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

NCT04441112 | Completed Phase 2 FDA Drug

• 1 other identifier: SaintAlphonsusRMC
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthritis Knee; Arthritis of Hip

Outcome Measures

Primary Outcomes (12)

• 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

Study Arms (4)

Ketorolac Intraarticular Hip Injection

EXPERIMENTAL

Patients will receive an intraarticular hip injection with ketorolac.

Drug: Ketorolac Intraarticular Injection

Triamcinolone Intraarticular Hip Injection

ACTIVE COMPARATOR

Patients will receive an intraarticular hip injection with triamcinolone.

Drug: Triamcinolone Intraarticular Injection

Ketorolac Intraarticular Knee Injection

EXPERIMENTAL

Patients will receive an intraarticular knee injection with ketorolac.

Drug: Ketorolac Intraarticular Injection

Triamcinolone Intraarticular Knee Injection

ACTIVE COMPARATOR

Patients will receive an intraarticular knee injection with triamcinolone.

Drug: Triamcinolone Intraarticular Injection

Interventions

Ketorolac Intraarticular Injection DRUG

Injections will be given under ultrasound guidance with one of two possible medications.

Ketorolac Intraarticular Hip Injection; Ketorolac Intraarticular Knee Injection

Triamcinolone Intraarticular Injection DRUG

Injections will be given under ultrasound guidance with one of two possible medications.

Triamcinolone Intraarticular Hip Injection; Triamcinolone Intraarticular Knee Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptomatic, radiographically proven degenerative joint disease in the hip or knee

You may not qualify if:

• 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

Sponsors & Collaborators

• Saint Alphonsus Regional Medical Center: lead

Study Sites (1)

Saint Alphonsus Regional Medical Center

Boise, Idaho, 83706, United States

Location

Related Publications (1)

• 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.

  PMID: 32950343 DERIVED

Study Officials

• Kevin Jurgensmeier, BS

  Student Investigator at Saint Alphonsus Regional Medical Center

  PRINCIPAL INVESTIGATOR

• Steven B Daines, MD

  Surgeon at Saint Alphonsus Regional Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Student

Study Record Dates

• First Submitted: June 16, 2020
• First Posted: June 22, 2020
• Study Start: May 20, 2018
• Primary Completion: August 20, 2019
• Study Completion: August 20, 2019
• Last Updated: June 22, 2020

Record last verified: 2020-06

Locations

US (1)