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Enthesitis in Patients With Knee Osteoarthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03897829
Recruitment Status : Completed
First Posted : April 1, 2019
Last Update Posted : June 11, 2019
Information provided by (Responsible Party):
Ahmed Abogamal, Al-Azhar University

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.

Condition or disease

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.

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Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Prevalence of Knee Cap Enthesitis in Patients With Knee Osteoarthritis, Cross Sectional Ultrasonographic Study.
Actual Study Start Date : March 29, 2019
Actual Primary Completion Date : May 1, 2019
Actual Study Completion Date : May 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Primary Outcome Measures :
  1. Prevalence of knee cap enthesitis in patients with knee osteoarthritis [ Time Frame: two months ]
    Detection of the prevalence

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   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:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03897829

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Al-Azhar Faculty of medicine, Rheumatology Department
Cairo, Egypt, 11311
Al-Azhar university hospitals
Cairo, Egypt, 11311
Sponsors and Collaborators
Al-Azhar University

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Responsible Party: Ahmed Abogamal, Professor, Al-Azhar University Identifier: NCT03897829     History of Changes
Other Study ID Numbers: aswu/320/1/19
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: June 11, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: not yet decided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ahmed Abogamal, Al-Azhar University:
Additional relevant MeSH terms:
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Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases