Clinical trial NCT03897829: Enthesitis in Patients With Knee Osteoarthritis
Official title: Prevalence of Knee Cap Enthesitis in Patients With Knee Osteoarthritis, Cross Sectional Ultrasonographic Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Keywords: enthesitis
osteoarthritis
ultrasound
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2019-04-01
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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.

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:

1. 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.
2. Inferior pole of the patella - proximal patellar ligament enthesis: ● Patellar ligament thickness \>4 mm ● Inferior pole of patella erosion ● Inferior pole of patella enthesophyte.
3. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Prevalence of knee cap enthesitis in patients with knee osteoarthritis
timeFrame: two months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Al-Azhar Faculty of medicine, Rheumatology Department
city: Cairo
country: Egypt
facility: Al-Azhar university hospitals
Study officials:
References: