Back to resultsPovidone Iodine Irrıgation at Hip-Knee Arthroplasty
Primary Purpose
Osteoarthritis, Hyperthyroidism, Iodine Toxicity
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
PI solution
Saline Solution
Sponsored by
About this trial
This is an interventional screening trial for Osteoarthritis
Eligibility Criteria
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.
Sites / Locations
- Ankara University Faculty of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Povidone Iodine Solution
Saline Solution
Arm Description
The group whom PI solution will be used at surgery
The group whom only saline solution will be used at surgery
Outcomes
Primary Outcome Measures
Urine iodine level
Urine iodine concentration
Secondary Outcome Measures
Thyroid hormone
Blood thyroid hormone levels including: TSH, T3 and T4
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05599841
Brief Title
Povidone Iodine Irrıgation at Hip-Knee Arthroplasty
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
May 31, 2023 (Actual)
Study Completion Date
September 16, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara University
4. Oversight
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
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Hyperthyroidism, Iodine Toxicity
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Povidone Iodine Solution
Arm Type
Active Comparator
Arm Description
The group whom PI solution will be used at surgery
Arm Title
Saline Solution
Arm Type
Placebo Comparator
Arm Description
The group whom only saline solution will be used at surgery
Intervention Type
Procedure
Intervention Name(s)
PI solution
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Saline Solution
Intervention Description
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
Primary Outcome Measure Information:
Title
Urine iodine level
Description
Urine iodine concentration
Time Frame
postoperative first day
Secondary Outcome Measure Information:
Title
Thyroid hormone
Description
Blood thyroid hormone levels including: TSH, T3 and T4
Time Frame
postoperative 14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hakan Kocaoglu, MD
Phone
00903125082321
Email
kocaoglu@ankara.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hakan Kocaoglu, MD
Organizational Affiliation
Ankara University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ankara University Faculty of Medicine
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hakan Kocaoglu, MD
Phone
00903125082321
Email
kocaoglu@ankara.edu.tr
First Name & Middle Initial & Last Name & Degree
Mehmet Batu Ertan, MD
Phone
00903542190010
Email
mbatuertan@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Povidone Iodine Irrıgation at Hip-Knee Arthroplasty
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