Knee OsteoarthritisNCT06149078
The Relationship of Serum Uric Acid With Severity of Knee Osteoarthritis
An observational study of Knee Osteoarthritis, run by Sohag University at 1 site in Egypt.
Trial summary
Osteoarthritis (OA) is the most prevalent form of arthritis. Its pathogenesis remains poorly understood. Though historically regarded as a disease of mechanical degeneration, it is now appreciated that inflammation plays an important role in OA pathogenesis (Krasnokutsky et al., 2017). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- serum uric acid
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Dec 2023to 10 May 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: - Adult patient (Age>18 years) with a complaint of knee pain.
Who may be able to join
- Adult patient (Age>18 years) with a complaint of knee pain.
Who cannot join
- 1.Any patient with a history of trauma to the knee. 2 Any patient with knee complaints as a part of autoimmune connective tissue disease.
Trial locations and contacts
1 site in 1 country.
Abdullah M Ahmed, assistant professor contact
About this study
Osteoarthritis (OA) is the most prevalent form of arthritis. Its pathogenesis remains poorly understood. Though historically regarded as a disease of mechanical degeneration, it is now appreciated that inflammation plays an important role in OA pathogenesis (Krasnokutsky et al., 2017). The hallmark of OA is the degradation and loss of articular cartilage, although most tissues of the joint become affected, such as bone, synovium, ligaments, menisci (knee), labrum (hip), periarticular fat, and muscle (Englund, 2023).It is believed that there is a pathological link between hyperuricemia and OA Therefore, we conducted a cross-sectional study to evaluate an association between elevated SUA and radiographic OA of the knee) Bipan Shrestha, 2019 (.
- Conditions
- Knee Osteoarthritis
- Being tested
- serum uric acid
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum uric acidDiagnostic test
to detect the relaton ship of serum uric acid with sevwrity of knee osteoarthritis
| Study group | Role | What they receive |
|---|---|---|
| cases group | hyperurecemic Receives: Diagnostic Test: serum uric acid | |
| control group | normal Receives: Diagnostic Test: serum uric acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of serum uric acid
detect the relationship of serum uric acid with severity of knee osteoarthritis
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2023
- Study start10 Dec 2023 (estimated)
- Primary completion10 May 2024 (estimated)
- Study completion10 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe 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
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Mohamed Saber, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06149078
- Sponsor's protocol ID
- Soh-Med-23-11-10MS
- Status last verified
- Nov 2023
- First submitted
- 20 Nov 2023
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Englund M. Osteoarthritis, part of life or a curable disease? A bird's-eye view. J Intern Med. 2023 Jun;293(6):681-693. doi: 10.1111/joim.13634. Epub 2023 Apr 2.
PubMed 37004213Krasnokutsky S, Oshinsky C, Attur M, Ma S, Zhou H, Zheng F, Chen M, Patel J, Samuels J, Pike VC, Regatte R, Bencardino J, Rybak L, Abramson S, Pillinger MH. Serum Urate Levels Predict Joint Space Narrowing in Non-Gout Patients With Medial Knee Osteoarthritis. Arthritis Rheumatol. 2017 Jun;69(6):1213-1220. doi: 10.1002/art.40069. Epub 2017 Apr 28.
PubMed 28217895Park D, Park YM, Ko SH, Hyun KS, Choi YH, Min DU, Han K, Koh HS. Association of general and central obesity, and their changes with risk of knee osteoarthritis: a nationwide population-based cohort study. Sci Rep. 2023 Mar 7;13(1):3796. doi: 10.1038/s41598-023-30727-4.
PubMed 36882508
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship of Serum Uric Acid With Severity of Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06149078
- Acronym / sponsor ID
- Soh-Med-23-11-10MS
- Conditions
- Knee Osteoarthritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 10 Dec 2023 (estimated)
- Primary completion
- 10 May 2024 (estimated)
- Study completion
- 10 May 2024 (estimated)
- First posted
- 28 Nov 2023 (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.
Osteoarthritis (OA) is the most prevalent form of arthritis. Its pathogenesis remains poorly understood. Though historically regarded as a disease of mechanical degeneration, it is now appreciated that inflammation plays an important role in OA pathogenesis (Krasnokutsky et al., 2017). The hallmark of OA is the degradation and loss of articular cartilage, although most tissues of the joint become affected, such as bone, synovium, ligaments, menisci (knee), labrum (hip), periarticular fat, and muscle (Englund, 2023).It is believed that there is a pathological link between hyperuricemia and OA Therefore, we conducted a cross-sectional study to evaluate an association between elevated SUA and radiographic OA of the knee) Bipan Shrestha, 2019 (.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cases group | – | Diagnostic Test: serum uric acidhyperurecemic |
| control group | – | Diagnostic Test: serum uric acidnormal |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- - Adult patient (Age>18 years) with a complaint of knee pain.
Key inclusion criteria (1 listed)
- Adult patient (Age>18 years) with a complaint of knee pain.
Key exclusion criteria (1 listed)
- 1.Any patient with a history of trauma to the knee. 2 Any patient with knee complaints as a part of autoimmune connective tissue disease.
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 |
|---|---|---|
| serum uric acidto detect the relaton ship of serum uric acid with sevwrity of knee osteoarthritis | Diagnostic test | cases group, control group |
Primary outcome
percentage of serum uric acid
Time frame: 6 months
detect the relationship of serum uric acid with severity of knee osteoarthritis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Background: PubMed 37004213Englund M. Osteoarthritis, part of life or a curable disease? A bird's-eye view. J Intern Med. 2023 Jun;293(6):681-693. doi: 10.1111/joim.13634. Epub 2023 Apr 2.
- Background: PubMed 28217895Krasnokutsky S, Oshinsky C, Attur M, Ma S, Zhou H, Zheng F, Chen M, Patel J, Samuels J, Pike VC, Regatte R, Bencardino J, Rybak L, Abramson S, Pillinger MH. Serum Urate Levels Predict Joint Space Narrowing in Non-Gout Patients With Medial Knee Osteoarthritis. Arthritis Rheumatol. 2017 Jun;69(6):1213-1220. doi: 10.1002/art.40069. Epub 2017 Apr 28.
- Background: PubMed 36882508Park D, Park YM, Ko SH, Hyun KS, Choi YH, Min DU, Han K, Koh HS. Association of general and central obesity, and their changes with risk of knee osteoarthritis: a nationwide population-based cohort study. Sci Rep. 2023 Mar 7;13(1):3796. doi: 10.1038/s41598-023-30727-4.
- Individual participant dataSharing planned: Undecided
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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.
Abdullah M Ahmed, assistant professor contact
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 Knee Osteoarthritis, run by Sohag University at 1 site in Egypt.
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 28 Nov 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aya M Saber, resident (01278825940, ayamohamed@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of serum uric acid (time frame: 6 months). 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 NCT06149078, which also lists 3 linked publications.
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 28 Nov 2023.