Corticosteroid + Anesthetic Injection for Knee Osteoarthritis

(Injections Trial)

Overseen By Debbi Warren, RN

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Foundation for Orthopaedic Research and Education

Must not be taking: Narcotics

Disqualifiers: Inflammatory arthritis, Pregnancy, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

75 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests injections for knee osteoarthritis to determine if adding an anesthetic (a pain-numbing medicine) to a corticosteroid (an anti-inflammatory medicine) enhances pain relief. Researchers aim to discover whether the anesthetic increases the treatment's effectiveness and the duration of pain relief. Participants will receive one of three injections: corticosteroid alone, corticosteroid with 4ml of anesthetic, or corticosteroid with a specific anesthetic mixture (Kenalog with bupivacaine Injection). The trial seeks individuals diagnosed with primary knee osteoarthritis and moderate symptoms (Kellgren Lawrence Stage II or III). As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment approach.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. However, if you have been using narcotics in the past 6 months, you cannot participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that using Kenalog, a type of steroid, with bupivacaine, a pain reliever, is generally safe for treating knee osteoarthritis. Studies have found that injecting Kenalog into the knee can reduce pain and improve movement without major issues. The most common side effects include minor pain or bleeding at the injection site, while serious problems like joint infections are very rare.

One study found that mixing Kenalog with bupivacaine does not increase the risk of harming cartilage cells, suggesting this combination does not damage the joint. However, bupivacaine alone might harm cartilage if not prepared correctly, so proper mixing is important.

Overall, evidence suggests that Kenalog with bupivacaine is well-tolerated, meaning most people can use it without serious side effects. However, discussing any concerns with a healthcare provider before joining a trial is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Most treatments for knee osteoarthritis, like oral pain relievers and physical therapy, focus on managing symptoms over time. But Kenalog with bupivacaine injections work differently, offering targeted relief directly to the joint. This approach combines a synthetic corticosteroid with an anesthetic, potentially providing faster and more localized pain relief. The trial explores different formulations—one with no bupivacaine, one with 4ml, and one with a 0.25% concentration—allowing researchers to determine the most effective combination for reducing pain and inflammation. Researchers are excited because this could lead to more personalized and effective treatments for knee osteoarthritis, offering patients quicker relief.

What evidence suggests that this trial's treatments could be effective for knee osteoarthritis?

Research has shown that steroid injections into the knee joint, such as Kenalog, can effectively reduce pain and swelling from knee osteoarthritis. In this trial, participants will receive Kenalog injections with varying amounts of bupivacaine, a local pain reliever, to assess immediate pain relief after the injection. Other studies have found that both 0.5% and 0.25% strengths of bupivacaine significantly ease pain shortly after the procedure and for up to a week. Additionally, combining triamcinolone (the active ingredient in Kenalog) with bupivacaine did not increase cell damage in studies, indicating it is safe for use in joints. This treatment has shown promise in relieving knee pain from osteoarthritis, but its effectiveness can vary depending on the strength and amount of the anesthetic used. ^{2 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with moderate osteoarthritis (Kellgren Lawrence Stage II or III) who can give consent. It's not suitable for those outside this group.

Inclusion Criteria

My arthritis is moderate to severe.

I have been diagnosed with primary osteoarthritis.

Exclusion Criteria

History of narcotic use for the past 6 months

Pregnant women and prisoners

I have a type of arthritis that causes joint inflammation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one intra-articular knee injection of synthetic corticosteroid (Kenalog) with variable amounts of anesthetic

1 day

1 visit (in-person)

Follow-up

Participants are monitored for pain relief and adverse events using the VAS pain score and other assessments

12 weeks

Multiple assessments (virtual or in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Kenalog with bupivacaine Injection

Trial Overview The study tests pain relief from corticosteroid injections, both with and without anesthetic, in knee osteoarthritis patients. Pain levels are tracked over time to see how long relief lasts and how well different mixtures work.

How Is the Trial Designed?

