Osteoarthritis, KneeNCT05617573
Synovitis in Patients With Osteoarthritis
An observational study of Osteoarthritis, Knee, run by The Affiliated Hospital of Qingdao University at 1 site in China.
Trial summary
To study synovial membrane (SM) inflammation in suprapatellar fossa in advanced knee osteoarthritis (OA), and to correlate the pathological features with clinical findings. Read more about this study
- Who is it for?
- Ages 55 to 75 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Total knee arthroplasty due to advanced osteoarthritis.
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 272 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2020to 31 Dec 2022
- 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 55 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with advanced knee osteoarthritis
Who may be able to join
- patients undergoing elective, unilateral, primary TKA for advanced osteoarthritis.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The affiliated hospital of Qingdao University
Qingdao, Shandong, 266000
About this study
Official title: Correlations Between Microscopic Features of Synovium and Clinical Parameters in Patients With Advanced Osteoarthritis
To study synovial membrane (SM) inflammation in suprapatellar fossa in advanced knee osteoarthritis (OA), and to correlate the pathological features with clinical findings.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Total knee arthroplasty due to advanced osteoarthritis.
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total knee arthroplasty due to advanced osteoarthritis.Procedure or surgery
Postoperative usage of intravenous methylprednisolone
| Study group | Role | What they receive |
|---|---|---|
| Patients undergone TKA due to advanced knee osteoarthritis | Not described Receives: Procedure: Total knee arthroplasty due to advanced osteoarthritis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between pathological features and clinical scores
Measured: 1 day.
Correlation between pathological features and laboratory index
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2022
- Study start1 Nov 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- 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
- 272 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiang Shuai, MD, The Affiliated Hospital of Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05617573
- Sponsor's protocol ID
- OASynoviumAHQD
- Status last verified
- Jan 2023
- First submitted
- 8 Nov 2022
- Last updated
- 4 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlations Between Microscopic Features of Synovium and Clinical Parameters in Patients With Advanced Osteoarthritis
- ClinicalTrials.gov ID
- NCT05617573
- Acronym / sponsor ID
- OASynoviumAHQD
- Conditions
- Osteoarthritis, Knee
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 272 participants (actual)
- Lead sponsor
- The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 15 Nov 2022 (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.
To study synovial membrane (SM) inflammation in suprapatellar fossa in advanced knee osteoarthritis (OA), and to correlate the pathological features with clinical findings.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergone TKA due to advanced knee osteoarthritis | – | Procedure: Total knee arthroplasty due to advanced osteoarthritis. |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with advanced knee osteoarthritis
Key inclusion criteria (1 listed)
- patients undergoing elective, unilateral, primary TKA for advanced osteoarthritis.
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| Total knee arthroplasty due to advanced osteoarthritis.Postoperative usage of intravenous methylprednisolone | Procedure or surgery | Patients undergone TKA due to advanced knee osteoarthritis |
Primary outcome
Correlation between pathological features and clinical scores
Time frame: 1 day.
Correlation between pathological features and laboratory index
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2023.
- Individual participant dataSharing planned: No
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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 Osteoarthritis, Knee, run by The Affiliated Hospital of Qingdao University at 1 site in China.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 4 Jan 2023. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Correlation between pathological features and clinical scores (time frame: 1 day.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jan 2023; AzTrials last refreshed its copy on 31 Oct 2026.