Symptomatic Osteoarthritis of the Knee Clinical Trial
Official title:
Corticosteriods vs. Saline vs. Air Placebo Intra-articular Injections for Knee Osteoarthritis: A Single Blinded Prospective Randomized Trial
To investigate the clinical benefit of intra-articular injections of saline in patients with symptomatic osteoarthritis of the knee and compare the clinical response of saline to the current standard treatment with corticosteroids and an air injection placebo.
As non-surgical treatments of OA are essential, multiple trials have been done to compare
standard of care IA injection therapies to more novel injection treatments, with many of
these trials using saline as the control arm. The purpose of using a control arm is to
attempt to eliminate placebo effect and help distinguish the true effectiveness of a therapy.
There has been controversy over the clinical effect of saline in treating OA with some
arguing that saline may have some clinical benefit. If this is true, it could allow for the
true effect of standard of care therapies to appear diminished when compared to saline as a
placebo. A recent meta analysis looked at the use of saline as a placebo in 38 randomized
control trials to determine if intra-articular saline injections for knee OA had a clinical
effect. The study found that IA injections of saline significantly improved short-term knee
pain in 32 of the studies which involved 1705 patients, p <0.001, and long-term pain was
significantly decreased in 19 of the studies involving 1445 patients, p <0.001. It is
essential to empirically determine if saline has a clinical effect due to the role it plays
as a placebo in many clinical studies of the management of OA with intra-articular
injections.
Objective: To investigate the clinical benefit of intra-articular injections of saline in
patients with symptomatic osteoarthritis of the knee and compare the clinical response of
saline to the current standard treatment with corticosteroids and an air injection placebo.
Study Design: Prospective, single-blinded, randomized, clinical study. Patients will be
randomized into three treatment arms in a 1:1:1 fashion with approximately 50 patients in the
saline arm, 50 patients in the corticosteroid arm, and 50 patients in the placebo arm.
Null Hypothesis: Clinical knee outcomes of subjects following one intra-articular knee
injection of air will be similar to one intra-articular knee injection of saline or
corticosteroid for symptomatic patients diagnosed with knee OA.
Statistical Assumptions: Power Analysis
Investigational Arm: 10 ml Saline (Normal Saline)
Control Arm: 1 ml of 40 mg corticosteroid in 9 ml 1% lidocaine (Depo-medrol, Pfizer, New
York, New York), 10 ml air (placebo)
Primary Efficacy Endpoint: The primary efficacy endpoint is the mean change in the WOMAC
Index score 12 weeks after first injection with regards to baseline score.
Secondary Efficacy Secondary efficacy endpoints include the change in the full Endpoints:
WOMAC Index, KOOS, Lysholm, IKDC, VAS, SF-12 and use of rescue medication (steroid at 12
weeks).
Enrollment: Prospective, randomized, clinical study designed to evaluate 150 subjects. All
enrolled subjects will have a pre-procedure visit, one treatment visit, and follow-up visits
at week 6 and week 12 if they require a rescue injection and will fill out patient reported
outcome measures at 1, 6, 12, and 24 weeks.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04333160 -
Phase III Study on the Safety and Efficacy of a Single Intra-articular Administration of JTA-004 in Symptomatic Knee Osteoarthritis
|
Phase 3 |