Patients With Asymptomatic Hyperuricemia Have Stronger Local Inflammatory Response and Worse Outcome After Total Knee Arthroplasty

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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