Using Ultrasound to Predict Response to Intraarticular Corticosteroids in Knee Osteoarthritis

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

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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
Overall Participants Analyzed; [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 ]

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2. Other Pre-specified:

Change in WOMAC Pain Subscale [ Time Frame: baseline to 12 weeks ]

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  Serious Adverse Events

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  Other Adverse Events

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  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

Responsible Party:	Kenneth Kalunian, University of California San Diego
ClinicalTrials.gov 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