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RecruitingNCT05599841Updated Sep 21, 2023

Povidone Iodine Irrıgation at Hip-Knee Arthroplasty

An interventional study of PI solution and Saline Solution in Osteoarthritis, Hyperthyroidism and Iodine Toxicity, sponsored by Ankara University. Recruiting at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-21.

Sponsored by Ankara University · Not applicable, Interventional, and Screening

From the registry’s dates

  • Registered 3 years 9 months after the study started (first participant enrolled Jan 2019, registered Oct 2022).
  • Started Jan 2019; still recruiting 7 years 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Osteoarthritis
  • Hyperthyroidism
  • Iodine Toxicity
03

In context

Osteoarthritis

2,974 studies on the registry are indexed under Osteoarthritis; 438 are open to participants now.

This study's planned enrollment of 120 is above the median of 80 across 2,240 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

Ankara University is the lead sponsor of 320 studies on the registry; 64 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • All patients with hip/knee osteoarthritis who undergo primary arthroplasty

Exclusion criteria

Exclusion Criteria:

  • Patients with abnormal thyroid function tests in the preoperative period, a history of the previous thyroid-related disease.
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
120 participants (estimated)

Study arms

  • Active comparator
    Povidone Iodine Solution

    The group whom PI solution will be used at surgery

    Procedure: PI solution

  • Placebo comparator
    Saline Solution

    The group whom only saline solution will be used at surgery

    Procedure: Saline Solution

Interventions

  • ProcedurePI 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.

  • ProcedureSaline 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

06

What researchers measure

Primary outcomes

  1. Urine iodine level

    Urine iodine concentration

    Time frame: postoperative first day

Secondary outcomes

  1. Thyroid hormone

    Blood thyroid hormone levels including: TSH, T3 and T4

    Time frame: postoperative 14 days

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05599841
Lead sponsor
Ankara University
Responsible party
Hakan KOCAOGLU (M.D. Assoc. Prof., Ankara University) — Principal investigator
First posted
Oct 31, 2022
Start date
Jan 1, 2019
Primary completion
May 31, 2023
Completion
Sep 16, 2023 (estimated)
Last update
Sep 21, 2023

Study contacts

Hakan Kocaoglu, MD
Contact
kocaoglu@ankara.edu.tr
00903125082321
Hakan Kocaoglu, MD
principal investigator · Ankara University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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