Knee OsteoarthritisNCT05955573
Knee Osteoarthritis, Aging and Metabolic Syndrome
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 Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- xray
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Aug 2023to Aug 2024
- How long will I take part?
- 1 Month
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: knee osteoartgritis
Who may be able to join
- Patients who met the American College of Rheumatology (ACR) clinical criteria for knee OA and had symptomatic OA of at least 1 knee (index knee), with a Kellgren / Lawrence (K/L) score ≥ 1 in that knee
Who cannot join
- Any patient with a history of trauma to the knee
- Any other form of arthritis (e.g., rheumatoid arthritis, seronegative spondyloarthropathies, gout, pyrophosphate disease, or other crystal arthropathy)
Trial locations and contacts
1 site in 1 country.
Hanan Sayed Abo-zaid, MD contact
About this study
Official title: What Affects the Severity of Knee Osteoarthritis? Aging or Associated Metabolic Syndrome
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
Read the detailed description
- Place of the study: Sohag university hospital.
- Type of study: Cross-Sectional Observational study
- Study period: Six months to one year The study will include Patients who met the American College of Rheumatology (ACR) clinical criteria for knee OA .
The following details will be obtained:
- Demographic data : Age ,Sex ,Marital status ,Occupation ,Residence ,Education level ,Anthropometrical measures which included waist circumference (WC) and blood pressure (BP) will be obtained,History of chronic diseases (eg; Diabetes mellites, Hypertension)
- Clinical information: Symptom and its Duration. Plain radiographs of at least one knee [anteroposterior (A/P), lateral} will be taken.
- Laboratory findings included fasting blood sugar, serum levels of triglycerides, High-density lipoprotein cholesterol and total cholesterol.
- Conditions
- Knee Osteoarthritis
- Being tested
- xray
- Keywords
- knee osteoarthritis, Aging, Metabolic Syndrome
- Medical subject headings
- Osteoarthritis, Knee, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
xrayDiagnostic test
radiological description
| Study group | Role | What they receive |
|---|---|---|
| knee osteoarthritis | Knee osteoarthritis Receives: Diagnostic Test: xray |
What is being measured
The primary outcome is the main question the study is designed to answer.
severity of knee osteoarthritis
Kellgren and Lawrence (K/L) grading system of Knee osteoarthritis. It assigned a grade from 0 to 4, which they correlated to increasing severity of OA, with Grade 0 signifying no presence of OA and Grade 4 signifying severe OA .
Measured: 8/2023-8/2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2023
- Study start20 Aug 2023
- Primary completionJun 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 only
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amany Mohamed Abdelrahman, Sohag University
- Investigators
- Dalia Shaker Elgendy, MD, Study chair, Sohag UniversityHanan Sayed Abo-zaid, MD, Study director, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05955573
- Sponsor's protocol ID
- Soh-Med-23-07-17MS
- Status last verified
- Mar 2024
- First submitted
- 13 Jul 2023
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Grundy SM, Cleeman JI, Daniels SR, Donato KA, Eckel RH, Franklin BA, Gordon DJ, Krauss RM, Savage PJ, Smith SC Jr, Spertus JA, Costa F; American Heart Association; National Heart, Lung, and Blood Institute. Diagnosis and management of the metabolic syndrome: an American Heart Association/National Heart, Lung, and Blood Institute Scientific Statement. Circulation. 2005 Oct 25;112(17):2735-52. doi: 10.1161/CIRCULATIONAHA.105.169404. Epub 2005 Sep 12. No abstract available.
PubMed 16157765Krasnokutsky 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 28217895
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What Affects the Severity of Knee Osteoarthritis? Aging or Associated Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT05955573
- Acronym / sponsor ID
- Soh-Med-23-07-17MS
- Conditions
- Knee Osteoarthritis
- Keywords
- knee osteoarthritis, Aging, Metabolic Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 20 Aug 2023 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 21 Jul 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
Detailed description
- Place of the study: Sohag university hospital.
- Type of study: Cross-Sectional Observational study
- Study period: Six months to one year The study will include Patients who met the American College of Rheumatology (ACR) clinical criteria for knee OA .
The following details will be obtained:
- Demographic data : Age ,Sex ,Marital status ,Occupation ,Residence ,Education level ,Anthropometrical measures which included waist circumference (WC) and blood pressure (BP) will be obtained,History of chronic diseases (eg; Diabetes mellites, Hypertension)
- Clinical information: Symptom and its Duration. Plain radiographs of at least one knee [anteroposterior (A/P), lateral} will be taken.
- Laboratory findings included fasting blood sugar, serum levels of triglycerides, High-density lipoprotein cholesterol and total cholesterol.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| knee osteoarthritis | – | Diagnostic Test: xrayKnee osteoarthritis |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- knee osteoartgritis
Key inclusion criteria (1 listed)
- Patients who met the American College of Rheumatology (ACR) clinical criteria for knee OA and had symptomatic OA of at least 1 knee (index knee), with a Kellgren / Lawrence (K/L) score ≥ 1 in that knee
Key exclusion criteria (2 listed)
- Any patient with a history of trauma to the knee
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 |
|---|---|---|
| xrayradiological description | Diagnostic test | knee osteoarthritis |
Primary outcome
severity of knee osteoarthritis
Time frame: 8/2023-8/2024
Kellgren and Lawrence (K/L) grading system of Knee osteoarthritis. It assigned a grade from 0 to 4, which they correlated to increasing severity of OA, with Grade 0 signifying no presence of OA and Grade 4 signifying severe OA .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Background: PubMed 16157765Grundy SM, Cleeman JI, Daniels SR, Donato KA, Eckel RH, Franklin BA, Gordon DJ, Krauss RM, Savage PJ, Smith SC Jr, Spertus JA, Costa F; American Heart Association; National Heart, Lung, and Blood Institute. Diagnosis and management of the metabolic syndrome: an American Heart Association/National Heart, Lung, and Blood Institute Scientific Statement. Circulation. 2005 Oct 25;112(17):2735-52. doi: 10.1161/CIRCULATIONAHA.105.169404. Epub 2005 Sep 12. No abstract available.
- 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.
- Related InfoLink provided by the sponsor.
- 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.
Hanan Sayed Abo-zaid, MD contact
Dalia Shaker Elgendy, MD study chair
Sohag University
Hanan Sayed Abo-zaid, MD study director
Sohag University
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 2 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 19 Mar 2024. 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 Amany Mohamed abdelrahman, master (01066706352, amanymohamed@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
severity of knee osteoarthritis (time frame: 8/2023-8/2024). 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 NCT05955573, which also lists 2 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 19 Mar 2024.