Group I: Kenalog with 4ml bupivacaine Experimental Treatment 1 Intervention

The intervention in this study is one intra-articular knee injection of synthetic corticosteroid (kenalog) and variable amount of anesthetic,4ml of bupivacaine. The patients will be randomized into this group.

Group II: Kenalog with 0ml bupivacaine Experimental Treatment 1 Intervention

The intervention in this study is one intra-articular knee injection of synthetic corticosteroid (kenalog) and variable amount of anesthetic,0ml of bupivacaine. The patients will be randomized into this group.

Group III: Kenalog with 0.25% bupivacaine Experimental Treatment 1 Intervention

The intervention in this study is one intra-articular knee injection of synthetic corticosteroid (kenalog) and variable amount of anesthetic,0.25% of bupivacaine. The patients will be randomized into this group.

Kenalog with bupivacaine Injection is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Kenalog for:

• Osteoarthritis
• Rheumatoid arthritis
• Bursitis
• Tendinitis
• Gouty arthritis

Approved in European Union as Kenalog for:

• Rheumatoid arthritis
• Osteoarthritis
• Bursitis
• Tendinitis
• Gouty arthritis

Approved in Canada as Kenalog for:

• Rheumatoid arthritis
• Osteoarthritis
• Bursitis
• Tendinitis
• Gouty arthritis

Who Is Running the Clinical Trial?

Foundation for Orthopaedic Research and Education

Lead Sponsor

Trials

16

Recruited

1,000+

Florida Orthopaedic Institute

Collaborator

Trials

9

Recruited

480+

Published Research Related to This Trial

In a study involving 84 patients with symptomatic knee osteoarthritis, a 10-mg dose of triamcinolone acetonide was found to be non-inferior to a 40-mg dose in reducing pain after 12 weeks, indicating that lower doses can be just as effective.

Both the 10-mg and 40-mg doses significantly improved pain and quality of life for patients, suggesting that lower doses may provide a safer option without compromising efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of intra-articular triamcinolone acetonide 10 mg vs. 40 mg in patients with knee osteoarthritis: a non-inferiority, randomized, controlled, double-blind, multicenter study. Utamawatin, K., Phruetthiphat, OA., Apinyankul, R., et al.[2023]

A 24-year-old woman experienced an immediate hypersensitivity reaction to intralesional triamcinolone acetonide after 10 years of successful treatment for keloid scars, highlighting that such reactions, while uncommon, can occur even after multiple prior injections without issues.

Allergy testing confirmed a positive reaction specifically to triamcinolone acetonide, indicating that IgE-mediated hypersensitivity should be considered in patients receiving repeated injections of this medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anaphylaxis following intralesional triamcinolone acetonide (Kenacort) injection. Laisuan, W., Wongsa, C., Dchapaphapeaktak, N., et al.[2020]

Intraarticular triamcinolone acetonide significantly reduced acute pain after arthroscopic knee surgery, with lower pain scores observed from 6 to 24 hours post-surgery compared to the saline control group.

Patients receiving triamcinolone required significantly less rescue analgesia, with none requesting additional pain relief compared to 53% in the saline group, highlighting its efficacy as a local pain management option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraarticular triamcinolone acetonide for pain control after arthroscopic knee surgery. Wang, JJ., Ho, ST., Lee, SC., et al.[2022]

The study found that combining 1% lidocaine or 0.25% bupivacaine with betamethasone sodium phosphate or betamethasone acetate significantly increased chondrotoxicity in human chondrocytes after 14 days, indicating potential harm to joint cartilage.

Methylprednisolone acetate and triamcinolone acetonide also showed significant chondrotoxic effects when used with 1% lidocaine, but not with 0.25% bupivacaine, suggesting that the choice of local anesthetic can influence the safety of corticosteroid injections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of local anesthetic and corticosteroid combinations on chondrocyte viability. Braun, HJ., Wilcox-Fogel, N., Kim, HJ., et al.[2021]

The study found that combining local anesthetics (lidocaine, ropivacaine, and bupivacaine) with the novel triamcinolone acetonide extended-release (TA-ER) formulation does not negatively affect its physical or chemical properties, ensuring its efficacy remains intact.

