Using Ultrasound to Predict Response to Intraarticular Corticosteroids in Knee Osteoarthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00746889
Recruitment Status : Completed
First Posted : September 4, 2008
Results First Posted : August 25, 2010
Last Update Posted : August 25, 2010
Information provided by:
University of California, San Diego

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double;   Primary Purpose: Treatment
Condition: Osteoarthritis
Interventions: Drug: triamcinolone acetonide
Drug: saline

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were recruited in rheumatology clinics at UCSD and the VA musculoskeletal clinic.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients taking oral corticosteroids, who had a primary inflammatory connective tissue disease, or who received IA corticosteroids in the affected knee within three months of study entry were excluded from the study.

Reporting Groups
Corticosteroid Injection 40 mg of intraarticular triamcinolone acetonide
Placebo Intraarticular injection of 0.9% saline

Participant Flow:   Overall Study
    Corticosteroid Injection   Placebo
STARTED   40   39 
COMPLETED   36   35 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
Corticosteroid Injection 40 mg of intraarticular triamcinolone acetonide
Placebo Intraarticular injection of 0.9% saline
Total Total of all reporting groups

Baseline Measures
   Corticosteroid Injection   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 40   39   79 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   24   23   47 
>=65 years   16   16   32 
[Units: Years]
Mean (Standard Deviation)
 64  (12)   63  (12)   63  (12) 
[Units: Participants]
Female   1   2   3 
Male   39   37   76 
Region of Enrollment 
[Units: Participants]
United States   40   39   79 

  Outcome Measures

1.  Primary:   Change in Western Ontario and McMasters Universities Arthritis Index (WOMAC) Pain Subscale   [ Time Frame: baseline to 4 weeks ]

2.  Other Pre-specified:   Change in WOMAC Pain Subscale   [ Time Frame: baseline to 12 weeks ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Jeannie Chao
Organization: UCSD
phone: 858-657-7040

Responsible Party: Kenneth Kalunian, University of California San Diego Identifier: NCT00746889     History of Changes
Other Study ID Numbers: IRB 051420
First Submitted: September 3, 2008
First Posted: September 4, 2008
Results First Submitted: April 5, 2010
Results First Posted: August 25, 2010
Last Update Posted: August 25, 2010