Triamcinolone Injections for Knee Osteoarthritis

Recruiting at 1 trial location

Overseen By Mathieu Boudier-Revéret, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

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 All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 day

327 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different doses of triamcinolone acetonide (a type of cortisone) affect pain and function in people with knee osteoarthritis. The researchers aim to identify the smallest dose that effectively reduces pain. Participants will receive one of three doses: 40 mg, 10 mg, or 5 mg. Individuals who have experienced knee pain due to osteoarthritis for more than six months and feel pain during activities might be suitable for this trial. As a Phase 4 trial, this research involves an FDA-approved treatment and seeks to understand how it can benefit more patients.

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 is the safety track record for triamcinolone acetonide?

Previous studies have widely used triamcinolone acetonide (TA), a type of cortisone, for knee osteoarthritis. It is often injected directly into the knee to reduce pain and swelling. While effective, some side effects require attention.

TA can raise blood sugar levels and blood pressure. It might also temporarily lower cortisol, the body's natural stress hormone. Long-term use may thin joint cartilage and decrease overall bone strength. These effects largely depend on the injected amount.

For safety, TA is unsuitable for individuals allergic to corticosteroids or any injection ingredients. Those with such allergies should not receive this treatment.

The trial explores different doses to find the smallest effective amount, potentially managing side effects better. While TA is a common treatment, finding the right dose is key to balancing effectiveness and safety. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about triamcinolone acetonide injections for knee osteoarthritis because they offer a potential improvement over standard treatments like NSAIDs and physical therapy. Unlike these options, triamcinolone acetonide is a corticosteroid that is directly injected into the knee joint, providing targeted anti-inflammatory effects. This method can lead to quicker pain relief and reduced swelling without the systemic side effects associated with oral medications. Additionally, the trial is exploring different dosages—40 mg, 10 mg, and 5 mg—to optimize effectiveness while minimizing potential side effects, offering a more personalized approach to treatment.

What is the effectiveness track record for triamcinolone injections in treating knee osteoarthritis?

Research has shown that injecting triamcinolone acetonide (TA) into the knee can effectively reduce pain for people with knee osteoarthritis. This trial will compare different doses of TA: Group A will receive a 40 mg dose, Group B a 10 mg dose, and Group C a 5 mg dose. One study found that both 10 mg and 40 mg doses of TA significantly eased pain, with the 10 mg dose working just as well as the 40 mg dose. Other studies have reported quick relief from knee pain, along with improvements in stiffness, movement, and overall knee health. The extended-release version of TA has also provided long-lasting pain relief and better physical function for several weeks. These findings support using TA to manage knee osteoarthritis pain. ^{5 6 7 8 9}

Who Is on the Research Team?

Dien Hung Luong, MD

Principal Investigator

Centre hospitalier de l'Université de Montréal (CHUM)

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Triamcinolone Acetonide

Trial Overview

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.

How Is the Trial Designed?

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

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials

389

Recruited

143,000+

Published Research Related to This Trial

In a study of 31 eyes from 30 patients, subconjunctival injections of triamcinolone acetonide significantly improved visual acuity and reduced central macular thickness over 12 months, indicating its efficacy in treating uveitic macular edema.

The treatment was found to be safe, with no significant increase in intraocular pressure and only one cataract diagnosed, which occurred in an uninjected eye, suggesting minimal risk of adverse effects.

NCBI (Pubmed)

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]. Bleriot, A., Couret, C., Le Meur, G., et al.[2014]

Intralesional Kenalog (triamcinolone) is an effective treatment for skin conditions like nodulocystic acne, demonstrating its therapeutic potential.

However, this case highlights a rare but significant side effect: a granulomatous reaction, indicating that while the treatment is beneficial, it can also lead to adverse histopathological responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Granulomatous Reaction to Intralesional Kenalog (Triamcinolone) Injection in Acne: A Case Report. Song, Y., Guo, Y.[2020]

In a study involving 30 children with non-infectious uveitis, subtenon triamcinolone acetonide (STA) injections showed significant efficacy, with 85.4% of eyes experiencing inflammation improvement and 77.8% resolution of macular edema at the 3-month follow-up.

The procedure was safe, with no immediate complications reported, and only a 12.5% incidence of ocular hypertension at 6 months, indicating that STA injections are a well-tolerated treatment option for pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subtenon Triamcinolone Acetonide Injection with Topical Anesthesia in Pediatric Non-Infectious Uveitis. Jung, JL., Harasawa, M., Patnaik, JL., et al.[2023]

In a study of 81 patients receiving intravitreal Kenalog injections, 12.3% developed presumed sterile endophthalmitis, indicating a significant risk associated with this treatment.

