Povidone Iodine Irrıgation at Hip-Knee Arthroplasty

NCT ID: NCT05599841

Last Updated: 2023-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2023-09-16

Brief Summary

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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.

Detailed Description

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Conditions

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Osteoarthritis Hyperthyroidism Iodine Toxicity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Povidone Iodine Solution

The group whom PI solution will be used at surgery

Group Type ACTIVE_COMPARATOR

PI solution

Intervention Type PROCEDURE

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.

Saline Solution

The group whom only saline solution will be used at surgery

Group Type PLACEBO_COMPARATOR

Saline Solution

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type 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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ankara University

OTHER

Sponsor Role lead

Responsible Party

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Hakan KOCAOGLU

M.D. Assoc. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hakan Kocaoglu, MD

Role: PRINCIPAL_INVESTIGATOR

Ankara University

Locations

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Ankara University Faculty of Medicine

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Hakan Kocaoglu, MD

Role: CONTACT

00903125082321

Facility Contacts

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Hakan Kocaoglu, MD

Role: primary

00903125082321

Mehmet Batu Ertan, MD

Role: backup

00903542190010

References

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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.

Reference Type DERIVED
PMID: 39380015 (View on PubMed)

Other Identifiers

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Orthop2180

Identifier Type: -

Identifier Source: org_study_id

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