Triamcinolone Injections for Knee Osteoarthritis

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

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. ^{1 2 3 4 5}

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. ^{2 4 5 6 7}

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. ^{1 2 3 5 8}

Research Team

Dien Hung Luong, MD

Principal Investigator

Centre hospitalier de l'Université de Montréal (CHUM)

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.

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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 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]

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 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 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]

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]

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

Corticosteroid injections of the nasal turbinates: past experience and precautions. [2019]

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]

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

Subtenon Triamcinolone Acetonide Injection with Topical Anesthesia in Pediatric Non-Infectious Uveitis. [2023]

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

The use of triamcinolone acetonide in the treatment of severe intrinsic bronchial asthma. [2013]

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

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

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

Presumed Sterile Endophthalmitis Afer Intravitreal Triamcinolone (Kenalog)-More Common and Less Benign Than We Thought? [2017]

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

Parenteral treatment of sarcoidosis with triamcinolone. [2013]