Arthritis KneePhase 2/3NCT04441112

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

A Phase 2/3 study testing Ketorolac Intraarticular Injection and Triamcinolone Intraarticular Injection in people with Arthritis Knee and Arthritis of Hip, run by Saint Alphonsus Regional Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Arthritis Knee, Arthritis of Hip
What is being tested?: Ketorolac Intraarticular Injection and Triamcinolone Intraarticular Injection
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 1 siteUnited States
Study dates: 20 May 2018to 20 Aug 2019
Phase: Phase 2/3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Saint Alphonsus Regional Medical Center
Boise, Idaho, 83706

Other trials in United States

About this study

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
Being tested: Ketorolac Intraarticular Injection, Triamcinolone Intraarticular Injection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ketorolac Intraarticular InjectionDrug
Injections will be given under ultrasound guidance with one of two possible medications.
Triamcinolone Intraarticular InjectionDrug
Injections will be given under ultrasound guidance with one of two possible medications.

Study groups in NCT04441112
Study group	Role	What they receive
Ketorolac Intraarticular Hip Injection	Experimental	Patients will receive an intraarticular hip injection with ketorolac. Receives: Drug: Ketorolac Intraarticular Injection
Triamcinolone Intraarticular Hip Injection	Active comparator	Patients will receive an intraarticular hip injection with triamcinolone. Receives: Drug: Triamcinolone Intraarticular Injection
Ketorolac Intraarticular Knee Injection	Experimental	Patients will receive an intraarticular knee injection with ketorolac. Receives: Drug: Ketorolac Intraarticular Injection
Triamcinolone Intraarticular Knee Injection	Active comparator	Patients will receive an intraarticular knee injection with triamcinolone. Receives: Drug: Triamcinolone Intraarticular Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Visual Analogue Scale (Baseline to One Week Post-injection)
Pain Score
Measured: Comparing baseline to one week post-injection
Change in Visual Analogue Scale (Baseline to One Month Post-injection)
Pain Score
Measured: Comparing baseline to one month post-injection
Change in Visual Analogue Scale (Baseline to Three Months Post-injection)
Pain Score
Measured: Comparing baseline to three months post-injection
Change in PROMIS Global Health Scores (Baseline to One Week Post-injection)
Overall patient wellbeing
Measured: Comparing baseline to one week post-injection
Change in PROMIS Global Health Scores (Baseline to One Month Post-injection)
Overall patient wellbeing
Measured: Comparing baseline to one month post-injection
Change in PROMIS Global Health Scores (Baseline to Three Months Post-injection)
Overall patient wellbeing
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Comparing baseline to three months post-injection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 May 201820 Aug 2019

First posted22 Jun 2020
Study start20 May 2018
Primary completion20 Aug 2019
Study completion20 Aug 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Arthritis KneeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04441112
Sponsor's protocol ID: SaintAlphonsusRMC
Status last verified: Jun 2020
First submitted: 16 Jun 2020
Last updated: 22 Jun 2020
Results posted: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided: No plan currently decided.

Publications

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.
PubMed 32950343

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Arthritis Knee trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Intraarticular Injections of the Hip and Knee With Triamcinolone Versus Ketorolac: A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT04441112
Acronym / sponsor ID: SaintAlphonsusRMC
Conditions: Arthritis Knee, Arthritis of Hip
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: Saint Alphonsus Regional Medical CenterUniversity, hospital or other
Study start: 20 May 2018 (actual)
Primary completion: 20 Aug 2019 (actual)
Study completion: 20 Aug 2019 (actual)
First posted: 22 Jun 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 4

Arm	Type	Receives
Ketorolac Intraarticular Hip Injection	Experimental	Drug: Ketorolac Intraarticular InjectionPatients will receive an intraarticular hip injection with ketorolac.
Triamcinolone Intraarticular Hip Injection	Active comparator	Drug: Triamcinolone Intraarticular InjectionPatients will receive an intraarticular hip injection with triamcinolone.
Ketorolac Intraarticular Knee Injection	Experimental	Drug: Ketorolac Intraarticular InjectionPatients will receive an intraarticular knee injection with ketorolac.
Triamcinolone Intraarticular Knee Injection	Active comparator	Drug: Triamcinolone Intraarticular InjectionPatients will receive an intraarticular knee injection with triamcinolone.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ketorolac Intraarticular InjectionInjections will be given under ultrasound guidance with one of two possible medications.	Drug	Ketorolac Intraarticular Hip Injection, Ketorolac Intraarticular Knee Injection
Triamcinolone Intraarticular InjectionInjections will be given under ultrasound guidance with one of two possible medications.	Drug	Triamcinolone Intraarticular Hip Injection, Triamcinolone Intraarticular Knee Injection

Primary outcome

Change in Visual Analogue Scale (Baseline to One Week Post-injection)
Time frame: Comparing baseline to one week post-injection
Pain Score
Change in Visual Analogue Scale (Baseline to One Month Post-injection)
Time frame: Comparing baseline to one month post-injection
Pain Score
Change in Visual Analogue Scale (Baseline to Three Months Post-injection)
Time frame: Comparing baseline to three months post-injection
Pain Score
Change in PROMIS Global Health Scores (Baseline to One Week Post-injection)
Time frame: Comparing baseline to one week post-injection
Overall patient wellbeing
Change in PROMIS Global Health Scores (Baseline to One Month Post-injection)
Time frame: Comparing baseline to one month post-injection
Overall patient wellbeing
Change in PROMIS Global Health Scores (Baseline to Three Months Post-injection)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Comparing baseline to three months post-injection
Functionality and pain of affected hip

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2020.
Derived from this study: PubMed 32950343Jurgensmeier 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.
Individual participant dataSharing planned: Undecided. No plan currently decided.

Related trials for Arthritis Knee

Not yet recruiting
Holistic Healing for Knee Osteoarthritis
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Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
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Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
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The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
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Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kevin Jurgensmeier, BS principal investigator

Student Investigator at Saint Alphonsus Regional Medical Center

Steven B Daines, MD study chair

Surgeon at Saint Alphonsus Regional Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Visual Analogue Scale (Baseline to One Week Post-injection) (time frame: Comparing baseline to one week post-injection). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04441112, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2020.