Arthritis KneeNCT05476367
Patients With Asymptomatic Hyperuricemia Have Stronger Local Inflammatory Response and Worse Outcome After Total Knee Arthroplasty
An observational study of Arthritis Knee, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Arthritis Knee
- How many people
- 614 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2022to 1 Sep 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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients received primary TKA(totla knee arthroplasty) in our hospital.
Who may be able to join
- patients who had undergone primary TKA from April 1, 2015, to March 30, 2016
Who cannot join
- (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.
About this study
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.
- Conditions
- Arthritis Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
CRP
C-reactive protein
Measured: within 7 days after surgery
temperature
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.
Measured: within 7 days after surgery
HSS score
the hospital for special surgery knee score
Measured: 6 years after surgery
KSS scores
knee society score
Measured: 6 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2022
- Study start1 Aug 2022 (estimated)
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arthritis KneeStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 614 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05476367
- Sponsor's protocol ID
- 2021-0785
- Status last verified
- Jul 2022
- First submitted
- 25 Jul 2022
- Last updated
- 27 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yu J, Mi T, Shao Z, Yan X. The Outcomes of Patients With Hyperuricemia After Total Knee Arthroplasty: A Retrospective Cohort Study. Orthop Surg. 2025 Dec;17(12):3477-3487. doi: 10.1111/os.70197. Epub 2025 Nov 6.
PubMed 41198532
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patients With Asymptomatic Hyperuricemia Have Stronger Local Inflammatory Response and Worse Outcome After Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT05476367
- Acronym / sponsor ID
- 2021-0785
- Conditions
- Arthritis Knee
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 614 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Aug 2022 (estimated)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 27 Jul 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.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients received primary TKA(totla knee arthroplasty) in our hospital.
Key inclusion criteria (1 listed)
- patients who had undergone primary TKA from April 1, 2015, to March 30, 2016
Key exclusion criteria (1 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
CRP
Time frame: within 7 days after surgery
C-reactive protein
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.
HSS score
Time frame: 6 years after surgery
the hospital for special surgery knee score
KSS scores
Time frame: 6 years after surgery
knee society score
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.
- Derived from this study: PubMed 41198532Yu J, Mi T, Shao Z, Yan X. The Outcomes of Patients With Hyperuricemia After Total Knee Arthroplasty: A Retrospective Cohort Study. Orthop Surg. 2025 Dec;17(12):3477-3487. doi: 10.1111/os.70197. Epub 2025 Nov 6.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis Knee, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
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: status not confirmed, as of the sponsor's last update on 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
CRP (time frame: within 7 days after surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05476367, which also lists 1 linked publication.
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 27 Jul 2022.