OsteoarthritisNCT03897829
Enthesitis in Patients With Knee Osteoarthritis
An observational study of Osteoarthritis, run by Al-Azhar University at 2 sites in Egypt.
Trial summary
The current study was conducted to estimate the prevalence of knee cap enthesitis in patients with knee osteoarthritis and its relation to knee function. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis
- How many people
- 200 participants
- Where
- 2 sitesEgypt
- Study dates
- 29 Mar 2019to 30 May 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The current study will be based on a cross-sectional hospital-based survey, conducted among patients with knee osteoarthritis presenting at outpatient rheumatology clinics of AL-AZHAR University Hospitals, and Aswan university hospital according to the inclusion-exclusion criteria.
Who may be able to join
- Primary Knee OA diagnosed according to: American College of Rheumatology Radiologic Criteria for Knee Osteoarthritis.
- Kellegren - Lawrance scale grade II.
- On regular treatment by analgesics, or NSAIDS either topical or systemic.
Who cannot join
- Recent Knee trauma or intra-articular procedures.
- Previous knee surgery.
- Inflammatory joint diseases, as rheumatoid arthritis, crystal arthritis, and spondyloarthropathy
- chronic systemic diseases that could affect patient functional ability; e.g renal, liver, cardiac impairment, or neurological disorder.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Al-Azhar Faculty of medicine, Rheumatology Department
Cairo, 11311
Al-Azhar university hospitals
Cairo, 11311
About this study
Official title: Prevalence of Knee Cap Enthesitis in Patients With Knee Osteoarthritis, Cross Sectional Ultrasonographic Study.
The current study was conducted to estimate the prevalence of knee cap enthesitis in patients with knee osteoarthritis and its relation to knee function.
Read the detailed description
The current study will based on a cross sectional hospital-based survey, conducted among patients with knee osteoarthritis , Knee will assessed for the following items in both sides while Patient lying supine with the knee flexed 40 degrees:
- Superior pole of the patella - quadriceps tendon enthesis: ● Quadriceps tendon thickness >6.1 mm ● Suprapatellar bursitis ● Superior pole of patella erosion ● Superior pole of patella enthesophyte.
- Inferior pole of the patella - proximal patellar ligament enthesis: ● Patellar ligament thickness >4 mm ● Inferior pole of patella erosion ● Inferior pole of patella enthesophyte.
- Tibial tuberosity - distal patellar ligament enthesis ● Patellar ligament thickness >4 mm ● Infrapatellar bursitis ● Tibial tuberosity erosion ● Tibial tuberosity enthesophyte.
Knee functional status was assessed using Knee injury and Osteoarthritis Outcome Score (KOOS) scale for Pain, other Symptoms, Activities of Daily Living (ADL), Sport and Recreation Function (Sport/Rec) and knee-related Quality of Life (QOL). Low knee function was considered if the patient had score 50 or more in any KOOS scale parameter.
- Conditions
- Osteoarthritis
- Keywords
- enthesitis, osteoarthritis, ultrasound
- Medical subject headings
- Osteoarthritis
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of knee cap enthesitis in patients with knee osteoarthritis
Detection of the prevalence
Measured: two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2019
- Study start29 Mar 2019
- Primary completion1 May 2019
- Study completion30 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abogamal, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03897829
- Sponsor's protocol ID
- aswu/320/1/19
- Status last verified
- Jun 2019
- First submitted
- 29 Mar 2019
- Last updated
- 11 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: not yet decided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Knee Cap Enthesitis in Patients With Knee Osteoarthritis, Cross Sectional Ultrasonographic Study.
- ClinicalTrials.gov ID
- NCT03897829
- Acronym / sponsor ID
- aswu/320/1/19
- Conditions
- Osteoarthritis
- Keywords
- enthesitis, osteoarthritis, ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 29 Mar 2019 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 30 May 2019 (actual)
- First posted
- 1 Apr 2019 (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.
The current study was conducted to estimate the prevalence of knee cap enthesitis in patients with knee osteoarthritis and its relation to knee function.
Detailed description
The current study will based on a cross sectional hospital-based survey, conducted among patients with knee osteoarthritis , Knee will assessed for the following items in both sides while Patient lying supine with the knee flexed 40 degrees:
- Superior pole of the patella - quadriceps tendon enthesis: ● Quadriceps tendon thickness >6.1 mm ● Suprapatellar bursitis ● Superior pole of patella erosion ● Superior pole of patella enthesophyte.
- Inferior pole of the patella - proximal patellar ligament enthesis: ● Patellar ligament thickness >4 mm ● Inferior pole of patella erosion ● Inferior pole of patella enthesophyte.
- Tibial tuberosity - distal patellar ligament enthesis ● Patellar ligament thickness >4 mm ● Infrapatellar bursitis ● Tibial tuberosity erosion ● Tibial tuberosity enthesophyte.
Knee functional status was assessed using Knee injury and Osteoarthritis Outcome Score (KOOS) scale for Pain, other Symptoms, Activities of Daily Living (ADL), Sport and Recreation Function (Sport/Rec) and knee-related Quality of Life (QOL). Low knee function was considered if the patient had score 50 or more in any KOOS scale parameter.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The current study will be based on a cross-sectional hospital-based survey, conducted among patients with knee osteoarthritis presenting at outpatient rheumatology clinics of AL-AZHAR University Hospitals, and Aswan university hospital according to the inclusion-exclusion criteria.
Key inclusion criteria (3 listed)
- Primary Knee OA diagnosed according to: American College of Rheumatology Radiologic Criteria for Knee Osteoarthritis.
- Kellegren - Lawrance scale grade II.
- On regular treatment by analgesics, or NSAIDS either topical or systemic.
Key exclusion criteria (4 listed)
- Recent Knee trauma or intra-articular procedures.
- Previous knee surgery.
- Inflammatory joint diseases, as rheumatoid arthritis, crystal arthritis, and spondyloarthropathy
- chronic systemic diseases that could affect patient functional ability; e.g renal, liver, cardiac impairment, or neurological disorder.
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
Prevalence of knee cap enthesitis in patients with knee osteoarthritis
Time frame: two months
Detection of the prevalence
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2019.
- Individual participant dataSharing planned: Undecided. not yet decided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, run by Al-Azhar University at 2 sites 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 11 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Prevalence of knee cap enthesitis in patients with knee osteoarthritis (time frame: two months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jun 2019.