Osteoarthritis, KneePhase 4TriKeNCT05336968
Triamcinolone Ketorolac (TriKe) Knee Trial
A Phase 4 study testing Triamcinolone acetonide-Ketorolac-Ropivacaine in people with Osteoarthritis, Knee, run by United Health Services Hospitals, Inc. at 1 site in United States.
Trial summary
Cortisone injections are commonly used in the treatment of osteoarthrosis of the knee, but there are known detriments to cortisone including localized tissue atrophy near the injection site and acceleration of joint degeneration, as well as contraindications, such as uncontrolled diabetes. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Triamcinolone acetonide-Ketorolac-Ropivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2022to 31 Dec 2025
- Phase
- Phase 4
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Knee pain with diagnosis of osteoarthritis/osteoarthrosis
- Weight-bearing x-rays within the last year adequate to assess Kellgran-Lawrence OA stage
- Age > 21
- English proficiency sufficient to complete surveys
- Willing to complete follow-up surveys
Who cannot join
- Prior knee injection in last 3 months
- Knee surgery within the last year
- Contraindications to Cortisone, Ketorolac, or local anesthetic
- Uncontrolled diabetes
- Systemic steroid use in last 3 months
- BMI > 50
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- Non-ambulatory
- Known kidney disease
- Current opioid use
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
United Health Services Sports Medicine Department
Vestal, New York, 13850
Terri K Peters, RN MSN CCRP, 607-763-5697, terri.peters@nyuhs.org
Kathy A Hughes, RN MS, 607-763-5368, kathy.hughes@nyuhs.org
About this study
Official title: Triamcinolone Ketorolac (TriKe) Knee Trial Evaluating the Effectiveness and Possible Superiority of Ketorolac vs. Cortisone When Injected Intra-Articular in Subjects With Osteoarthrosis
Cortisone injections are commonly used in the treatment of osteoarthrosis of the knee, but there are known detriments to cortisone including localized tissue atrophy near the injection site and acceleration of joint degeneration, as well as contraindications, such as uncontrolled diabetes. Ketorolac is a non-steroidal anti-inflammatory with decades of clinical data that is most commonly injected intramuscularly. There is rising interest in using ketorolac as an intra-articular injectant substitute or adjunctive to cortisone. This may potentially improve clinical outcomes or decrease adverse effects. Although intra-articular use of ketorolac is increasing in orthopedics and sports medicine, there is limited data in the literature comparing these two injectants in prospective, randomized trials, and no data that evaluates combining the two injectants. Primary objectives are to evaluate the efficacy of intra-articular ketorolac compared to cortisone on knee osteoarthrosis and to evaluate whether the combination of ketorolac and cortisone is superior to either alone.
Read the detailed description
Charts will be prescreened for diagnosis or suspicion of osteoarthritis of the knee by the study staff. Those charts identified will be flagged for possible inclusion in the study. The receptionist will give the prospective subject a copy of the consent to read while they are in the waiting room. Once they are taken back to the room, the investigator will review the study with them. If they are agreeable, they will sign the consent and a copy will be given to them and a copy will be scanned into the Electronic Medical Record (EMR). The investigator will then notify the unblinded investigator, who will randomize the subject and prepare the medication in a blinded fashion. The subject will receive either ketorolac 30 mg, triamcinolone 40 mg, or a combination of the two medications as a one-time injection into the affected knee joint/s. The subject will be asked to complete a survey prior to receiving the injection, and again at 1 week, 6 weeks, and 12 weeks post injection. If necessary, an additional survey will be completed at 24 weeks post injection.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Triamcinolone acetonide-Ketorolac-Ropivacaine
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triamcinolone acetonide-Ketorolac-RopivacaineDrug
Experimental for Osteoarthrosis of the Knee. One randomized injection to intraarticularly into affected knee at time of randomization
| Study group | Role | What they receive |
|---|---|---|
| Triamcinolone acetonide - Ropivacaine - Normal Saline | Active comparator | Subject would receive:
Triamcinolone acetonide, 40 mg/mL. 1 mL Ropivacaine 0.2%, 2 mL Saline 0.9% 1 mL for a total of 4 mL injected intraarticularly into affected knee/s at randomization Receives: Drug: Triamcinolone acetonide-Ketorolac-Ropivacaine |
| Ketorolac - Ropivacaine - Normal Saline | Experimental | Subject would receive:
Ketorolac 30 mg/mL, 1 mL Ropivacaine 0.2%, 2 mL Saline 0.9% 1 mL for a total of 4 mL injected intraarticularly into affected knee/s at randomization Receives: Drug: Triamcinolone acetonide-Ketorolac-Ropivacaine |
| Triamcinolone acetonide - Ketorolac - Ropivacaine | Experimental | Subject would receive:
Triamcinolone acetonide, 40 mg/mL Ketorolac 30 mg/mL, 1 mL Ropivacaine 0.2%, 2 mL for a total of 4 mL injected intraarticularly into affected knee/s at randomization Receives: Drug: Triamcinolone acetonide-Ketorolac-Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in patient reported outcomes as measured by Modified KOOS scores
Change in patient reported outcomes as measured by Modified Knee Injury and Osteoarthritis Outcome Score (KOOS, higher is better [0-100]).
