Triamcinolone Injections for Knee Osteoarthritis

Recruiting in Palo Alto (17 mi)

Overseen by Dien Hung Luong, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Must not be taking: Corticosteroids, Hyaluronic acid, Platelet-rich plasma

Disqualifiers: Bilateral gonarthrosis, Grade 4 osteoarthritis, others

No Placebo Group

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

Osteoarthritis of the knee is a common problem that is increasing in prevalence as the population ages. In a knee with osteoarthritis, there is variable damage to the articular cartilage and underlying bone that can cause varying degrees of pain. When pain is bothersome, osteoarthritis is treated to improve functional abilities. One of the most recognized and used treatments is intra-articular cortisone injection. Cortisone is a powerful anti-inflammatory drug that is used to reduce pain. Unfortunately, cortisone can have significant side effects, even when injected locally. The frequency and intensity of these side effects depend largely on the total dose injected. The main side effects include increased blood sugar levels, increased blood pressure and a temporary decrease in the secretion of the stress hormone, cortisol. In the long term, a decrease in articular cartilage thickness in the injected join and overall bone density reduction is also reported. Despite many years of routine use, the smallest effective dose of cortisone injected into the knee joint is unknown. The main objective of the study is to determine the impact on pain and function of different doses of cortisone injected into the knee. The cortisone chosen for this study is triamcinolone acetonide (TA).

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've had certain injections in the past 3 to 12 months or if you use oral corticosteroids regularly.

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

Triamcinolone Acetonide has shown effectiveness in treating severe asthma and uveitic macular edema, with significant improvements in symptoms. While these conditions are different from knee osteoarthritis, the drug's ability to reduce inflammation and improve symptoms in other conditions suggests it may also be beneficial for knee osteoarthritis.

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Is triamcinolone acetonide safe for use in humans?

Triamcinolone acetonide has been used in various treatments and is generally considered safe, but it can cause side effects like weight gain, menstrual disturbances, high blood pressure, and skin reactions. In rare cases, it may lead to more serious complications, such as eye issues when injected improperly.

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How does the drug triamcinolone acetonide differ from other treatments for knee osteoarthritis?

Triamcinolone acetonide is unique because it can be administered as an injection directly into the knee joint, providing targeted relief for osteoarthritis pain. This method allows for a prolonged effect, reducing the need for frequent dosing compared to oral medications, and it may have fewer systemic side effects.

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Eligibility Criteria

This trial is for individuals with knee pain due to osteoarthritis, rated between 4 and 8 on the pain scale, lasting over 6 months. Participants should have a specific grade of joint damage but not the most severe form or bilateral issues. They shouldn't have had recent cortisone injections or treatments like hyaluronic acid or platelet-rich plasma in their knees.

Inclusion Criteria

I have had knee arthritis symptoms for more than 6 months.

My knee arthritis is mild to severe but not the most severe.

My knee pain during activity is moderate but not severe.

Exclusion Criteria

I do not have any serious health issues that prevent me from joining the study.

I have pain in both knees due to arthritis.

My study joint is not affected by conditions like inflammation, infection, or bone death.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intra-articular injection of triamcinolone acetonide at doses of 5 mg, 10 mg, or 40 mg

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment using WOMAC and VAS scales

6 months

Follow-up assessments at 1, 2, 3, and 6 months post-injection

Participant Groups

The study tests three different doses of Triamcinolone Acetonide (5mg, 10mg, and 40mg) injected into the knee to determine which dose best reduces pain and improves function without causing significant side effects.

Group I: Group A TA 40 mg Experimental Treatment 1 Intervention

intra-articular injection of 40 mg of triamcinolone acetonide, which is the standard dose used

Group II: Group B TA 10 mg Active Control 1 Intervention

intra-articular injection of 10 mg of triamcinolone acetonide

Group III: Group C TA 5 mg Active Control 1 Intervention

intra-articular injection of 5 mg of triamcinolone acetonide

Triamcinolone Acetonide is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸 Approved in United States as Triamcinolone Acetonide for:

• Knee osteoarthritis
• Skin allergies
• Respiratory allergies

🇪🇺 Approved in European Union as Triamcinolone Acetonide for:

• Knee osteoarthritis
• Skin allergies
• Respiratory allergies

🇨🇦 Approved in Canada as Triamcinolone Acetonide for:

• Knee osteoarthritis
• Skin allergies
• Respiratory allergies

🇯🇵 Approved in Japan as Triamcinolone Acetonide for:

• Knee osteoarthritis
• Skin allergies
• Respiratory allergies

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Centre Hospitalier Universitaire de Montréal - Hôtel-Dieu Montréal, Canada

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM) Lead Sponsor

References

1. France pubmed.ncbi.nlm.nih.gov

[Safety and efficacy of subconjunctival triamcinolone injections in the management of uveitic macular edema: retrospective study of thirty-one cases]. [2014] Triamcinolone acetonide (Kenacort) is a corticosteroid that can be administrated by subconjunctival injection, with an extended release for up to three months. Our retrospective study aims to analyze safety and efficacy of subconjunctival triamcinolone injections in the treatment of uveitic macular edema. We included 31 eyes of 30 patients, who had one or several injections. We studied the progression of visual acuity, central macular thickness by optical coherence tomography (OCT), intraocular pressure, and presence or absence of cataract, on the day of injection (T0), and at 1, 3, 6 and 12 months after injection. Twenty-one patients had only one injection; 10 patients had 2. The 12-month follow-up showed an improvement in visual acuity with an initial mean of 0.36 ± 0.27 logMAR to 0.23 ± 0.33 logMAR at 3 months of follow-up (P

