OsteoarthritisNCT05599841
Povidone Iodine Irrıgation at Hip-Knee Arthroplasty
A study testing PI solution and Saline Solution in people with Osteoarthritis and Hyperthyroidism, run by Ankara University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Hyperthyroidism, Iodine Toxicity
- What is being tested?
- PI solution and Saline Solution
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 16 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients with hip/knee osteoarthritis who undergo primary arthroplasty
Who cannot join
- Patients with abnormal thyroid function tests in the preoperative period, a history of the previous thyroid-related disease.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara University Faculty of Medicine
Ankara, 06100
Hakan Kocaoglu, MD, 00903125082321, kocaoglu@ankara.edu.tr
Mehmet Batu Ertan, MD, 00903542190010, mbatuertan@gmail.com
About this study
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
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.
- Conditions
- Osteoarthritis, Hyperthyroidism, Iodine Toxicity
- Being tested
- PI solution, Saline Solution
- Medical subject headings
- Osteoarthritis, Hyperthyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PI solutionProcedure or surgery
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 SolutionProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Povidone Iodine Solution | Active comparator | The group whom PI solution will be used at surgery Receives: Procedure: PI solution |
| Saline Solution | Placebo comparator | The group whom only saline solution will be used at surgery Receives: Procedure: Saline Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine iodine level
Urine iodine concentration
Measured: postoperative first day
Secondary outcomes (1)
Thyroid hormone
Blood thyroid hormone levels including: TSH, T3 and T4
Measured: postoperative 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2022
- Study start1 Jan 2019
- Primary completion31 May 2023
- Study completion16 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hakan KOCAOGLU, Ankara University
- Investigators
- Hakan Kocaoglu, MD, Principal investigator, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05599841
- Sponsor's protocol ID
- Orthop2180
- Status last verified
- Sep 2023
- First submitted
- 26 Oct 2022
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39380015
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05599841
- Acronym / sponsor ID
- Orthop2180
- Conditions
- Osteoarthritis, Hyperthyroidism, Iodine Toxicity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 16 Sep 2023 (estimated)
- First posted
- 31 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Povidone Iodine Solution | Active comparator | Procedure: PI solutionThe group whom PI solution will be used at surgery |
| Saline Solution | Placebo comparator | Procedure: Saline SolutionThe group whom only saline solution will be used at surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients with hip/knee osteoarthritis who undergo primary arthroplasty
Key exclusion criteria (1 listed)
- Patients with abnormal thyroid function tests in the preoperative period, a history of the previous thyroid-related disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PI solution3,000 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. | Procedure or surgery | Povidone Iodine Solution |
| Saline Solution3,000 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 | Procedure or surgery | Saline Solution |
Primary outcome
Urine iodine level
Time frame: postoperative first day
Urine iodine concentration
1 secondary outcome
Thyroid hormone
Time frame: postoperative 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Derived from this study: PubMed 39380015Ertan 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.
- Individual participant dataSharing planned: No
Related trials for Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hakan Kocaoglu, MD principal investigator
Ankara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PI solution and Saline Solution in people with Osteoarthritis and Hyperthyroidism, run by Ankara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hakan Kocaoglu, MD (00903125082321, kocaoglu@ankara.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urine iodine level (time frame: postoperative first day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05599841, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.