Natural Course of Homocysteine After Uneventful Total Joint Arthroplasty

• Sponsor: Bezmialem Vakif University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05990816
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 6.7

Study Details

Study Description

Brief 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 marker for periprosthetic joint infections ?

Condition or Disease	Intervention/Treatment	Phase
Joint Prosthesis; Complications, Infection or Inflammation	Diagnostic Test: Blood works for homocysteine levels

Study Design

• Study Type: Observational
• Anticipated Enrollment: 80 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Natural Course of Homocysteine After Uneventful Total Joint Arthroplasty
• Anticipated Study Start Date: Sep 10, 2023
• Anticipated Primary Completion Date: Sep 10, 2024
• Anticipated Study Completion Date: Sep 10, 2024

Arms and Interventions

Arm	Intervention/Treatment
Arthroplasty Patients Only one group that consist patients who underwent primary total joint arthroplasty	Diagnostic Test: Blood works for homocysteine levels; 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

Outcome Measures

Primary Outcome Measures

1. Homocysteine [6 months]

   Homocysteine levels in patient blood works

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bezmialem Vakif University	Istanbul		Turkey	34140

Sponsors and Collaborators

• Bezmialem Vakif University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

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.
• 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 Jul 19. doi: 10.1007/s00402-023-04989-6. Online ahead of print.

• Responsible Party: Cemil Burak DEMİRKIRAN, Resident Doctor, Bezmialem Vakif University
• ClinicalTrials.gov Identifier: NCT05990816
• Other Study ID Numbers: cbdemirkan
• First Posted: Aug 14, 2023
• Last Update Posted: Aug 14, 2023
• Last Verified: Aug 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Cemil Burak DEMİRKIRAN, Resident Doctor, Bezmialem Vakif University: periprosthetic joint infection; diagnosis; natural course; total joint arthroplasty.
• Additional relevant MeSH terms: Inflammation

Study Results

No Results Posted as of Aug 14, 2023