Using Ultrasound to Predict Response to Intraarticular Corticosteroids in Knee Osteoarthritis

• Sponsor: University of California, San Diego
• 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
Enrollment	79

Participant Flow

Recruitment Details	Patients were recruited in rheumatology clinics at UCSD and the VA musculoskeletal clinic.
Pre-assignment Details	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.

Arm/Group Title	Corticosteroid Injection	Placebo
Arm/Group Description	40 mg of intraarticular triamcinolone acetonide	Intraarticular injection of 0.9% saline
Period Title: Overall Study
Started	40	39
Completed	36	35
Not Completed	4	4

Baseline Characteristics

Arm/Group Title		Corticosteroid Injection	Placebo	Total
Arm/Group Description		40 mg of intraarticular triamcinolone acetonide	Intraarticular injection of 0.9% saline	Total of all reporting groups
Overall Number of Baseline Participants		40	39	79
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	40 participants	39 participants	79 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	24 60.0%	23 59.0%	47 59.5%
	>=65 years	16 40.0%	16 41.0%	32 40.5%
Age Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	40 participants	39 participants	79 participants
		64 (12)	63 (12)	63 (12)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	40 participants	39 participants	79 participants
	Female	1 2.5%	2 5.1%	3 3.8%
	Male	39 97.5%	37 94.9%	76 96.2%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	40 participants	39 participants	79 participants
		40	39	79

Outcome Measures

1. Primary Outcome

Title	Change in Western Ontario and McMasters Universities Arthritis Index (WOMAC) Pain Subscale
Description	WOMAC pain subscale range 0-20 (0=best, 20=worst)
Time Frame	baseline to 4 weeks

Outcome Measure Data

Analysis Population Description

This population was defined as patients who completed the 4 week follow up assessment as per protocol.

Arm/Group Title	Corticosteroid Injection	Placebo
Arm/Group Description:	40 mg of intraarticular triamcinolone acetonide	Intraarticular injection of 0.9% saline
Overall Number of Participants Analyzed	33	34
Mean (Standard Deviation); Unit of Measure: units on a scale
	-2.1 (2.6)	-0.1 (1.9)

2. Other Pre-specified Outcome

Title	Change in WOMAC Pain Subscale
Description	WOMAC pain subscale range 0-20 (0=best, 20=worst)
Time Frame	baseline to 12 weeks

Outcome Measure Data

Analysis Population Description

These patients were categorized as inflammatory or noninflammatory based on the baseline ultrasound characteristics. All patients were in the treatment group.

Arm/Group Title	Inflammatory Patients Who Received Corticosteroid Injections	Noninflammatory Patients Who Received Corticosteroid Injection
Arm/Group Description:	Patients with inflammatory characteristics on ultrsaound who were treated with corticosteroid knee injections	Patients with noninflammatory characteristics on ultrasound who received saline placebo knee injections
Overall Number of Participants Analyzed	16	14
Mean (Standard Deviation); Unit of Measure: units on a scale
	-0.1 (3.2)	-2.0 (1.8)

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Corticosteroid Injection	Placebo
Arm/Group Description	40 mg of intraarticular triamcinolone acetonide	Intraarticular injection of 0.9% saline
All-Cause Mortality
	Corticosteroid Injection	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--
Serious Adverse Events
	Corticosteroid Injection	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/40 (0.00%)	0/39 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Corticosteroid Injection	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/40 (0.00%)	0/39 (0.00%)

Limitations and Caveats

[Not Specified]

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

EMail: 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