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

Phase 2

Completed

• Conditions: Arthritis Knee; Arthritis of Hip
• Interventions: Drug: Ketorolac Intraarticular Injection; Drug: Triamcinolone Intraarticular Injection

• Registration Number: NCT04441112
• Lead Sponsor: Saint Alphonsus Regional Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-20
• Primary Completion: 2019-08-20
• Study Completion: 2019-08-20
• Status Verified: 2020-06
• Study First Submitted: 2020-06-16
• Study First Submitted QC: 2020-06-18
• Last Update Submitted: 2020-06-18
• Study First Posted: 2020-06-22
• Last Update Posted: 2020-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketorolac Intraarticular Hip Injection	Ketorolac Intraarticular Injection	Patients will receive an intraarticular hip injection with ketorolac.
Triamcinolone Intraarticular Hip Injection	Triamcinolone Intraarticular Injection	Patients will receive an intraarticular hip injection with triamcinolone.
Ketorolac Intraarticular Knee Injection	Ketorolac Intraarticular Injection	Patients will receive an intraarticular knee injection with ketorolac.
Triamcinolone Intraarticular Knee Injection	Triamcinolone Intraarticular Injection	Patients will receive an intraarticular knee injection with triamcinolone.

Primary Outcome Measures

Name	Time	Method
Change in Visual Analogue Scale (Baseline to One Week Post-injection)	Comparing baseline to one week post-injection	Pain Score
Change in PROMIS Global Health Scores (Baseline to One Month Post-injection)	Comparing baseline to one month post-injection	Overall patient wellbeing
Change in Visual Analogue Scale (Baseline to One Month Post-injection)	Comparing baseline to one month post-injection	Pain Score
Change in Visual Analogue Scale (Baseline to Three Months Post-injection)	Comparing baseline to three months post-injection	Pain Score
Change in PROMIS Global Health Scores (Baseline to One Week Post-injection)	Comparing baseline to one week post-injection	Overall patient wellbeing
Change in PROMIS Global Health Scores (Baseline to Three Months Post-injection)	Comparing baseline to three months post-injection	Overall patient wellbeing
Change in Knee Injury and Osteoarthritis Outcome Score Jr. (Baseline to One Week Post-injection)	Comparing baseline to one week post-injection	Functionality and pain of affected knee
Change in Knee Injury and Osteoarthritis Outcome Score Jr. (Baseline to One Month Post-injection)	Comparing baseline to one month post-injection	Functionality and pain of affected knee
Change in Knee Injury and Osteoarthritis Outcome Score Jr. (Baseline to Three Months Post-injection)	Comparing baseline to three months post-injection	Functionality and pain of affected knee
Change in Hip Injury and Osteoarthritis Outcome Score Jr. (Baseline to One Week Post-injection)	Comparing baseline to one week post-injection	Functionality and pain of affected hip
Change in Hip Injury and Osteoarthritis Outcome Score Jr. (Baseline to One Month Post-injection)	Comparing baseline to one month post-injection	Functionality and pain of affected hip
Change in Hip Injury and Osteoarthritis Outcome Score Jr. (Baseline to Three Months Post-injection)	Comparing baseline to three months post-injection	Functionality and pain of affected hip

Trial Locations

Locations (1)

Saint Alphonsus Regional Medical Center; 🇺🇸 Boise, Idaho, United States