Knee OsteoarthritisNCT00414427
Using Ultrasonography to Predict Clinical Response to Intraarticular Corticosteroids in Knee Osteoarthritis
A study testing Intraarticular steroids in people with Knee Osteoarthritis, run by University of California, San Diego at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Intraarticular steroids
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2005to Jun 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Thorton Hospital
La Jolla, California, 92037
La Jolla Veterans Affairs Medical Center
San Diego, California, 92161
About this study
The primary purposes of this study are the following:
- 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.
- 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.
Read the 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Intraarticular steroids
- Keywords
- Knee Osteoarthritis, Ultrasonography, Corticosteroids
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraarticular steroidsProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2006 (estimated)
- Study startDec 2005
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Investigators
- Kenneth Kalunian, M.D., Principal investigator, Univeristy of California at San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00414427
- Sponsor's protocol ID
- 051420
- Status last verified
- Dec 2006
- First submitted
- 20 Dec 2006
- Last updated
- 8 Jul 2010
- Results posted
- No
Publications
Godwin M, Dawes M. Intra-articular steroid injections for painful knees. Systematic review with meta-analysis. Can Fam Physician. 2004 Feb;50:241-8.
PubMed 15000335Gaffney 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.
PubMed 7794044Walther 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.
PubMed 11229463Karim 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.
PubMed 14872480Jones 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.
PubMed 8976640
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Ultrasonography to Predict Clinical Response to Intraarticular Corticosteroids in Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT00414427
- Acronym / sponsor ID
- 051420
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee Osteoarthritis, Ultrasonography, Corticosteroids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- Dec 2005
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 21 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purposes of this study are the following:
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraarticular steroids | Procedure or surgery | – |
Primary outcome
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.
1 secondary outcome
To evaluate whether lower extremity strength is improved with intraarticular corticosteroid injection.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2010.
- Background: PubMed 15000335Godwin M, Dawes M. Intra-articular steroid injections for painful knees. Systematic review with meta-analysis. Can Fam Physician. 2004 Feb;50:241-8.
- Background: PubMed 7794044Gaffney 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.
- Background: PubMed 11229463Walther 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.
- Background: PubMed 14872480Karim 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.
- Background: PubMed 8976640Jones 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth Kalunian, M.D. principal investigator
Univeristy of California at San Diego
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraarticular steroids in people with Knee Osteoarthritis, run by University of California, San Diego at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00414427, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2010.