Synovitis in Patients With Osteoarthritis
Sponsor
The Affiliated Hospital of Qingdao University (Other)
Overall Status
Completed
CT.gov ID
NCT05617573
Collaborator
(none)
272
1
26
10.5
Study Details
Study Description
Brief Summary
To study synovial membrane (SM) inflammation in suprapatellar fossa in advanced knee osteoarthritis (OA), and to correlate the pathological features with clinical findings.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
272 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Correlations Between Microscopic Features of Synovium and Clinical Parameters in Patients With Advanced Osteoarthritis
Actual Study Start Date
:
Nov 1, 2020
Actual Primary Completion Date
:
Dec 31, 2022
Actual Study Completion Date
:
Dec 31, 2022
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients undergone TKA due to advanced knee osteoarthritis
|
Procedure: Total knee arthroplasty due to advanced osteoarthritis.
Postoperative usage of intravenous methylprednisolone
|
Outcome Measures
Primary Outcome Measures
- Correlation between pathological features and clinical scores [1 day.]
- Correlation between pathological features and laboratory index [1 day]
Eligibility Criteria
Criteria
Ages Eligible for Study:
55 Years
to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- patients undergoing elective, unilateral, primary TKA for advanced osteoarthritis.
Exclusion Criteria:
- revisions, bilateral procedures, alcohol or medical abuse, administration of any glucocorticoids during the 3 months prior to surgery, and/or a history of serious cardiac or cerebrovascular problems, severe liver or kidney failure, and/or connective tissue disease including rheumatoid arthritis, ankylosing spondylitis, and systemic lupus erythematosus.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The affiliated hospital of Qingdao University | Qingdao | Shandong | China | 266000 |
Sponsors and Collaborators
- The Affiliated Hospital of Qingdao University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Xiang Shuai, MD,
Principal Investigator,
The Affiliated Hospital of Qingdao University
ClinicalTrials.gov Identifier:
NCT05617573
Other Study ID Numbers:
- OASynoviumAHQD
First Posted:
Nov 15, 2022
Last Update Posted:
Jan 4, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms: