Using Ultrasound to Predict Response to Intraarticular Corticosteroids in Knee Osteoarthritis

This study has been completed.
Sponsor:
Information provided by:
University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00746889
First received: September 3, 2008
Last updated: July 29, 2010
Last verified: September 2008
Results First Received: April 5, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double-Blind;   Primary Purpose: Treatment
Condition: Osteoarthritis
Interventions: Drug: triamcinolone acetonide
Drug: saline

  Participant Flow
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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
  Description
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  
NOT COMPLETED     4     4  



  Baseline Characteristics
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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
  Description
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  
Number of Participants  
[units: participants]
  40     39     79  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     24     23     47  
>=65 years     16     16     32  
Age  
[units: years]
Mean ± Standard Deviation
  64  ± 12     63  ± 12     63  ± 12  
Gender  
[units: participants]
     
Female     1     2     3  
Male     39     37     76  
Region of Enrollment  
[units: participants]
     
United States     40     39     79  



  Outcome Measures
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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
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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
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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
e-mail: j5chao@ucsd.edu


No publications provided


Responsible Party: Kenneth Kalunian, University of California San Diego
ClinicalTrials.gov Identifier: NCT00746889     History of Changes
Other Study ID Numbers: IRB 051420
Study First Received: September 3, 2008
Results First Received: April 5, 2010
Last Updated: July 29, 2010
Health Authority: United States: Institutional Review Board