Trial comparing three commercially available injection therapies for treatment of knee osteoarthritis
- 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.Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2021-000180-70-IE
- Lead Sponsor
- Beacon Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 135
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
F.1.2.1 Number of subjects for this age range 135
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
-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
-Known history of, or documented positive hepatitis B or C or HIV infection
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method