The Effect of Intra-articular Bilateral Knee Injections of Zilretta on Performance Measures in Ad… (NCT03895840) | Clinical Trial Compass
CompletedPhase 4
The Effect of Intra-articular Bilateral Knee Injections of Zilretta on Performance Measures in Adults With Knee OA
United States70 participantsStarted 2018-03-19
Plain-language summary
This study will be an open-label trial to determine the functional effects of bilateral IA injections of Zilretta into knee joints of 70 subjects with bilateral KL grade 2-4 symptomatic knee osteoarthritis (OA). Measurement and evaluation of outcomes at baseline, 6, 12 and 24 weeks will allow assessment of short and long-term effects, consistent with Osteoarthritis Research Society International (OARSI) and Outcome Measures in Rheumatology (OMERACT) recommendations.
Who can participate
Age range30 Years
SexALL
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Inclusion Criteria:
* Men and women age 30 years or older with symptomatic bilateral knee OA
* Symptomatic knee OA will be defined as the presence of a definite osteophyte or joint space narrowing (KL Grade ≥2) on posteroanterior (PA) fixed flexion knee radiographs in subjects limited by bilateral pain rated on a Numerical Rating Scale as ≥ 4/10 on more than half of the days over the past month. Radiographic change must be visible at standard image size, irrespective of capability to detect more subtle changes through digital enhancement.
* Bilateral knee symptoms for ≥ 3 months prior to screening
* Has undergone at least one prior conservative osteoarthritis treatment (e.g. Physical therapy, analgesics)
* Body Mass Index ≤ 41 kg/m2
* Ambulatory
* Willing and able to comply with the study procedures and visit schedules and ability to follow verbal and written instructions.
* Willingness to abstain from the use of protocol-restricted medications during the study after signing informed consent and also willing to abstain from use of all analgesics other than acetaminophen 1 week prior to beginning of treatment.
Exclusion Criteria:
* Current consumption of more than 14 alcoholic drinks per week
* Clinical signs and symptoms of active knee infection or crystal disease of either knee within 1 month of screening
* Diagnosed with rheumatoid arthritis, Reiter's syndrome, psoriatic arthritis, gout, ankylosing spondylitis, or arthritis secondary to other inflammatory diseases; HIV, …