whom PI solution will be used at surgery
Saline Solution
PLACEBO COMPARATORThe group whom only saline solution will be used at surgery
Interventions
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.
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
Eligibility Criteria
You may qualify if:
- All patients with hip/knee osteoarthritis who undergo primary arthroplasty
You may not qualify if:
- Patients with abnormal thyroid function tests in the preoperative period, a history of the previous thyroid-related disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ankara University Faculty of Medicine
Ankara, 06100, Turkey (Türkiye)
Related Publications (1)
Ertan MB, Basarir K, Kocaoglu H, Aydugan MY, Gungor E. Systemic iodine levels increase with povidone-iodine irrigation, but does this affect thyroid functions? A case-control study. J Orthop Surg Res. 2024 Oct 8;19(1):636. doi: 10.1186/s13018-024-04877-8.
PMID: 39380015DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hakan Kocaoglu, MD
Ankara University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D. Assoc. Prof.
Study Record Dates
First Submitted
October 26, 2022
First Posted
October 31, 2022
Study Start
January 1, 2019
Primary Completion
May 31, 2023
Study Completion
September 16, 2023
Last Updated
September 21, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share