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Effect of Steroid Injections in a Knee With Osteoarthritis (IACS for KOA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tufts Medical Center
ClinicalTrials.gov Identifier:
NCT01230424
First received: October 27, 2010
Last updated: December 14, 2015
Last verified: December 2015
  Purpose
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.

Condition Intervention Phase
Osteoarthritis (OA) of the Knee Drug: Triamcinolone Acetonide Drug: 0.9% Sodium Chloride Injection as Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Intra-articular Steroids on Structural Progression of Knee OA: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Tufts Medical Center:

Primary Outcome Measures:
  • Primary outcomes for this study are changes in pain and changes in knee cartilage volume. [ Time Frame: 3.5 years ]
    The primary clinical outcome will be assessed by changes in the WOMAC questionnaire. The primary pathological process measure will be change in knee cartilage volume as measured by magnetic resonance imaging (MRI).


Enrollment: 140
Study Start Date: March 2011
Study Completion Date: January 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Triamcinolone Acetonide
40 mg into the study knee joint every 12 weeks for a total of 8 injections.
Drug: Triamcinolone Acetonide
40 mg into the study knee joint every 12 weeks for a total of 8 injections.
Other Name: Kenalog
Placebo Comparator: Sodium Chloride
Sodium chloride injection will be given into the study knee once every 12 weeks for a total of 8 injections.
Drug: 0.9% Sodium Chloride Injection as Placebo
Sodium chloride injection will be given into the study knee once every 12 weeks for a total of 8 injections.
Other Name: Normal Saline for injection

  Eligibility

Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01230424

Locations
United States, Massachusetts
Tufts Medical Center / Division of Rheumatology
Boston, Massachusetts, United States, 02111
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Tufts Medical Center
Investigators
Principal Investigator: Timothy E. McAlindon, MD, MPH Tufts Medical Center / Division of Rheumatology
  More Information

Additional Information:
Responsible Party: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT01230424     History of Changes
Other Study ID Numbers: NIH NIAMS R01-AR057802
Tufts MC IRB Protocol # 9417 ( Other Identifier: Tufts Medical Center )
Study First Received: October 27, 2010
Last Updated: December 14, 2015

Keywords provided by Tufts Medical Center:
OA
Knee arthritis
MRI
Steroid

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 25, 2017