Intraarticular Injections of the Hip and Knee With Triamcinolone Versus Ketorolac: A Randomized Controlled Trial

Study Overview
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Brief Summary
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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.

Official Title
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Intraarticular Injections of the Hip and Knee With Triamcinolone Versus Ketorolac: A Randomized Controlled Trial

Conditions
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Arthritis Knee, Arthritis of Hip

Intervention / Treatment
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* Drug: Ketorolac Intraarticular Injection
* Drug: Triamcinolone Intraarticular Injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketorolac Intraarticular Hip Injection<br>Patients will receive an intraarticular hip injection with ketorolac. | Drug: Ketorolac Intraarticular Injection<br>* Injections will be given under ultrasound guidance with one of two possible medications.<br>|
| Active Comparator: Triamcinolone Intraarticular Hip Injection<br>Patients will receive an intraarticular hip injection with triamcinolone. | Drug: Triamcinolone Intraarticular Injection<br>* Injections will be given under ultrasound guidance with one of two possible medications.<br>|
| Experimental: Ketorolac Intraarticular Knee Injection<br>Patients will receive an intraarticular knee injection with ketorolac. | Drug: Ketorolac Intraarticular Injection<br>* Injections will be given under ultrasound guidance with one of two possible medications.<br>|
| Active Comparator: Triamcinolone Intraarticular Knee Injection<br>Patients will receive an intraarticular knee injection with triamcinolone. | Drug: Triamcinolone Intraarticular Injection<br>* Injections will be given under ultrasound guidance with one of two possible medications.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Visual Analogue Scale (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) | Pain Score | Comparing baseline to one month post-injection | 
| Change in Visual Analogue Scale (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) | Overall patient wellbeing | Comparing baseline to one week post-injection | 
| Change in PROMIS Global Health Scores (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) | 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) | 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) | 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) | 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) | 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) | 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) | Functionality and pain of affected hip | Comparing baseline to three months post-injection |