150 Participants Needed

Triamcinolone + Ketorolac for Knee Osteoarthritis

(TriKe Trial)

TP
BK
Overseen ByBenjamin Kammerman, MD
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: United Health Services Hospitals, Inc.
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have used systemic steroids or opioids in the last 3 months.

Is the combination of Triamcinolone and Ketorolac generally safe for humans?

Ketorolac, a component of the treatment, has been associated with acute kidney problems and high potassium levels in some cases, especially in patients with existing risk factors. These issues were temporary and improved after stopping the medication.12345

How is the drug combination of Triamcinolone and Ketorolac unique for knee osteoarthritis?

This treatment combines Triamcinolone, a corticosteroid that reduces inflammation, with Ketorolac, a non-steroidal anti-inflammatory drug (NSAID) that relieves pain, offering a dual approach to managing knee osteoarthritis. The extended-release formulation of Triamcinolone allows for prolonged relief with reduced systemic side effects, making it a novel option compared to standard corticosteroid treatments.678910

What data supports the effectiveness of the drug Triamcinolone for knee osteoarthritis?

Research shows that intraarticular injections of triamcinolone hexacetonide can be effective in reducing pain and improving function in osteoarthritis, as seen in studies involving hand and knee joints.78111213

Who Is on the Research Team?

SH

Stanley Hunter, MD

Principal Investigator

United Health Services Hospitals, Inc.

Are You a Good Fit for This Trial?

This trial is for adults over 21 with knee pain from osteoarthritis, who can speak English well enough to fill out surveys. They must have had weight-bearing x-rays within the last year to check their arthritis stage and be willing to complete follow-up surveys.

Exclusion Criteria

I haven't taken steroids in the last 3 months.
My diabetes is not under control.
I have not had a knee injection in the last 3 months.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a one-time intra-articular injection of either ketorolac, triamcinolone, or a combination of both into the affected knee joint/s

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with surveys completed at 1 week, 6 weeks, 12 weeks, and possibly 24 weeks post-injection

24 weeks
4 visits (virtual or in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Ketorolac
  • Ropivacaine
  • Triamcinolone acetonide
Trial Overview The trial is testing injections into the knee joint: one with a cortisone drug called Triamcinolone, another with an anti-inflammatory called Ketorolac, and a mix of both. It aims to see if Ketorolac alone or combined with Triamcinolone works better than just Triamcinolone for knee arthritis.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Active Control
Group I: Triamcinolone acetonide - Ketorolac - RopivacaineExperimental Treatment1 Intervention
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
Group II: Ketorolac - Ropivacaine - Normal SalineExperimental Treatment1 Intervention
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
Group III: Triamcinolone acetonide - Ropivacaine - Normal SalineActive Control1 Intervention
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

Ketorolac is already approved in United States, European Union, Switzerland for the following indications:

๐Ÿ‡บ๐Ÿ‡ธ
Approved in United States as Toradol for:
  • Moderate to severe pain
  • Postoperative pain
  • Dysmenorrhea
  • Idiopathic pericarditis
  • Ocular itching
๐Ÿ‡ช๐Ÿ‡บ
Approved in European Union as Toradol for:
  • Moderate to severe pain
  • Postoperative pain
  • Dysmenorrhea
๐Ÿ‡บ๐Ÿ‡ธ
Approved in United States as Acular for:
  • Ocular itching
  • Inflammation after eye surgery
๐Ÿ‡บ๐Ÿ‡ธ
Approved in United States as Sprix for:
  • Moderate to severe pain
๐Ÿ‡จ๐Ÿ‡ญ
Approved in Switzerland as Ketorolac for:
  • Moderate to severe pain
  • Postoperative pain

Find a Clinic Near You

Who Is Running the Clinical Trial?

United Health Services Hospitals, Inc.

Lead Sponsor

Trials
2
Recruited
170+

Published Research Related to This Trial

Intra-articular injections of triamcinolone hexacetonide (TAH) and triamcinolone acetonide (TA) significantly raised blood glucose levels in patients with controlled diabetes and symptomatic osteoarthritis of the knee, with peak levels observed 24 to 32 hours post-injection.
In contrast, patients receiving hyaluronic acid (HA) injections did not experience significant increases in blood glucose, indicating that the rise in glucose levels is specifically associated with the steroid injections.
The effect of intra-articular triamcinolone preparations on blood glucose levels in diabetic patients: a controlled study.Habib, GS., Miari, W.[2022]
In a study of 60 osteoarthritis patients receiving intra-articular injections, triamcinolone hexacetonide combined with lidocaine significantly reduced joint swelling and decreased the need for pain relief medication over 48 weeks.
However, the treatment did not show any impact on the radiographic progression of osteoarthritis in the injected joints, indicating that while it helps with symptoms, it does not alter the underlying disease progression.
Intra-articular triamcinolone hexacetonide injections in hands osteoarthritis โ€’ A double-blinded randomized controlled trial with a one year follow-up.Paschoal, NOS., Natour, J., Machado, FS., et al.[2022]
In a study involving 85 children with oligoarticular juvenile idiopathic arthritis, intra-articular triamcinolone hexacetonide (TH) was found to be significantly more effective than triamcinolone acetonide (TA) in reducing joint inflammation, with response rates of 81.4% for TH compared to 53.3% for TA at 6 months.
The effectiveness of TH over TA was consistent over 24 months, indicating that TH may provide better long-term relief for patients, regardless of their disease duration or inflammation levels.
Comparison of intra-articular triamcinolone hexacetonide and triamcinolone acetonide in oligoarticular juvenile idiopathic arthritis.Zulian, F., Martini, G., Gobber, D., et al.[2015]

Citations

The effect of intra-articular triamcinolone preparations on blood glucose levels in diabetic patients: a controlled study. [2022]
Intra-articular triamcinolone hexacetonide injections in hands osteoarthritis โ€’ A double-blinded randomized controlled trial with a one year follow-up. [2022]
Comparison of intra-articular triamcinolone hexacetonide and triamcinolone acetonide in oligoarticular juvenile idiopathic arthritis. [2015]
Effectiveness of Triamcinolone Hexacetonide Intraarticular Injection in Interphalangeal Joints: A 12-week Randomized Controlled Trial in Patients with Hand Osteoarthritis. [2017]
Efficacy of Triamcinolone Hexacetonide versus Methylprednisolone Acetate Intraarticular Injections in Knee Osteoarthritis: A Randomized, Double-blinded, 24-week Study. [2022]
A comparative study of ketorolac (Toradol) and magnesium sulfate for arrest of preterm labor. [2019]
Ketorolac-induced acute renal failure and hyperkalemia: report of three cases. [2019]
Ketorolac tromethamine 0.5% ophthalmic solution in the treatment of moderate to severe ocular inflammation after cataract surgery: a randomized, vehicle-controlled clinical trial. [2019]
Adverse drug reactions associated with off-label use of ketorolac, with particular focus on elderly patients. An analysis of the Italian pharmacovigilance database and a population based study. [2018]
10.United Statespubmed.ncbi.nlm.nih.gov
The safety of intraocular ketorolac in rabbits. [2022]
Triamcinolone Acetonide Extended-Release: A Review in Osteoarthritis Pain of the Knee. [2023]
Intra-articular hyaluronic acid is superior to steroids in knee osteoarthritis: A comparative, randomized study. [2020]
Safety and Efficacy of Repeat Administration of Triamcinolone Acetonide Extended-release in Osteoarthritis of the Knee: A Phase 3b, Open-label Study. [2020]
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