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

Primary Purpose

Arthritis Knee, Arthritis of Hip

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ketorolac Intraarticular Injection
Triamcinolone Intraarticular Injection
Sponsored by
Saint Alphonsus Regional Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthritis Knee

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Saint Alphonsus Regional Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

Ketorolac Intraarticular Hip Injection

Triamcinolone Intraarticular Hip Injection

Ketorolac Intraarticular Knee Injection

Triamcinolone Intraarticular Knee Injection

Arm Description

Patients will receive an intraarticular hip injection with ketorolac.

Patients will receive an intraarticular hip injection with triamcinolone.

Patients will receive an intraarticular knee injection with ketorolac.

Patients will receive an intraarticular knee injection with triamcinolone.

Outcomes

Primary Outcome Measures

Change in Visual Analogue Scale (Baseline to One Week Post-injection)
Pain Score
Change in Visual Analogue Scale (Baseline to One Month Post-injection)
Pain Score
Change in Visual Analogue Scale (Baseline to Three Months Post-injection)
Pain Score
Change in PROMIS Global Health Scores (Baseline to One Week Post-injection)
Overall patient wellbeing
Change in PROMIS Global Health Scores (Baseline to One Month Post-injection)
Overall patient wellbeing
Change in PROMIS Global Health Scores (Baseline to Three Months Post-injection)
Overall patient wellbeing
Change in Knee Injury and Osteoarthritis Outcome Score Jr. (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)
Functionality and pain of affected knee
Change in Knee Injury and Osteoarthritis Outcome Score Jr. (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)
Functionality and pain of affected hip
Change in Hip Injury and Osteoarthritis Outcome Score Jr. (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)
Functionality and pain of affected hip

Secondary Outcome Measures

Full Information

First Posted
June 16, 2020
Last Updated
June 18, 2020
Sponsor
Saint Alphonsus Regional Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04441112
Brief Title
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

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
May 20, 2018 (Actual)
Primary Completion Date
August 20, 2019 (Actual)
Study Completion Date
August 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Saint Alphonsus Regional Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis Knee, Arthritis of Hip

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ketorolac Intraarticular Hip Injection
Arm Type
Experimental
Arm Description
Patients will receive an intraarticular hip injection with ketorolac.
Arm Title
Triamcinolone Intraarticular Hip Injection
Arm Type
Active Comparator
Arm Description
Patients will receive an intraarticular hip injection with triamcinolone.
Arm Title
Ketorolac Intraarticular Knee Injection
Arm Type
Experimental
Arm Description
Patients will receive an intraarticular knee injection with ketorolac.
Arm Title
Triamcinolone Intraarticular Knee Injection
Arm Type
Active Comparator
Arm Description
Patients will receive an intraarticular knee injection with triamcinolone.
Intervention Type
Drug
Intervention Name(s)
Ketorolac Intraarticular Injection
Intervention Description
Injections will be given under ultrasound guidance with one of two possible medications.
Intervention Type
Drug
Intervention Name(s)
Triamcinolone Intraarticular Injection
Intervention Description
Injections will be given under ultrasound guidance with one of two possible medications.
Primary Outcome Measure Information:
Title
Change in Visual Analogue Scale (Baseline to One Week Post-injection)
Description
Pain Score
Time Frame
Comparing baseline to one week post-injection
Title
Change in Visual Analogue Scale (Baseline to One Month Post-injection)
Description
Pain Score
Time Frame
Comparing baseline to one month post-injection
Title
Change in Visual Analogue Scale (Baseline to Three Months Post-injection)
Description
Pain Score
Time Frame
Comparing baseline to three months post-injection
Title
Change in PROMIS Global Health Scores (Baseline to One Week Post-injection)
Description
Overall patient wellbeing
Time Frame
Comparing baseline to one week post-injection
Title
Change in PROMIS Global Health Scores (Baseline to One Month Post-injection)
Description
Overall patient wellbeing
Time Frame
Comparing baseline to one month post-injection
Title
Change in PROMIS Global Health Scores (Baseline to Three Months Post-injection)
Description
Overall patient wellbeing
Time Frame
Comparing baseline to three months post-injection
Title
Change in Knee Injury and Osteoarthritis Outcome Score Jr. (Baseline to One Week Post-injection)
Description
Functionality and pain of affected knee
Time Frame
Comparing baseline to one week post-injection
Title
Change in Knee Injury and Osteoarthritis Outcome Score Jr. (Baseline to One Month Post-injection)
Description
Functionality and pain of affected knee
Time Frame
Comparing baseline to one month post-injection
Title
Change in Knee Injury and Osteoarthritis Outcome Score Jr. (Baseline to Three Months Post-injection)
Description
Functionality and pain of affected knee
Time Frame
Comparing baseline to three months post-injection
Title
Change in Hip Injury and Osteoarthritis Outcome Score Jr. (Baseline to One Week Post-injection)
Description
Functionality and pain of affected hip
Time Frame
Comparing baseline to one week post-injection
Title
Change in Hip Injury and Osteoarthritis Outcome Score Jr. (Baseline to One Month Post-injection)
Description
Functionality and pain of affected hip
Time Frame
Comparing baseline to one month post-injection
Title
Change in Hip Injury and Osteoarthritis Outcome Score Jr. (Baseline to Three Months Post-injection)
Description
Functionality and pain of affected hip
Time Frame
Comparing baseline to three months post-injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin Jurgensmeier, BS
Organizational Affiliation
Student Investigator at Saint Alphonsus Regional Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Steven B Daines, MD
Organizational Affiliation
Surgeon at Saint Alphonsus Regional Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Saint Alphonsus Regional Medical Center
City
Boise
State/Province
Idaho
ZIP/Postal Code
83706
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
No plan currently decided.
Citations:
PubMed Identifier
32950343
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.
Results Reference
derived

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

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