Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Triamcinolone Acetonide Injectable · 1 trial · 1 indication
Quadriceps strength was measured in Newton Meters normalized to body weight of the individuals. Strength was assessed in 90 degrees of knee flexion.
The investigators assessed voluntary quadriceps central activation ratio as a representative variable of lower extremity neuromuscular activation using the supra imposition technique. Quadriceps central activation ratio has been demonstrated to be significantly decreased in knee osteoarthritis (OA) compared to healthy, matched controls, and the investigators have reported acceptable measurement reliability (ICC2,k = 0.85)
The peak Knee Flexion Angle was calculated using using inverse dynamics calculations in the first 50% of the stance phase of gait and during self selected gait speed.
The peak internal knee extension moment was calculated using using inverse dynamics calculations in the first 50% of the stance phase of gait and normalized to the Body Weight\* height (m) of the individual during self selected gait speed.
The Western Ontario and McMasters Universities Index is reliable and valid measure of self reported disability. The physical function consists of 17 items and asks about the magnitude of difficulty when ascending and descending stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on and taking off socks, rising from bed, lying in bed, getting in and out of the bath, sitting, getting on and off the toilet, completing heavy household duties, and completing light household duties. Each item is presented in a 5 point Likert-type format and uses the following descriptors for possible answer choices none, mild moderate, severe, and extreme. Each descriptor corresponds to an ordinal scale of 0-4. The scores are summed for the items in each subscale, with total possible ranges as 0-68. Higher scores on the WOMAC indicate greater amounts of functional limitations.
The Knee Injury and Osteoarthritis Outcomes Score (KOOS) consists of five subscales: Pain (9 items), Symptoms (7 items), Function in Activities of Daily Living (17 items), Function in Sport and Recreation (5 items) and Knee Related Quality of Life (4 items). Each item is presented in a 5 point Likert-type format that ranges from 0 (no problems) to 4 (extreme problems). Totals from each subscale are transformed to a 0-100 score. Lower scores on the KOOS indicate greater amounts of functional limitations.
Physical Activity Scale for the Elderly (PASE) scores are calculated from weights and frequency values for each of 12 types of activity. Responses to the first question about sitting activities are not scored. The scale is continuous with higher scores indicating greater physical activity.
The number of times that an individual can sit and stand in 30 seconds.
The investigators will time the amount of seconds it takes to walk 20 meters.
The investigators will time the amount of seconds it takes to walk up and down a flight of stairs.
Physical activity will be measured in the form of steps per day using an ActiGraph accelerometer. Participants will wear the ActiGraph for 7 days following each testing session.
| Arm | Type | Description |
|---|---|---|
| ZILRETTA Injection | EXPERIMENTAL | All patients upon enrolling in the study will receive a single 5 mL injection of 32 mg ZILRETTA into the affected knee joint. |
| Name | Type | Description |
|---|---|---|
| Triamcinolone Acetonide Extended-Release Injectable Suspension | DRUG | A single ZILRETTA® (triamcinolone acetonide extended-release injectable suspension) intra-articular knee injection. |
Full Inclusion Criteria: * Male or female between the ages of 40 and 75 years old who: * Exhibit symptomatic knee OA, defined as a normalized WOMAC function subscale score \>31(out of 100 points, indicating highest degree of dysfunction) * Have radiographic evidence of tibiofemoral OA (2-4 on the K...