Joint Prosthesis; Complications, Infection or InflammationNCT05990816
Natural Course of Homocysteine After Uneventful Total Joint Arthroplasty
An observational study of Joint Prosthesis; Complications, Infection or Inflammation, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Joint Prosthesis; Complications, Infection or Inflammation
- What is being tested?
- Blood works for homocysteine levels
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Apr 2024to 10 Sep 2025
- Phase
- Observational
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healty volunteers who have undergone uneventful primary total joint arthroplasty
Who may be able to join
- People who have undergone Total Knee Arthroplasty operation
- People who have undergone Total Hip Arthroplasty operation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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 ?
- Being tested
- Blood works for homocysteine levels
- Keywords
- periprosthetic joint infection, diagnosis, natural course, total joint arthroplasty.
- Medical subject headings
- Infections, Inflammation, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood works for homocysteine levelsDiagnostic test
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
| Study group | Role | What they receive |
|---|---|---|
| Arthroplasty Patients | Only one group that consist patients who underwent primary total joint arthroplasty Receives: Diagnostic Test: Blood works for homocysteine levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
Homocysteine
Homocysteine levels in patient blood works
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start10 Apr 2024 (estimated)
- Primary completion10 Sep 2025 (estimated)
- Study completion10 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Joint Prosthesis; Complications, Infection or InflammationStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cemil Burak DEMİRKIRAN, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05990816
- Sponsor's protocol ID
- cbdemirkan
- Status last verified
- Feb 2024
- First submitted
- 5 Aug 2023
- Last updated
- 12 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 20981167Watanabe 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.
PubMed 37468711Azboy 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.
PubMed 34088567
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural Course of Homocysteine After Uneventful Total Joint Arthroplasty
- ClinicalTrials.gov ID
- NCT05990816
- Acronym / sponsor ID
- cbdemirkan
- Keywords
- periprosthetic joint infection, diagnosis, natural course, total joint arthroplasty.
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 10 Apr 2024 (estimated)
- Primary completion
- 10 Sep 2025 (estimated)
- Study completion
- 10 Sep 2025 (estimated)
- First posted
- 14 Aug 2023 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arthroplasty Patients | – | Diagnostic Test: Blood works for homocysteine levelsOnly one group that consist patients who underwent primary total joint arthroplasty |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healty volunteers who have undergone uneventful primary total joint arthroplasty
Key inclusion criteria (2 listed)
- People who have undergone Total Knee Arthroplasty operation
- People who have undergone Total Hip Arthroplasty operation
Key exclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| Blood works for homocysteine levelsIn 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 | Diagnostic test | Arthroplasty Patients |
Primary outcome
Homocysteine
Time frame: 6 months
Homocysteine levels in patient blood works
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
- Background: PubMed 20981167Mouravas 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.
- Background: PubMed 37468711Watanabe 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.
- Results publication: PubMed 34088567Azboy 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.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Joint Prosthesis; Complications, Infection or Inflammation, run by Bezmialem Vakif 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 2 inclusion and 2 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 12 Feb 2024. 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. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Homocysteine (time frame: 6 months). 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 NCT05990816, which also lists 3 linked publications.
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 12 Feb 2024.