Ignite Creation Date:
2026-03-26 @ 3:21 PM
Ignite Modification Date:
2026-04-01 @ 10:53 PM
Study NCT ID:
NCT00414427
Status:
COMPLETED
Last Update Posted:
2010-07-08
First Post:
2006-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Using Ultrasonography to Predict Clinical Response to Intraarticular Corticosteroids in Knee Osteoarthritis
Sponsor:
University of California, San Diego
Organization:
Study Overview
Official Title:
Using Ultrasonography to Predict Clinical Response to Intraarticular Corticosteroids in Knee Osteoarthritis
Status:
COMPLETED
Status Verified Date:
2006-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary purposes of this study are the following:
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. To prospectively evaluate clinical responsiveness of intraarticular corticosteroids with the inflammatory phenotype of knee OA using a randomized, placebo controlled clinical design.
3. To evaluate whether lower extremity strength is improved with intraarticular corticosteroid injection.
The investigators hypothesize that patients with signs of inflammation by ultrasonography such as synovitis and effusion will respond better to intraarticular corticosteroid injection.
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. To prospectively evaluate clinical responsiveness of intraarticular corticosteroids with the inflammatory phenotype of knee OA using a randomized, placebo controlled clinical design.
3. To evaluate whether lower extremity strength is improved with intraarticular corticosteroid injection.
The investigators hypothesize that patients with signs of inflammation by ultrasonography such as synovitis and effusion will respond better to intraarticular corticosteroid injection.
Detailed Description:
Osteoarthritis (OA) has previously been thought to be a non-inflammatory condition whose pathologic hallmark is destruction of hyaline cartilage. It is now realized that OA results from a complex interplay of multiple factors, including local inflammatory processes. Evidence suggests that synovitis which is the usual presenting sign of inflammatory arthritis is also frequently present in OA.
The presence of inflammation in knee OA may explain why intra-articular (IA) corticosteroid injections have been shown to result in clinically and statistically significant reduction in osteoarthritic knee pain. Randomized controlled trials have shown that treated patients were less likely to have continuing pain and had significantly lower scores on a visual analogue scale (VAS) for pain. However, studies have failed to determine clinical predictors of response to IA steroid injection, including traditional indices of inflammation (heat, fluid, stiffness). One possibility is that local corticosteroids do no act to relieve pain by reducing synovitis. These putative mechanisms have yet to be elucidated. Perhaps a more plausible explanation is that current methods of assessing local inflammation in OA are inadequate.
Recent studies involving ultrasonography (US) demonstrate that US is a valid and reproducible tool for the detection of synovitis in the knee. It has been shown to be more sensitive than clinical examination and is relatively inexpensive and noninvasive.
The presence of inflammation in knee OA may explain why intra-articular (IA) corticosteroid injections have been shown to result in clinically and statistically significant reduction in osteoarthritic knee pain. Randomized controlled trials have shown that treated patients were less likely to have continuing pain and had significantly lower scores on a visual analogue scale (VAS) for pain. However, studies have failed to determine clinical predictors of response to IA steroid injection, including traditional indices of inflammation (heat, fluid, stiffness). One possibility is that local corticosteroids do no act to relieve pain by reducing synovitis. These putative mechanisms have yet to be elucidated. Perhaps a more plausible explanation is that current methods of assessing local inflammation in OA are inadequate.
Recent studies involving ultrasonography (US) demonstrate that US is a valid and reproducible tool for the detection of synovitis in the knee. It has been shown to be more sensitive than clinical examination and is relatively inexpensive and noninvasive.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: