NCT05617573

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
272

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2020

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

November 8, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 15, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

January 4, 2023

Status Verified

January 1, 2023

Enrollment Period

2.2 years

First QC Date

November 8, 2022

Last Update Submit

January 2, 2023

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (2)

  • Correlation between pathological features and clinical scores

    1 day.

  • Correlation between pathological features and laboratory index

    1 day

Study Arms (1)

Patients undergone TKA due to advanced knee osteoarthritis

Procedure: Total knee arthroplasty due to advanced osteoarthritis.

Interventions

Total knee arthroplasty due to advanced osteoarthritis.PROCEDURE

Postoperative usage of intravenous methylprednisolone

Patients undergone TKA due to advanced knee osteoarthritis

Eligibility Criteria

Age55 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with advanced knee osteoarthritis

You may qualify if:

  • patients undergoing elective, unilateral, primary TKA for advanced osteoarthritis.

You may not qualify if:

  • \- 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The affiliated hospital of Qingdao University

Qingdao, Shandong, 266000, China

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 8, 2022

First Posted

November 15, 2022

Study Start

November 1, 2020

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

January 4, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)