NCT03897829

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2019

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

March 29, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 1, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2019

Completed
Last Updated

June 11, 2019

Status Verified

June 1, 2019

Enrollment Period

1 month

First QC Date

March 29, 2019

Last Update Submit

June 10, 2019

Conditions

Osteoarthritis

Keywords

enthesitisosteoarthritisultrasound

Outcome Measures

Primary Outcomes (1)

  • Prevalence of knee cap enthesitis in patients with knee osteoarthritis

    Detection of the prevalence

    two months

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Al-Azhar Faculty of medicine, Rheumatology Department

Cairo, 11311, Egypt

Location

Al-Azhar university hospitals

Cairo, 11311, Egypt

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 29, 2019

First Posted

April 1, 2019

Study Start

March 29, 2019

Primary Completion

May 1, 2019

Study Completion

May 30, 2019

Last Updated

June 11, 2019

Record last verified: 2019-06

Locations

EG(2)