Clinical trial NCT04441112: Intraarticular Injections of the Hip and Knee With Triamcinolone Versus Ketorolac: A Randomized Controlled Trial
Official title: Intraarticular Injections of the Hip and Knee With Triamcinolone Versus Ketorolac: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Arthritis Knee
Arthritis of Hip
Lead sponsor: Saint Alphonsus Regional Medical Center
Sponsor class: OTHER
First posted: 2020-06-22
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Visual Analogue Scale (Baseline to One Week Post-injection)
timeFrame: Comparing baseline to one week post-injection
measure: Change in Visual Analogue Scale (Baseline to One Month Post-injection)
timeFrame: Comparing baseline to one month post-injection
measure: Change in Visual Analogue Scale (Baseline to Three Months Post-injection)
timeFrame: Comparing baseline to three months post-injection
measure: Change in PROMIS Global Health Scores (Baseline to One Week Post-injection)
timeFrame: Comparing baseline to one week post-injection
measure: Change in PROMIS Global Health Scores (Baseline to One Month Post-injection)
timeFrame: Comparing baseline to one month post-injection
measure: Change in PROMIS Global Health Scores (Baseline to Three Months Post-injection)
timeFrame: Comparing baseline to three months post-injection
measure: Change in Knee Injury and Osteoarthritis Outcome Score Jr. (Baseline to One Week Post-injection)
timeFrame: Comparing baseline to one week post-injection
measure: Change in Knee Injury and Osteoarthritis Outcome Score Jr. (Baseline to One Month Post-injection)
timeFrame: Comparing baseline to one month post-injection
measure: Change in Knee Injury and Osteoarthritis Outcome Score Jr. (Baseline to Three Months Post-injection)
timeFrame: Comparing baseline to three months post-injection
measure: Change in Hip Injury and Osteoarthritis Outcome Score Jr. (Baseline to One Week Post-injection)
timeFrame: Comparing baseline to one week post-injection
measure: Change in Hip Injury and Osteoarthritis Outcome Score Jr. (Baseline to One Month Post-injection)
timeFrame: Comparing baseline to one month post-injection
measure: Change in Hip Injury and Osteoarthritis Outcome Score Jr. (Baseline to Three Months Post-injection)
timeFrame: Comparing baseline to three months post-injection
Secondary outcomes:
Other outcomes:
Locations:
city: Boise
country: United States
facility: Saint Alphonsus Regional Medical Center
state: Idaho
Study officials:
affiliation: Student Investigator at Saint Alphonsus Regional Medical Center
name: Kevin Jurgensmeier, BS
role: PRINCIPAL_INVESTIGATOR
affiliation: Surgeon at Saint Alphonsus Regional Medical Center
name: Steven B Daines, MD
role: STUDY_CHAIR
References:
citation: Jurgensmeier K, Jurgensmeier D, Kunz DE, Fuerst PG, Warth LC, Daines SB. Intra-articular Injections of the Hip and Knee With Triamcinolone vs Ketorolac: A Randomized Controlled Trial. J Arthroplasty. 2021 Feb;36(2):416-422. doi: 10.1016/j.arth.2020.08.036. Epub 2020 Aug 22.