Knee osteoarthritis Injection Therapy (KNiT) trial - KNiT

Beacon Hospital0 sites135 target enrollmentFebruary 5, 2021

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Knee osteoarthritis (OA). Osteoarthritis (OA) is a debilitating disease which mostly affects people over 60 years of age. It is known to be within the top 10 contributors to years lived with disability worldwide1. The increasing number of patients with symptomatic OA in an ageing population will continue to place an increasingly larger economic burden on global healthcare systems. The knee is a common location for the disease, causing pain, stiffness and problems with sleep and daily activities.
Sponsor: Beacon Hospital
Enrollment: 135
Status: Active, Not Recruiting
Last Updated: 4 years ago

No summary available.

Registry

who.int

Start Date

February 5, 2021

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Beacon Hospital

•To be eligible for inclusion, each subject must meet each of the following criteria at Screening (Visit 1\) and must continue to fulfil these criteria at Baseline (Visit 2\):
•\-Age over 30 years
•\-Mean VAS pain score of \>40 of 100 (worst possible pain) over the course of 7 days during the previous month
•\-OA diagnosed by the American College of Rheumatology criteria
•\-Grade 1\-3 radiographic OA as defined by the Kellgren\-Lawrence classification
•\-Unilateral symptoms
•\-Patient is able to complete trial procedures and complete informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes

•\-Knee instability during physical examination (grade II or III)
•\-Pre\-treatment VAS pain score of \<40 of 100
•\-Major axial deviation (\>10 degrees of valgus or varus deviation)
•\-Bilateral symptomatic lesions
•\-Current use of anticoagulant medications or NSAIDs used in the 5 days before blood donation
•\-Recent intra\-articular injection of corticosteroids and prior treatment with HA or PRP in the past 6 months
•\-Symptomatic osteoarthritis in the contralateral knee
•\-Allergy/sensitivity to study medications or their ingredients
•\-Female subjects who are pregnant or breast\-feeding or considering becoming pregnant during the initial treatment period
•\-Subjects who have a history of drug or alcohol use that, in the opinion of the investigator, would interfere with adherence to study requirements