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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03897829
Other study ID # aswu/320/1/19
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 29, 2019
Est. completion date May 30, 2019

Study information

Verified date June 2019
Source Al-Azhar University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date May 30, 2019
Est. primary completion date May 1, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Egypt Al-Azhar Faculty of medicine, Rheumatology Department Cairo
Egypt Al-Azhar university hospitals Cairo

Sponsors (1)

Lead Sponsor Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Prevalence of knee cap enthesitis in patients with knee osteoarthritis Detection of the prevalence two months
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