- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04441112
Intraarticular Injections of the Hip and Knee With Triamcinolone Versus Ketorolac: A Randomized Controlled Trial
June 18, 2020 updated by: Kevin Jurgensmeier, Saint Alphonsus Regional Medical Center
Clinicians commonly utilize intraarticular injections to treat symptomatic primary arthritis.
Steroid injections are common yet have immune-modulating effects and can alter gene expression which may delay definitive arthroplasty and further damage cartilage.
Non-steroidal anti-inflammatory (NSAID) injections may offer a safer profile due to their differing mechanism of action; however, there is a relative dearth of information regarding their efficacy.
This non-inferiority study compares the effectiveness of triamcinolone versus ketorolac in treating symptoms of moderate to advanced primary osteoarthritis of the hip and knee.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
120
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Idaho
-
Boise, Idaho, United States, 83706
- Saint Alphonsus Regional Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Symptomatic, radiographically proven degenerative joint disease in the hip or knee
Exclusion Criteria:
- recent injection in the hip or knee within the previous 3 months
- history of traumatic osteoarthritis or ligamentous reconstruction
- chronic narcotic use
- history of inflammatory or neuropathic arthropathy
- pregnant and/or nursing women
- allergy or strong reaction to study medications
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Ketorolac Intraarticular Hip Injection
Patients will receive an intraarticular hip injection with ketorolac.
|
Injections will be given under ultrasound guidance with one of two possible medications.
|
ACTIVE_COMPARATOR: Triamcinolone Intraarticular Hip Injection
Patients will receive an intraarticular hip injection with triamcinolone.
|
Injections will be given under ultrasound guidance with one of two possible medications.
|
EXPERIMENTAL: Ketorolac Intraarticular Knee Injection
Patients will receive an intraarticular knee injection with ketorolac.
|
Injections will be given under ultrasound guidance with one of two possible medications.
|
ACTIVE_COMPARATOR: Triamcinolone Intraarticular Knee Injection
Patients will receive an intraarticular knee injection with triamcinolone.
|
Injections will be given under ultrasound guidance with one of two possible medications.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Visual Analogue Scale (Baseline to One Week Post-injection)
Time Frame: Comparing baseline to one week post-injection
|
Pain Score
|
Comparing baseline to one week post-injection
|
Change in Visual Analogue Scale (Baseline to One Month Post-injection)
Time Frame: Comparing baseline to one month post-injection
|
Pain Score
|
Comparing baseline to one month post-injection
|
Change in Visual Analogue Scale (Baseline to Three Months Post-injection)
Time Frame: Comparing baseline to three months post-injection
|
Pain Score
|
Comparing baseline to three months post-injection
|
Change in PROMIS Global Health Scores (Baseline to One Week Post-injection)
Time Frame: Comparing baseline to one week post-injection
|
Overall patient wellbeing
|
Comparing baseline to one week post-injection
|
Change in PROMIS Global Health Scores (Baseline to One Month Post-injection)
Time Frame: Comparing baseline to one month post-injection
|
Overall patient wellbeing
|
Comparing baseline to one month post-injection
|
Change in PROMIS Global Health Scores (Baseline to Three Months Post-injection)
Time Frame: Comparing baseline to three months post-injection
|
Overall patient wellbeing
|
Comparing baseline to three months post-injection
|
Change in Knee Injury and Osteoarthritis Outcome Score Jr. (Baseline to One Week Post-injection)
Time Frame: Comparing baseline to one week post-injection
|
Functionality and pain of affected knee
|
Comparing baseline to one week post-injection
|
Change in Knee Injury and Osteoarthritis Outcome Score Jr. (Baseline to One Month Post-injection)
Time Frame: Comparing baseline to one month post-injection
|
Functionality and pain of affected knee
|
Comparing baseline to one month post-injection
|
Change in Knee Injury and Osteoarthritis Outcome Score Jr. (Baseline to Three Months Post-injection)
Time Frame: Comparing baseline to three months post-injection
|
Functionality and pain of affected knee
|
Comparing baseline to three months post-injection
|
Change in Hip Injury and Osteoarthritis Outcome Score Jr. (Baseline to One Week Post-injection)
Time Frame: Comparing baseline to one week post-injection
|
Functionality and pain of affected hip
|
Comparing baseline to one week post-injection
|
Change in Hip Injury and Osteoarthritis Outcome Score Jr. (Baseline to One Month Post-injection)
Time Frame: Comparing baseline to one month post-injection
|
Functionality and pain of affected hip
|
Comparing baseline to one month post-injection
|
Change in Hip Injury and Osteoarthritis Outcome Score Jr. (Baseline to Three Months Post-injection)
Time Frame: Comparing baseline to three months post-injection
|
Functionality and pain of affected hip
|
Comparing baseline to three months post-injection
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Kevin Jurgensmeier, BS, Student Investigator at Saint Alphonsus Regional Medical Center
- Study Chair: Steven B Daines, MD, Surgeon at Saint Alphonsus Regional Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 20, 2018
Primary Completion (ACTUAL)
August 20, 2019
Study Completion (ACTUAL)
August 20, 2019
Study Registration Dates
First Submitted
June 16, 2020
First Submitted That Met QC Criteria
June 18, 2020
First Posted (ACTUAL)
June 22, 2020
Study Record Updates
Last Update Posted (ACTUAL)
June 22, 2020
Last Update Submitted That Met QC Criteria
June 18, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Joint Diseases
- Musculoskeletal Diseases
- Arthritis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Ketorolac
- Triamcinolone
Other Study ID Numbers
- SaintAlphonsusRMC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
No plan currently decided.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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