NCT00746889

Brief Summary

A study using characteristics on ultrasound to predict response to intraarticular steroid injections in patients with knee osteoarthritis. The hypothesis is that patients with inflammation on ultrasound will have a better response to corticosteroid injections compared to patients without inflammation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

September 3, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 4, 2008

Completed
2 years until next milestone

Results Posted

Study results publicly available

August 25, 2010

Completed
Last Updated

August 25, 2010

Status Verified

September 1, 2008

Enrollment Period

4.3 years

First QC Date

September 3, 2008

Results QC Date

April 5, 2010

Last Update Submit

July 29, 2010

Conditions

Keywords

osteoarthritiskneecorticosteroidsultrasound

Outcome Measures

Primary Outcomes (1)

  • Change in Western Ontario and McMasters Universities Arthritis Index (WOMAC) Pain Subscale

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

    baseline to 4 weeks

Other Outcomes (1)

  • Change in WOMAC Pain Subscale

    baseline to 12 weeks

Study Arms (2)

Corticosteroid Injection

ACTIVE COMPARATOR

40 mg of intraarticular triamcinolone acetonide

Drug: triamcinolone acetonide

Placebo Injection

PLACEBO COMPARATOR

Intraarticular injection of 0.9% saline

Drug: saline

Interventions

single intraarticular injection of 40 mg of triamcinolone acetonide

Corticosteroid Injection
salineDRUG

Single intraarticular injection of 1 ml of 0.9% saline

Placebo Injection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • knee pain
  • diagnosis of osteoarthritis in affected knee

You may not qualify if:

  • intraarticular corticosteroids in affected knee within past three months
  • primary inflammatory connective tissue disease (ie rheumatoid arthritis)
  • currently taking oral corticosteroids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of California San Diego Medical Center

La Jolla, California, 92093, United States

Location

San Diego VA Hospital

La Jolla, California, 92161, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Triamcinolone AcetonideSodium Chloride

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

TriamcinolonePregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Results Point of Contact

Title
Jeannie Chao
Organization
UCSD

Study Officials

  • Kenneth Kalunian, MD

    University of California, San Diego

    PRINCIPAL INVESTIGATOR
  • Anna Quan, MD

    San Diego VA Hospital

    STUDY CHAIR
  • Michal Kalli Hose, MD

    San Diego VA Hospital

    STUDY DIRECTOR
  • Jeannie Chao, MD

    University of California, San Diego

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 3, 2008

First Posted

September 4, 2008

Study Start

March 1, 2004

Primary Completion

July 1, 2008

Study Completion

September 1, 2008

Last Updated

August 25, 2010

Results First Posted

August 25, 2010

Record last verified: 2008-09

Locations