An Early Phase 1 interventional study of 40 mg Depo-Medrol in 1 ml, 9 ml of 1% lidocaine and Normal Saline 10 ml in Symptomatic Osteoarthritis of the Knee, sponsored by Rush University Medical Center. Withdrawn. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-12-18.
Sponsored by Rush University Medical Center · Early Phase 1, Interventional, and Treatment
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.
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Exclusion Criteria:
Using clinically accepted methods, subjects will undergo a palpation guided injection of corticosteroids into the knee joint. Subjects will then return for follow-up visit at 12 weeks for a physical exam of the knee. Patients will fill out questionnaires online at 1, 6, 12 and 24 weeks.
Drug: 40 mg Depo-Medrol in 1 ml, 9 ml of 1% lidocaine
Using clinically accepted methods, subjects will undergo a palpation guided injection of saline into the knee joint. Subjects will then return for follow-up visit at 12 weeks for a physical exam of the knee. Patients will fill out questionnaires online at 1, 6, 12 and 24 weeks.
Drug: Normal Saline 10 ml
Using clinically accepted methods, subjects will undergo a palpation guided injection of air into the knee joint. Subjects will then return for follow-up visit at 12 weeks for a physical exam of the knee. Patients will fill out questionnaires online at 1, 6, 12 and 24 weeks.
Drug: Air 10 ml
Patients will receive an ultrasound guided intra-articular injection of 40 mg Depo-Medrol in 1 ml, 9 ml of 1% lidocaine
Also known as: Corticosteroid
Patients will receive an ultrasound guided intra-articular injection of Normal Saline 10 ml
Also known as: Saline
Patients will receive an ultrasound guided intra-articular injection of Air 10 ml
Also known as: Air
Mean change in Western Ontario and McMaster Universities Arthritis Index score (WOMAC)
Mean change in the WOMAC Index score from baseline score
Time frame: 12 weeks after injection
Mean change in Knee injury and Osteoarthritis Outcome Score (KOOS)
Mean change in the KOOS from baseline score
Time frame: 12 weeks after injection
Mean change in International Knee Documentation Committee (IKDC) score
Mean change in IKDC from baseline score
Time frame: 12 weeks after injection
Mean change in Visual Analogue Scale (VAS)
Mean change in VAS from baseline score
Time frame: 12 weeks after injection
Mean change in Short Form 12 (SF-12) score
Mean change in SF-12 from baseline score
Time frame: 12 weeks after injection
Mean change in The Lysholm Knee score
Mean change in The Lysholm Knee score from baseline score
Time frame: 12 weeks after injection
Mean change in use of rescue medication
Use of anti-inflammatory, analgesics, and rescue corticosteroid injection. Number of pills taken each day. This will be collected via survey. If the medical examiner feels that the patient is continuing to do poorly and they did not receive the steroid injection intervention, then they will be offered a rescue corticosteroid injection at 12 weeks. The number of patients who do not initially receive a corticosteroid injection and require a rescue corticosteroid injection at 12 weeks will be recorded.
Time frame: 12 weeks after injection
No study locations are listed for this record.
Plan to share: No
This study is withdrawn, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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