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

June 18, 2020 updated by: Kevin Jurgensmeier, Saint Alphonsus Regional Medical Center
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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Idaho
      • Boise, Idaho, United States, 83706
        • Saint Alphonsus Regional Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Ketorolac Intraarticular Hip Injection
Patients will receive an intraarticular hip injection with ketorolac.
Injections will be given under ultrasound guidance with one of two possible medications.
ACTIVE_COMPARATOR: Triamcinolone Intraarticular Hip Injection
Patients will receive an intraarticular hip injection with triamcinolone.
Injections will be given under ultrasound guidance with one of two possible medications.
EXPERIMENTAL: Ketorolac Intraarticular Knee Injection
Patients will receive an intraarticular knee injection with ketorolac.
Injections will be given under ultrasound guidance with one of two possible medications.
ACTIVE_COMPARATOR: Triamcinolone Intraarticular Knee Injection
Patients will receive an intraarticular knee injection with triamcinolone.
Injections will be given under ultrasound guidance with one of two possible medications.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Visual Analogue Scale (Baseline to One Week Post-injection)
Time Frame: Comparing 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)
Time Frame: Comparing 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)
Time Frame: Comparing 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)
Time Frame: Comparing 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)
Time Frame: Comparing 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)
Time Frame: Comparing 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)
Time Frame: Comparing 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)
Time Frame: Comparing 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)
Time Frame: Comparing 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)
Time Frame: Comparing 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)
Time Frame: Comparing 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)
Time Frame: Comparing baseline to three months post-injection
Functionality and pain of affected hip
Comparing baseline to three months post-injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Kevin Jurgensmeier, BS, Student Investigator at Saint Alphonsus Regional Medical Center
  • Study Chair: Steven B Daines, MD, Surgeon at Saint Alphonsus Regional Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 20, 2018

Primary Completion (ACTUAL)

August 20, 2019

Study Completion (ACTUAL)

August 20, 2019

Study Registration Dates

First Submitted

June 16, 2020

First Submitted That Met QC Criteria

June 18, 2020

First Posted (ACTUAL)

June 22, 2020

Study Record Updates

Last Update Posted (ACTUAL)

June 22, 2020

Last Update Submitted That Met QC Criteria

June 18, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

No plan currently decided.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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