- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01230424
Effect of Steroid Injections in a Knee With Osteoarthritis
Effect of Intra-articular Steroids on Structural Progression of Knee OA: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02111
- Tufts Medical Center
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Boston, Massachusetts, United States, 02111
- Tufts Medical Center / Division of Rheumatology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Triamcinolone Acetonide
40 mg into the study knee joint every 12 weeks for a total of 8 injections.
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40 mg into the study knee joint every 12 weeks for a total of 8 injections.
Other Names:
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Placebo Comparator: Sodium Chloride
0.9% Sodium chloride injection as Placebo will be given into the study knee once every 12 weeks for a total of 8 injections.
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Sodium chloride injection will be given into the study knee once every 12 weeks for a total of 8 injections.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Mean Cartilage Thickness in the Index Compartment (Compartment With the Most Damage)
Time Frame: Baseline to 2 years
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Mean cartilage thickness was measured on knee MRI (Philips Achieva X-Series 3.0 Tesla scanner).
Missing data were imputed.
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Baseline to 2 years
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Change in Knee Pain Severity During the Past 48 Hours From the WOMAC LK3.1 Pain Score Questionnaire.
Time Frame: Baseline to 2 years
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Pain subscale score was calculated from patient's responses on the Western Ontario and McMaster Universities Osteoarthritis Index Likert-type 3.1 Questionnaire. The questionnaire includes 24 items divided into 3 subscales, Pain, Stiffness, Physical Function. Only the Pain subscale score was used for this outcome measure. The Pain subscale consists of five items, each ranging from 0 to 4, making the total Pain subscore 0 to 20. Higher scores represent higher levels of pain, whereas lower scores represent lower levels of pain. Missing data were imputed. |
Baseline to 2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Volume of Peri-articular Bone Marrow Lesions Measured on Knee MRI.
Time Frame: Baseline to 2 years.
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Change in volume of peri-articular bone marrow lesions measured on knee MRI on the log scale.
Missing data were imputed.
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Baseline to 2 years.
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Change in Effusion Volume Measured on Knee MRI.
Time Frame: Baseline to 2 years
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Change in effusion volume measured on knee MRI on the log scale.
Missing data were imputed.
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Baseline to 2 years
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Change in Area of Denudation Measured on Knee MRI in the Index Compartment (Compartment With the Most Damage).
Time Frame: Baseline to 2 years
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Change in area of denudation measured on knee MRI in the index compartment (compartment with the most damage).
Missing data were imputed.
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Baseline to 2 years
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Change in Volumetric Cartilage Damage Index (CDI) Measured on Knee MRI in the Index Compartment (Compartment With the Most Damage).
Time Frame: Baseline to 2 years
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Change in volumetric cartilage damage index (CDI) measured on knee MRI in the index compartment (compartment with the most damage).
Missing data were imputed.
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Baseline to 2 years
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Change in Function Severity During the Past 48 Hours From the WOMAC LK3.1 Function Score Questionnaire.
Time Frame: Baseline to 2 years
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Physical Function subscale score was calculated from patient's responses on the Western Ontario and McMaster Universities Osteoarthritis Index Likert-type 3.1 Questionnaire. The questionnaire includes 24 items divided into 3 subscales, Pain, Stiffness, Physical Function. Only the Physical Function subscale score was used for this outcome measure. The Physical Function subscale consists of 17 items, each ranging from 0 to 4, making the total Function subscore 0 to 68. Higher scores represent higher levels of difficulty performing daily activities, whereas lower scores represent lower levels of difficulty performing daily activities. Missing data were imputed. |
Baseline to 2 years
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Change in Knee Stiffness During the Past 48 Hours From the WOMAC LK3.1 Stiffness Score Questionnaire.
Time Frame: Baseline to 2 years
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Stiffness subscale score was calculated from patient's responses on the Western Ontario and McMaster Universities Osteoarthritis Index Likert-type 3.1 Questionnaire. The questionnaire includes 24 items divided into 3 subscales, Pain, Stiffness, Physical Function. Only the Stiffness subscale score was used for this outcome measure. The Stiffness subscale consists of two items, each ranging from 0 to 4, making the total Stiffness subscore 0 to 8. Higher scores represent higher levels of stiffness, whereas lower scores represent lower levels of stiffness. Missing data were imputed. |
Baseline to 2 years
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Change in Patient's Global Assessment (Visual Analogue Scale).
Time Frame: Baseline to 2 years
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The response to the question, "Considering all the ways your knee affects you, how much pain are you having today?", was measured and the change in the scoring was evaluated.
The Patient's Global Assessment (PGA) is measured on a scale of 0 to 100 millimeters.
Higher scores represent a higher level of disease activity or a worse global health.
Missing data were imputed.
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Baseline to 2 years
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Change in Time to Complete a Twenty-meter Walk.
Time Frame: Baseline to 2 years
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Change in time (seconds) to complete a twenty-meter walk.
Missing data were imputed.
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Baseline to 2 years
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Change in Time to Complete 5 Chair Stands.
Time Frame: Baseline to 2 years
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Change in time (seconds) to complete 5 chair stands.
Missing data were imputed.
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Baseline to 2 years
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Timothy E. McAlindon, MD, MPH, Tufts Medical Center / Division of Rheumatology
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Arthritis
- Osteoarthritis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Immunosuppressive Agents
- Immunologic Factors
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Triamcinolone
- Triamcinolone Acetonide
- Triamcinolone hexacetonide
- Triamcinolone diacetate
Other Study ID Numbers
- NIH NIAMS R01-AR057802
- Tufts MC IRB Protocol # 9417 (Other Identifier: Tufts Medical Center)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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