Measured: 12 -24 weeks
Evaluate whether the combination of ketorolac and cortisone is superior to either alone as measured by Modified KOOS
Change in patient reported outcomes as measured by Modified Knee Injury and Osteoarthritis Outcome Score (KOOS, higher is better [0-100])
Measured: 12 -24 weeks
Secondary outcomes (2)
Change in patient reported outcomes as measured by VAS
Change in patient reported outcomes as measured by Visual Analog Scale (VAS, lower is better [0-100])
Measured: 12 -24 weeks
Evaluate whether the combination of ketorolac and cortisone is superior to either alone as measured by VAS
Change in patient report outcomes as measured by Visual Analog Scale (VAS, lower is better [0-100])
Measured: 12 -24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start15 Sep 2022
- Primary completion30 Nov 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will receive either ketorolac 30 mg, triamcinolone 40 mg, or a combination of the two medications as a one-time injection into one or both affected knee joint/s.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- United Health Services Hospitals, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stanley Hunter, United Health Services Hospitals, Inc.
- Investigators
- Stanley Hunter, MD, Principal investigator, United Health Services Hospitals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05336968
- Sponsor's protocol ID
- UHSH-9940
- Acronym
- TriKe
- Status last verified
- May 2024
- First submitted
- 7 Feb 2022
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Triamcinolone Ketorolac (TriKe) Knee Trial Evaluating the Effectiveness and Possible Superiority of Ketorolac vs. Cortisone When Injected Intra-Articular in Subjects With Osteoarthrosis
- ClinicalTrials.gov ID
- NCT05336968
- Acronym / sponsor ID
- TriKe / UHSH-9940
- Conditions
- Osteoarthritis, Knee
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- United Health Services Hospitals, Inc.University, hospital or other
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 20 Apr 2022 (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.
Cortisone injections are commonly used in the treatment of osteoarthrosis of the knee, but there are known detriments to cortisone including localized tissue atrophy near the injection site and acceleration of joint degeneration, as well as contraindications, such as uncontrolled diabetes. Ketorolac is a non-steroidal anti-inflammatory with decades of clinical data that is most commonly injected intramuscularly. There is rising interest in using ketorolac as an intra-articular injectant substitute or adjunctive to cortisone. This may potentially improve clinical outcomes or decrease adverse effects. Although intra-articular use of ketorolac is increasing in orthopedics and sports medicine, there is limited data in the literature comparing these two injectants in prospective, randomized trials, and no data that evaluates combining the two injectants. Primary objectives are to evaluate the efficacy of intra-articular ketorolac compared to cortisone on knee osteoarthrosis and to evaluate whether the combination of ketorolac and cortisone is superior to either alone.
