NCT00414427

Brief Summary

The primary purposes of this study are the following:

  1. 1.To evaluate whether the presence of inflammatory knee osteoarthritis as determined by ultrasonography can be used as a clinical predictor of patient response to intra-articular corticosteroids.
  2. 2.To prospectively evaluate clinical responsiveness of intraarticular corticosteroids with the inflammatory phenotype of knee OA using a randomized, placebo controlled clinical design.
  3. 3.To evaluate whether lower extremity strength is improved with intraarticular corticosteroid injection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P75+ for not_applicable knee-osteoarthritis

Timeline
Completed

Started Dec 2005

Longer than P75 for not_applicable knee-osteoarthritis

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

December 1, 2005

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 20, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 21, 2006

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

July 8, 2010

Status Verified

December 1, 2006

Enrollment Period

3.5 years

First QC Date

December 20, 2006

Last Update Submit

July 7, 2010

Conditions

Knee Osteoarthritis

Keywords

Knee OsteoarthritisUltrasonographyCorticosteroids

Outcome Measures

Primary Outcomes (2)

  • To evaluate whether the presence of inflammatory knee osteoarthritis as determined by ultrasonography can be used as a clinical predictor of patient response to intra-articular corticosteroids.

  • To prospectively evaluate clinical responsiveness of intraarticular corticosteroids with the inflammatory phenotype of knee OA using a randomized, placebo controlled clinical design.

Secondary Outcomes (1)

  • To evaluate whether lower extremity strength is improved with intraarticular corticosteroid injection.

Interventions

Intraarticular steroidsPROCEDURE

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Both male and female patients are eligible for the study if they are between 40 and 80 years old, have symptomatic knee OA requiring treatment, and have not responded adequately to treatment with acetominophen or NSAIDs.

You may not qualify if:

  • Severe OA as defined by radiographic Kellgren and Lawrence Grade IV
  • The patient being wheel-chair bound
  • Previous knee operation on the affected side within the past year or history of total knee arthroplasty (affected side)
  • Any IA steroid or injections in the last 3 months or viscosupplementation in the last 6 months
  • Local sepsis
  • Local skin conditions
  • Serious concomitant medical illness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Thorton Hospital

La Jolla, California, 92037, United States

Location

La Jolla Veterans Affairs Medical Center

San Diego, California, 92161, United States

Location

Related Publications (5)

  • Godwin M, Dawes M. Intra-articular steroid injections for painful knees. Systematic review with meta-analysis. Can Fam Physician. 2004 Feb;50:241-8.

    PMID: 15000335BACKGROUND

  • Gaffney K, Ledingham J, Perry JD. Intra-articular triamcinolone hexacetonide in knee osteoarthritis: factors influencing the clinical response. Ann Rheum Dis. 1995 May;54(5):379-81. doi: 10.1136/ard.54.5.379.

    PMID: 7794044BACKGROUND

  • Walther M, Harms H, Krenn V, Radke S, Faehndrich TP, Gohlke F. Correlation of power Doppler sonography with vascularity of the synovial tissue of the knee joint in patients with osteoarthritis and rheumatoid arthritis. Arthritis Rheum. 2001 Feb;44(2):331-8. doi: 10.1002/1529-0131(200102)44:23.0.CO;2-0.

    PMID: 11229463BACKGROUND

  • Karim Z, Wakefield RJ, Quinn M, Conaghan PG, Brown AK, Veale DJ, O'Connor P, Reece R, Emery P. Validation and reproducibility of ultrasonography in the detection of synovitis in the knee: a comparison with arthroscopy and clinical examination. Arthritis Rheum. 2004 Feb;50(2):387-94. doi: 10.1002/art.20054.

    PMID: 14872480BACKGROUND

  • Jones A, Doherty M. Intra-articular corticosteroids are effective in osteoarthritis but there are no clinical predictors of response. Ann Rheum Dis. 1996 Nov;55(11):829-32. doi: 10.1136/ard.55.11.829.

    PMID: 8976640BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Kenneth Kalunian, M.D.

    Univeristy of California at San Diego

    PRINCIPAL INVESTIGATOR

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

December 20, 2006

First Posted

December 21, 2006

Study Start

December 1, 2005

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

July 8, 2010

Record last verified: 2006-12

Locations

US(2)