- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05476367
Patients With Asymptomatic Hyperuricemia Have Stronger Local Inflammatory Response and Worse Outcome After Total Knee Arthroplasty
July 25, 2022 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University
We identify all patients who had undergone primary total knee arthroplsty(TKA) from April 1, 2015, to March 30, 2016.
Patients are grouped by uric acid level.
The knee society score(KSS score) and the hospital for special surgery knee score (HSS score) before the surgery and 6 years after the surgery will be collected.
Also the clinical data will be collected.
Study Overview
Status
Not yet recruiting
Conditions
Study Type
Observational
Enrollment (Anticipated)
614
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 83 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
All patients received primary TKA(totla knee arthroplasty) in our hospital.
Description
Inclusion Criteria:
- patients who had undergone primary TKA from April 1, 2015, to March 30, 2016
Exclusion Criteria:
- (1) infection, (2) rheumatoid arthritis, (3) ankylosing spondylitis, (4) revision surgery, (5) patients with unicondylar knee replacement, (6) patients who have been diagnosed with gout or previous gouty symptoms, and (7) patients combined with preoperative redness or swelling.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
---|
patients with normal uric acid level
The uric acid level is below 420 μmol/L in men and 360 μmol/L in women
|
patients with high uric acid level
The uric acid level is higher than 420 μmol/L in men and 360 μmol/L in women.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CRP
Time Frame: within 7 days after surgery
|
C-reactive protein
|
within 7 days after surgery
|
temperature
Time Frame: within 7 days after surgery
|
The nurses measured the body temperature by Non-contact Ear Thermometer.
The temperatures were measured at 6 am, 14 pm, and 18 pm every day, and the patients were kept admitted till day 5.
The highest one was chosen for analysis.
|
within 7 days after surgery
|
HSS score
Time Frame: 6 years after surgery
|
the hospital for special surgery knee score
|
6 years after surgery
|
KSS scores
Time Frame: 6 years after surgery
|
knee society score
|
6 years after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
August 1, 2022
Primary Completion (Anticipated)
September 1, 2022
Study Completion (Anticipated)
September 1, 2022
Study Registration Dates
First Submitted
July 25, 2022
First Submitted That Met QC Criteria
July 25, 2022
First Posted (Actual)
July 27, 2022
Study Record Updates
Last Update Posted (Actual)
July 27, 2022
Last Update Submitted That Met QC Criteria
July 25, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-0785
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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