2. United States pubmed.ncbi.nlm.nih.gov

Corticosteroid injections of the nasal turbinates: past experience and precautions. [2019] Clinical experience with triamcinolone acetonide (Kenalog) injections into the nasal turbinates for allergic and vasomotor rhinitis is reported by two authors. Gratifying results have occurred in most of the over 60,000 patients treated, with no serious side effects. Two cases of intravascular injections of another corticosteroid reaching the retinal circulation are reported, and methods for preventing this complication are proposed.

3. Canada pubmed.ncbi.nlm.nih.gov

A randomized, single-blind comparison of the efficacy and tolerability of hylan G-F 20 and triamcinolone hexacetonide in patients with osteoarthritis of the knee. [2015] To assess prospectively the efficacy and tolerability of hylan G-F 20 (HG-F 20; Synvisc) and intraarticular triamcinolone hexacetonide (TH; Aristospan) for treatment of osteoarthritis (OA) knee pain in a 26 week, randomized, multicenter, evaluator-blind study.

4. England pubmed.ncbi.nlm.nih.gov

Subtenon Triamcinolone Acetonide Injection with Topical Anesthesia in Pediatric Non-Infectious Uveitis. [2023] Subtenon triamcinolone acetonide (Kenalog®; Bristol Myers Squibb) (STA) injections are commonly used in the treatment of adults in an outpatient setting. However, publications on detailing its outpatient use, safety, and efficacy in the pediatric population are scarce.

5. Singapore pubmed.ncbi.nlm.nih.gov

The use of triamcinolone acetonide in the treatment of severe intrinsic bronchial asthma. [2013] A group of 145 patients with severe intrinsic bronchial asthma symptoms was treated with repeated intramuscular injections of triamcinolone acetonide (Kenalog) during an average period of two years. Kenalog was administered mainly to persons with persistent attacks of asthmatic dyspnea and frequent recurrent infections of the respiratory tract in which other drugs, including orally administered steroids, did not lead to any improvement in the asthmatic symptoms. The results of therapy were excellent (total disappearance of asthmatic manifestations) or good (considerable improvement of asthma symptoms) in 88.3% of treated cases, while in 11.7% of patients, Kenalog had no effect. In 13.8% of cases, side effects, especially weight gain, disturbances in menstruation, increase in blood pressure, edema and spontaneous echymoses were observed. The triamcinolone acetonide depot-preparation is, in the authors' opinion, highly effective in the management of severe intrinsic asthma cases, unsucessfully treated by other methods. The prolonged use of Kenalog can, however, like other steroids provoke, several side effects.

6. United States pubmed.ncbi.nlm.nih.gov

Granulomatous Reaction to Intralesional Kenalog (Triamcinolone) Injection in Acne: A Case Report. [2020] Intralesional Kenalog (triamcinolone) injection is a useful treatment for several skin conditions. Although dermal deposition of triamcinolone has been described in the literature, histopathologic findings of foreign body reactions to it have seldom been reported. Here, we describe a case of a granulomatous reaction to the intralesional injection of triamcinolone acetonide in the treatment of nodulocystic acne.

7. China pubmed.ncbi.nlm.nih.gov

Presumed Sterile Endophthalmitis Afer Intravitreal Triamcinolone (Kenalog)-More Common and Less Benign Than We Thought? [2017] This study aimed to review the incidence and clinical outcome of presumed sterile endophthalmitis after the off-label use of intravitreal Kenalog injections (triamcinolone acetonide with 1.5% benzyl alcohol) and to compare it with the presumed sterile endophthalmitis incidence after intravitreal Kenacort-A (0.99% benzyl alcohol) at our center.

8. Germany pubmed.ncbi.nlm.nih.gov

Parenteral treatment of sarcoidosis with triamcinolone. [2013] The parenteral use of triamcinolone acetonide (Kenacort A) is said to have the following advantages: to keep the effect for two weeks by one injection, to be able to reduce the total treatment dosage and to secure the dosage regardless of patients cooperation. From these reasons, a trial of the Kenacort A treatment was made for 40 cases with sarcoidosis by 7 times of intramuscular injection at two-week intervals: 80 mg each at the 1st and 2nd and 40 mg at the 3rd to 7th. The results were compared with the already reported double blind trial using the oral initial dosage of 30 mg of prednisolone followed by a a reduced dosage for a period of 6 months. This paper will give an interim report of the 4 month follow-up after the ceasation of treatment. The results showed: 1. the disappearance rate of chest findings, either BHL or parenchymal pulmonary lesions, was higher in this trial than the above-mentioned oral treatment, 2. the high rate of improvement was found in ocular lesion, and 3. side effects were less in this trial than the oral treatment.