- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05990816
Natural Course of Homocysteine After Uneventful Total Joint Arthroplasty
February 9, 2024 updated by: Cemil Burak DEMİRKIRAN, Bezmialem Vakif University
The goal of this observational study is to asses the natural course of blood homocysteine levels in patients who underwent primary total joint arthroplasty surgery. The main question[s] it aims to answer are:
- İs homocysteine a good marker for determining periprosthetic joint infection ?
- İs homocysteine more sensitive marker for periprosthetic joint infections ?
Study Overview
Status
Not yet recruiting
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Istanbul, Turkey, 34140
- Bezmialem Vakif University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
Healty volunteers who have undergone uneventful primary total joint arthroplasty
Description
Inclusion Criteria:
- People who have undergone Total Knee Arthroplasty operation
- People who have undergone Total Hip Arthroplasty operation
Exclusion Criteria:
- People who have undergone total knee arthroplasty operation and developed a periprosthetic joint infection
- People who have undergone total hip arthroplasty operation and developed a periprosthetic joint infection
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Arthroplasty Patients
Only one group that consist patients who underwent primary total joint arthroplasty
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In a single patient group of 80 people, the natural course of homocysteine after total joint arthroplasty will be examined by blood work analyzes at the 1,2,3,4 and 6th weeks after operation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Homocysteine
Time Frame: 6 months
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Homocysteine levels in patient blood works
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6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Mouravas H, Verettas D, Kazakos K, Xarhas K, Panagiotou N, Ellinas P. Homocysteine and its relationship to deep venous thrombosis in patients undergoing total knee or hip arthroplasty. Hippokratia. 2010 Jul;14(3):185-8.
- Azboy I, Catal B, Basarir K, Mutlu M, Bilgen OF, Parvizi J. The Natural Course of Serum D-Dimer, C-Reactive Protein, and Erythrocyte Sedimentation Rate Levels After Uneventful Primary Total Joint Arthroplasty. J Arthroplasty. 2021 Sep;36(9):3118-3122. doi: 10.1016/j.arth.2021.04.031. Epub 2021 Apr 30.
- Watanabe N, Ogawa T, Takada R, Amano Y, Jinno T, Koga H, Yoshii T, Okawa A, Miyatake K. Association of osteoporosis and high serum homocysteine levels with intraoperative periprosthetic fracture during total hip arthroplasty: a propensity-score matching analysis. Arch Orthop Trauma Surg. 2023 Dec;143(12):7219-7227. doi: 10.1007/s00402-023-04989-6. Epub 2023 Jul 19.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
April 10, 2024
Primary Completion (Estimated)
September 10, 2025
Study Completion (Estimated)
September 10, 2025
Study Registration Dates
First Submitted
August 5, 2023
First Submitted That Met QC Criteria
August 5, 2023
First Posted (Actual)
August 14, 2023
Study Record Updates
Last Update Posted (Actual)
February 12, 2024
Last Update Submitted That Met QC Criteria
February 9, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- cbdemirkan
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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