Detailed description
Charts will be prescreened for diagnosis or suspicion of osteoarthritis of the knee by the study staff. Those charts identified will be flagged for possible inclusion in the study. The receptionist will give the prospective subject a copy of the consent to read while they are in the waiting room. Once they are taken back to the room, the investigator will review the study with them. If they are agreeable, they will sign the consent and a copy will be given to them and a copy will be scanned into the Electronic Medical Record (EMR). The investigator will then notify the unblinded investigator, who will randomize the subject and prepare the medication in a blinded fashion. The subject will receive either ketorolac 30 mg, triamcinolone 40 mg, or a combination of the two medications as a one-time injection into the affected knee joint/s. The subject will be asked to complete a survey prior to receiving the injection, and again at 1 week, 6 weeks, and 12 weeks post injection. If necessary, an additional survey will be completed at 24 weeks post injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Subjects will receive either ketorolac 30 mg, triamcinolone 40 mg, or a combination of the two medications as a one-time injection into one or both affected knee joint/s.
| Arm | Type | Receives |
|---|---|---|
| Triamcinolone acetonide - Ropivacaine - Normal Saline | Active comparator | Drug: Triamcinolone acetonide-Ketorolac-RopivacaineSubject would receive: Triamcinolone acetonide, 40 mg/mL. 1 mL Ropivacaine 0.2%, 2 mL Saline 0.9% 1 mL for a total of 4 mL injected intraarticularly into affected knee/s at randomization |
| Ketorolac - Ropivacaine - Normal Saline | Experimental | Drug: Triamcinolone acetonide-Ketorolac-RopivacaineSubject would receive: Ketorolac 30 mg/mL, 1 mL Ropivacaine 0.2%, 2 mL Saline 0.9% 1 mL for a total of 4 mL injected intraarticularly into affected knee/s at randomization |
| Triamcinolone acetonide - Ketorolac - Ropivacaine | Experimental | Drug: Triamcinolone acetonide-Ketorolac-RopivacaineSubject would receive: Triamcinolone acetonide, 40 mg/mL Ketorolac 30 mg/mL, 1 mL Ropivacaine 0.2%, 2 mL for a total of 4 mL injected intraarticularly into affected knee/s at randomization |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Knee pain with diagnosis of osteoarthritis/osteoarthrosis
- Weight-bearing x-rays within the last year adequate to assess Kellgran-Lawrence OA stage
- Age > 21
- English proficiency sufficient to complete surveys
- Willing to complete follow-up surveys
Key exclusion criteria (9 listed)
- Prior knee injection in last 3 months
- Knee surgery within the last year
- Contraindications to Cortisone, Ketorolac, or local anesthetic
- Uncontrolled diabetes
- Systemic steroid use in last 3 months
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 |
|---|---|---|
| Triamcinolone acetonide-Ketorolac-RopivacaineExperimental for Osteoarthrosis of the Knee. One randomized injection to intraarticularly into affected knee at time of randomization | Drug | Ketorolac - Ropivacaine - Normal Saline, Triamcinolone acetonide - Ketorolac - Ropivacaine, Triamcinolone acetonide - Ropivacaine - Normal Saline |
Primary outcome
Change in patient reported outcomes as measured by Modified KOOS scores
Time frame: 12 -24 weeks
Change in patient reported outcomes as measured by Modified Knee Injury and Osteoarthritis Outcome Score (KOOS, higher is better [0-100]).
Evaluate whether the combination of ketorolac and cortisone is superior to either alone as measured by Modified KOOS
Time frame: 12 -24 weeks
Change in patient reported outcomes as measured by Modified Knee Injury and Osteoarthritis Outcome Score (KOOS, higher is better [0-100])
2 secondary outcomes
Change in patient reported outcomes as measured by VAS
Time frame: 12 -24 weeks
Evaluate whether the combination of ketorolac and cortisone is superior to either alone as measured by VAS
Time frame: 12 -24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
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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.
Stanley Hunter, MD principal investigator
United Health Services Hospitals, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Triamcinolone acetonide-Ketorolac-Ropivacaine in people with Osteoarthritis, Knee, run by United Health Services Hospitals, Inc. at 1 site in United States.
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 5 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 8 May 2024. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Terri Peters, RN MSN CCRP (607-763-5697, terri.peters@nyuhs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in patient reported outcomes as measured by Modified KOOS scores (time frame: 12 -24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 May 2024.