Effect of Steroid Injections in a Knee With Osteoarthritis

Osteoarthritis (OA) of the Knee Clinical Trial

— IACS for KOA  

Official title:

Effect of Intra-articular Steroids on Structural Progression of Knee OA: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01230424
• Other study ID #: NIH NIAMS R01-AR057802
• Secondary ID: Tufts MC IRB Pro
• Status: Completed
• Phase: Phase 4
• First received: October 27, 2010
• Last updated: December 14, 2015
• Start date: March 2011
• Est. completion date: January 2015

Study information

• Verified date: December 2015
• Source: Tufts Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: National Institutes of HealthUnited States: National Institute of Arthritis and Musculoskeletal and Skin DiseasesUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis (OA) of the Knee

Intervention

Drug:
• Triamcinolone Acetonide
40 mg into the study knee joint every 12 weeks for a total of 8 injections.
• 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.

Locations

Country	Name	City	State
United States	Tufts Medical Center	Boston	Massachusetts
United States	Tufts Medical Center / Division of Rheumatology	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Tufts Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary outcomes for this study are changes in pain and changes in knee cartilage volume.	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).	3.5 years	Yes

External Links

•   Tufts Medical Center Rheumatology Clinical Trials