Phase 4
N=140
Effect of Steroid Injections in a Knee With Osteoarthritis
Osteoarthritis (OA) of the Knee
Bottom Line
View on ClinicalTrials.gov: NCT01230424 ↗Enrolled (actual)
140
Serious AEs
30.0%
Results posted
Jul 2017
Primary outcome: Primary: Change in Mean Cartilage Thickness in the Index Compartment (Compartment With the Most Damage) — -0.21; -0.10 mm
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Triamcinolone Acetonide (Drug); 0.9% Sodium Chloride Injection as Placebo (Drug)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- All
- Sponsor
- Tufts Medical Center
- Primary completion
- Jan 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Mean Cartilage Thickness in the Index Compartment (Compartment With the Most Damage) |
-0.21; -0.10 | — |
| PRIMARY Change in Knee Pain Severity During the Past 48 Hours From the WOMAC LK3.1 Pain Score Questionnaire. |
-1.2; -1.9 | — |
| SECONDARY Change in Volume of Peri-articular Bone Marrow Lesions Measured on Knee MRI. |
0.9; 1.1 | — |
| SECONDARY Change in Effusion Volume Measured on Knee MRI. |
-0.1; -0.3 | — |
| SECONDARY Change in Area of Denudation Measured on Knee MRI in the Index Compartment (Compartment With the Most Damage). |
0.4; 0.4 | — |
| SECONDARY Change in Volumetric Cartilage Damage Index (CDI) Measured on Knee MRI in the Index Compartment (Compartment With the Most Damage). |
-133.7; -72.4 | — |
| SECONDARY Change in Function Severity During the Past 48 Hours From the WOMAC LK3.1 Function Score Questionnaire. |
-4.1; -5.1 | — |
| SECONDARY Change in Knee Stiffness During the Past 48 Hours From the WOMAC LK3.1 Stiffness Score Questionnaire. |
-0.6; -0.5 | — |
| SECONDARY Change in Patient's Global Assessment (Visual Analogue Scale). |
-2.7; -7.6 | — |
| SECONDARY Change in Time to Complete a Twenty-meter Walk. |
-0.3; 0.1 | — |
| SECONDARY Change in Time to Complete 5 Chair Stands. |
-1.1; -1.2 | — |
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 osteoarthritis (OA). The knee injection will be given once every 12 weeks over two years for a total of eight knee injections. How well each participant tolerates each injection and all the injections over time will be assessed. The safety of getting a knee injection every 12 weeks will be assessed by collecting reported adverse effects, knee examinations, and clinical laboratory tests. Participants will complete questionnaires, X-ray, MRIs, and bone density tests as part of this study.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01230424). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.