Synovitis in Patients With Osteoarthritis | NCT05617573

Studies
Synovitis in Patients With Osteoarthritis

NCT05617573

Sponsor

The Affiliated Hospital of Qingdao University

Status

Completed

Last Update Posted

Jan 4, 2023Actual

Enrollment

272Actual

Phase

Not provided

Conditions

Osteoarthritis, Knee

Interventions

Total knee arthroplasty due to advanced osteoarthritis.

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2020Actual

Primary Completion Date

Dec 31, 2022Actual

Completion Date

Dec 31, 2022Actual

First Submitted Date

Nov 8, 2022

First Submission Date that Met QC Criteria

Nov 8, 2022

First Posted Date

Nov 15, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 2, 2023

Last Update Posted Date

Jan 4, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Xiang Shuai, MD, Principal Investigator, The Affiliated Hospital of Qingdao UniversityPrincipal Investigator

Lead Sponsor

The Affiliated Hospital of Qingdao UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

272Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients undergone TKA due to advanced knee osteoarthritis			Procedure: Total knee arthroplasty due to advanced osteoarthritis.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Total knee arthroplasty due to advanced osteoarthritis.	Procedure	Postoperative usage of intravenous methylprednisolone	Patients undergone TKA due to advanced knee osteoarthritis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Correlation between pathological features and clinical scores		1 day.
Correlation between pathological features and laboratory index		1 day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with advanced knee osteoarthritis

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The affiliated hospital of Qingdao University		Qingdao	Shandong	266000	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020370	Osteoarthritis, Knee

Ancestor Terms

ID	Term
D010003	Osteoarthritis
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided