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CompletedNCT03897829Updated Jun 11, 2019

Enthesitis in Patients With Knee Osteoarthritis

An observational study in Osteoarthritis, sponsored by Al-Azhar University. Completed at 2 sites in Egypt. Per ClinicalTrials.gov, last updated 2019-06-11.

Sponsored by Al-Azhar University · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
200
Sex
All
01

Study 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 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:

  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.

02

Conditions studied

  • Osteoarthritis

Keywords

  • enthesitis
  • osteoarthritis
  • ultrasound
03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's enrollment of 200 is above the median of 100 across 791 observational studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

Al-Azhar University is the lead sponsor of 505 studies on the registry; 167 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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.
05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
200 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Prevalence of knee cap enthesitis in patients with knee osteoarthritis

    Detection of the prevalence

    Time frame: two months

07

Study locations

2 sites
  • Al-Azhar Faculty of medicine, Rheumatology Department
    Cairo, 11311, Egypt
  • Al-Azhar university hospitals
    Cairo, 11311, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided — not yet decided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 11, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03897829
Lead sponsor
Al-Azhar University
Responsible party
Ahmed Abogamal (Professor, Al-Azhar University) — Principal investigator
First posted
Apr 1, 2019
Start date
Mar 29, 2019
Primary completion
May 1, 2019
Completion
May 30, 2019
Last update
Jun 11, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

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