This compatibility suggests that in clinical practice, local anesthetics can be safely added to TA-ER injections for knee osteoarthritis pain without compromising the treatment's effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical and Chemical Compatibility of Extended-Release Triamcinolone Acetonide (TA-ER) with Common Local Anesthetics. Jackson, JD., Cotton, L., Turkington, M., et al.[2020]

In a randomized controlled trial involving 84 patients undergoing total knee arthroplasty (TKA), the addition of either high or low doses of corticosteroids to local anesthetic injections did not significantly reduce post-operative pain or improve range of motion.

The study suggests that peri-articular corticosteroids do not provide additional benefits in managing pain or recovery after TKA for patients with osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peri-articular steroid injection in total knee arthroplasty: a prospective, double blinded, randomized controlled trial. Chia, SK., Wernecke, GC., Harris, IA., et al.[2022]

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 randomized double-blind placebo-controlled trial involving 117 patients with knee osteoarthritis, Triamcinolone acetenoid injections provided significant pain relief at two and six weeks, with effects lasting up to twelve weeks, compared to placebo.

The study demonstrated that Triamcinolone not only alleviated pain but also significantly improved functional outcomes in patients, with no major complications reported, indicating it is a safe and effective treatment option for knee osteoarthritis in community health settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Outcome following Intra-articular Triamcinolone Injection in Osteoarthritic Knee at the Community: A Randomized Double Blind Placebo Controlled Trial. [2019]

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 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 involving 100 patients with knee osteoarthritis, both triamcinolone hexacetonide (TH) and methylprednisolone acetate (MA) injections significantly reduced pain at 4 weeks, with sustained improvements observed up to 24 weeks.

There was no significant difference in efficacy between TH and MA, as both treatments showed similar outcomes in pain relief and functional improvement, indicating that either corticosteroid can be effectively used for managing knee OA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Triamcinolone Hexacetonide versus Methylprednisolone Acetate Intraarticular Injections in Knee Osteoarthritis: A Randomized, Double-blinded, 24-week Study. Lomonte, AB., de Morais, MG., de Carvalho, LO., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7931012/

Intra-Articular Injections in Knee Osteoarthritis - PubMed Central Studies demonstrated that HA for knee OA was of greater benefit in those with less severe radiographic changes with the second course of HA [29] ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3171524/

Bupivacaine and Triamcinolone May Be Toxic To Human ... The combined used of triamcinolone and bupivacaine did not show additive chondrocyte death in any arm. Buffering of bupivacaine increased its chondrotoxicity.

3. aafp.org aafp.org/pubs/afp/issues/2008/1015/p971.html

Musculoskeletal Injections: A Review of the Evidence Intra-articular steroid injections reduce pain and swelling in osteoarthritis of the knee. A. The addition of local anesthetics to steroid ...

4. link.springer.com link.springer.com/article/10.1007/s12325-019-0878-2

Physical and Chemical Compatibility of Extended-Release ... These results demonstrate that lidocaine, bupivacaine, and ropivacaine are physically and chemically compatible with TA-ER.

5. ajronline.org ajronline.org/doi/10.2214/AJR.15.15132

Does Reducing the Concentration of Bupivacaine When ... Both bupivacaine 0.5% and bupivacaine 0.25% provide statistically significant and much improved pain relief 5–10 minutes and 1 week after intraarticular ...

6. 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 ...

7. withpower.com withpower.com/trial/phase-1-osteoarthritis-5-2023-1cc47

Corticosteroid + Anesthetic Injection for Knee Osteoarthritis The study demonstrated that Triamcinolone not only alleviated pain but also significantly improved functional outcomes in patients, with no major complications ...

8. mdpi.com mdpi.com/2411-5142/6/1/15

Intra-Articular Injections in Knee Osteoarthritis: A Review of ... The most frequently reported complications are pain and bleeding at the injection site, while septic arthritis is a rare major complication of intra-articular ...