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

Arthritis Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04441112
• Other study ID #: SaintAlphonsusRMC
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: May 20, 2018
• Est. completion date: August 20, 2019

Study information

• Verified date: June 2020
• Source: Saint Alphonsus Regional Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 20, 2019
• Est. primary completion date: August 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis Knee
• Arthritis of Hip

Intervention

Drug:
• Ketorolac Intraarticular Injection
Injections will be given under ultrasound guidance with one of two possible medications.
• Triamcinolone Intraarticular Injection
Injections will be given under ultrasound guidance with one of two possible medications.

Locations

Country	Name	City	State
United States	Saint Alphonsus Regional Medical Center	Boise	Idaho

Sponsors (1)

Lead Sponsor	Collaborator
Saint Alphonsus Regional Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Visual Analogue Scale (Baseline to One Week Post-injection)	Pain Score	Comparing baseline to one week post-injection
Primary	Change in Visual Analogue Scale (Baseline to One Month Post-injection)	Pain Score	Comparing baseline to one month post-injection
Primary	Change in Visual Analogue Scale (Baseline to Three Months Post-injection)	Pain Score	Comparing baseline to three months post-injection
Primary	Change in PROMIS Global Health Scores (Baseline to One Week Post-injection)	Overall patient wellbeing	Comparing baseline to one week post-injection
Primary	Change in PROMIS Global Health Scores (Baseline to One Month Post-injection)	Overall patient wellbeing	Comparing baseline to one month post-injection
Primary	Change in PROMIS Global Health Scores (Baseline to Three Months Post-injection)	Overall patient wellbeing	Comparing baseline to three months post-injection
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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