Status:
COMPLETED
Effect of Steroid Injections in a Knee With Osteoarthritis
Lead Sponsor:
Tufts Medical Center
Collaborating Sponsors:
Boston University
Conditions:
Osteoarthritis (OA) of the Knee
Eligibility:
All Genders
45+ years
Phase:
PHASE4
Brief Summary
A steroid (triamcinolone) 40 mg will be compared to placebo in a randomized placebo-controlled clinical trial testing the effect of this steroid versus placebo given into the study knee joint that has...
Detailed Description
This study was a two-year stratified and block-randomized double-blind, placebo controlled clinical trial of the effect of intra-articular triamcinolone 40 mg injectable suspension, administered every...
Eligibility Criteria
Inclusion
- Female or Male, Age ≥ 45 years
- Chronic knee discomfort based on affirmative response to the question "During the past 12 months, have you had any pain, aching, or stiffness in or around your knee(s) on most days for at least one month?"
- Baseline (Month 0) Pain score \>2 on at least one of the WOMAC weight-bearing pain questions; and total weight-bearing pain score \<8
- Tibiofemoral or patellofemoral OA on posterior-anterior weight-bearing semi-flexed or lateral knee radiographs with severity equivalent to Kellgren and Lawrence grade 2 or 3
- Evidence of synovitis on ultrasound at screening
- Clinical examination confirming knee pain or discomfort referable to the knee joint
- Prepared to discontinue NSAID(s)/analgesic(s) for 2 days prior to each assessment
Exclusion
- Prior septic (study) knee joint
- Prior reconstructive surgery in the study knee
- Prior osteonecrosis (avascular necrosis of bone)
- Chronic use of oral corticosteroids; knee intra-articular corticosteroid injection within 3 months of Month 0 (baseline) visit
- Ongoing use of doxycycline, indomethacin, glucosamine and/or chondroitin; or use of these within 2 months of Screening visit
- Evidence of other inflammatory joint disease (e.g., gout, CPPD)
- Serious medical conditions or impairments that, in the view of the investigator, would obstruct their participation in the trial such as uncontrolled diabetes, uncontrolled hypertension, opiate dependency
- Plan to permanently relocate from the region, or take an extended vacation for greater than 3 months during the trial period
- Planned arthroscopy and/or arthroplasty in the study knee.
- Any contra-indication to having an MRI
- Inability to speak or comprehend English
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT01230424
Start Date
March 1 2011
End Date
January 1 2015
Last Update
July 31 2017
Active Locations (2)
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1
Tufts Medical Center / Division of Rheumatology
Boston, Massachusetts, United States, 02111
2
Tufts Medical Center
Boston, Massachusetts, United States, 02111