While all cases of inflammation resolved with treatment, two patients experienced serious complications that led to a loss of best corrected visual acuity, highlighting the potential for severe outcomes despite the generally benign nature of sterile endophthalmitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Presumed Sterile Endophthalmitis Afer Intravitreal Triamcinolone (Kenalog)-More Common and Less Benign Than We Thought? Fong, AH., Chan, CK.[2017]

In a study of 145 patients with severe bronchial asthma, repeated intramuscular injections of triamcinolone acetonide (Kenalog) resulted in excellent or good outcomes in 88.3% of cases, indicating its high efficacy for patients who did not respond to other treatments.

While Kenalog was effective, 13.8% of patients experienced side effects such as weight gain and increased blood pressure, highlighting the need for careful monitoring during prolonged steroid use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of triamcinolone acetonide in the treatment of severe intrinsic bronchial asthma. Romański, B., Pawlik, K., Wilewska-Klubo, T.[2013]

In a 26-week study involving 215 patients with osteoarthritis, hylan G-F 20 (HG-F 20) provided significantly better pain relief and functional improvement compared to triamcinolone hexacetonide (TH) at both 12 and 26 weeks.

HG-F 20 demonstrated a longer duration of effect and was better tolerated, with no patients discontinuing treatment due to lack of efficacy, while 15 patients treated with TH did discontinue for this reason.

NCBI (Pubmed)

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. Caborn, D., Rush, J., Lanzer, W., et al.[2015]

In a trial involving 40 sarcoidosis patients treated with intramuscular triamcinolone acetonide (Kenacort A), the treatment showed a higher rate of improvement in chest findings compared to oral prednisolone, indicating its efficacy.

The intramuscular treatment also resulted in fewer side effects and a significant improvement in ocular lesions, suggesting it may be a safer alternative to oral corticosteroids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parenteral treatment of sarcoidosis with triamcinolone. Mikami, R., Hiraga, Y., Yotsumoto, H., et al.[2013]

Triamcinolone acetonide (Kenalog) injections into the nasal turbinates have been successfully used in over 60,000 patients for treating allergic and vasomotor rhinitis, showing positive results without serious side effects.

The authors highlight the importance of preventing complications, such as intravascular injections that can affect the retinal circulation, by proposing specific methods to avoid this risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Corticosteroid injections of the nasal turbinates: past experience and precautions. McCleve, D., Goldstein, J., Silver, S.[2019]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9896831/

The efficacy of intra-articular triamcinolone acetonide 10 ...

The 10 mg of TA is non-inferior to 40 mg TA in improving pain in patients with symptomatic knee OA. Both 10 mg and 40 mg of TA significantly improved pain and ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6824457/

Efficacy of Triamcinolone Acetonide Extended-Release in ...

People receiving the extended-release steroid injection had greater improvements in osteoarthritis pain, stiffness, function, and knee-related ...

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zilrettapro.com

zilrettapro.com/efficacy

ZILRETTA® Efficacy Data | Clinical Trial Results

Rapid, persistent, and proven relief from OA knee pain · Rapid—4 days median time to onset with ZILRETTA® (triamcinolone acetonide extended-release injectable ...

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clinicaltrials.gov

clinicaltrials.gov/study/NCT06478186

Knee Osteoarthritis Treatment With Zilretta vs. Kenalog in ...

The primary outcome will be measured 72 hours after treatment by a sensor automatically uploading the data, thus we expect few dropouts are expected. Official ...

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S266591312200036X

The effect of intra-articular extended-release triamcinolone ...

These data indicate improvement in chair stand performance through 12 weeks post-injection and sustained improvement in participant-reported physical function ...

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zilrettapro.com

zilrettapro.com/safety-data

ZILRETTA® Safety Profile | Tolerability Data for HCPs

Contraindication: ZILRETTA is contraindicated in patients who are hypersensitive to triamcinolone acetonide, corticosteroids, or any components of the product.

7.

zilretta.com

zilretta.com/important-risk-information

ZILRETTA® Safety Information | Risks & Side Effects

You should not receive a ZILRETTA injection if you are allergic to corticosteroids, triamcinolone acetonide, or any other component of the product. What ...

8.

accessdata.fda.gov

accessdata.fda.gov/drugsatfda_docs/label/2017/208845s000lbl.pdf

4163229 This label may not be the latest approved by FDA ...

The efficacy and safety of repeat administration of ZILRETTA for the management of osteoarthritis pain of the knee have not been evaluated. • The efficacy and ...

9.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8363704/

Safety and Systemic Exposure of Triamcinolone Acetonide ...

These observations are also supported by data from a phase 2 study in patients with knee OA showing prolonged bioavailability of TA-ER in the synovial fluid (SF) ...