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Enthesitis in Patients With Knee Osteoarthritis

Sponsor
Al-Azhar University (Other)
Overall Status
Completed
CT.gov ID
NCT03897829
Collaborator
(none)
200
Enrollment
2
Locations
2
Actual Duration (Months)
100
Patients Per Site
49.1
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    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.

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

    2. 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

    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 :
    Mar 29, 2019
    Actual Primary Completion Date :
    May 1, 2019
    Actual Study Completion Date :
    May 30, 2019

    Outcome Measures

    Primary Outcome Measures

    1. Prevalence of knee cap enthesitis in patients with knee osteoarthritis [two months]

      Detection of the prevalence

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Al-Azhar Faculty of medicine, Rheumatology Department Cairo Egypt 11311
    2 Al-Azhar university hospitals Cairo Egypt 11311

    Sponsors and Collaborators

    • Al-Azhar University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ahmed Abogamal, Professor, Al-Azhar University
    ClinicalTrials.gov Identifier:
    NCT03897829
    Other Study ID Numbers:
    • aswu/320/1/19
    First Posted:
    Apr 1, 2019
    Last Update Posted:
    Jun 11, 2019
    Last Verified:
    Jun 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ahmed Abogamal, Professor, Al-Azhar University
    enthesitis
    osteoarthritis
    ultrasound
    Additional relevant MeSH terms:
    Osteoarthritis
    Osteoarthritis, Knee

    Study Results

    No Results Posted as of Jun 11, 2019