Trial Outcomes & Findings for Using Ultrasound to Predict Response to Intraarticular Corticosteroids in Knee Osteoarthritis (NCT NCT00746889)

NCT ID: NCT00746889

Last Updated: 2010-08-25

Results Overview

WOMAC pain subscale range 0-20 (0=best, 20=worst)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 79 participants
• Primary outcome timeframe: baseline to 4 weeks
• Results posted on: 2010-08-25

Participant Flow

Patients were recruited in rheumatology clinics at UCSD and the VA musculoskeletal clinic.

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.

Participant milestones

Measure	Corticosteroid Injection 40 mg of intraarticular triamcinolone acetonide	Placebo Intraarticular injection of 0.9% saline
Overall Study STARTED	40	39
Overall Study COMPLETED	36	35
Overall Study NOT COMPLETED	4	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Using Ultrasound to Predict Response to Intraarticular Corticosteroids in Knee Osteoarthritis

Baseline characteristics by cohort

Measure	Corticosteroid Injection n=40 Participants 40 mg of intraarticular triamcinolone acetonide	Placebo n=39 Participants Intraarticular injection of 0.9% saline	Total n=79 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	24 Participants n=5 Participants	23 Participants n=7 Participants	47 Participants n=5 Participants
Age, Categorical >=65 years	16 Participants n=5 Participants	16 Participants n=7 Participants	32 Participants n=5 Participants
Age Continuous	64 years STANDARD_DEVIATION 12 • n=5 Participants	63 years STANDARD_DEVIATION 12 • n=7 Participants	63 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	39 Participants n=5 Participants	37 Participants n=7 Participants	76 Participants n=5 Participants
Region of Enrollment United States	40 participants n=5 Participants	39 participants n=7 Participants	79 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline to 4 weeks

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

WOMAC pain subscale range 0-20 (0=best, 20=worst)

Outcome measures

Measure	Corticosteroid Injection n=33 Participants 40 mg of intraarticular triamcinolone acetonide	Placebo n=34 Participants Intraarticular injection of 0.9% saline
Change in Western Ontario and McMasters Universities Arthritis Index (WOMAC) Pain Subscale	-2.1 units on a scale Standard Deviation 2.6	-0.1 units on a scale Standard Deviation 1.9

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline to 12 weeks

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

WOMAC pain subscale range 0-20 (0=best, 20=worst)

Outcome measures

Measure	Corticosteroid Injection n=16 Participants 40 mg of intraarticular triamcinolone acetonide	Placebo n=14 Participants Intraarticular injection of 0.9% saline
Change in WOMAC Pain Subscale	-0.1 units on a scale Standard Deviation 3.2	-2.0 units on a scale Standard Deviation 1.8

Adverse Events

Corticosteroid Injection

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jeannie Chao

UCSD

Phone: 858-657-7040

Email: j5chao@ucsd.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place