Knee Injections for Knee Arthritis

Overseen By Jeffrey P Nadwodny, DO

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Mayo Clinic

Disqualifiers: Diabetes, Physical therapy, 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

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

40 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications, but it does mention that no other treatment is allowed during the study. It's best to discuss your specific medications with the trial coordinators.

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

Research shows that Triamcinolone Acetonide injections can significantly reduce knee pain and improve function in people with knee osteoarthritis for up to 12 weeks. Additionally, an extended-release form of the drug has been shown to provide longer-lasting pain relief and improved physical function compared to a placebo. ^{1 2 3 4 5}

Is Triamcinolone Acetonide safe for knee arthritis treatment?

Triamcinolone Acetonide, used for knee arthritis, is generally well tolerated and has a safety profile similar to placebo, with reduced risk of systemic side effects like blood sugar spikes. Studies show it does not harm joint cartilage and is safe for repeat use. ^{2 3 6 7 8}

How is the drug Triamcinolone Acetonide unique for treating knee arthritis?

Triamcinolone Acetonide is unique because it is available in an extended-release form that slowly releases the medication in the knee joint, providing longer-lasting pain relief and reducing the risk of side effects like blood sugar spikes. This extended-release formulation allows for a single injection to manage pain effectively over a longer period compared to traditional corticosteroid injections. ^{2 3 4 9 10}

What is the purpose of this trial?

The purpose of this study is to assess obese patients with knee arthritis and determine the non-inferiority of a low dose steroid treatment vs. standard dose steroid treatment for two knee outcome measures: pain and function.

Research Team

Jeffrey P Nadwodny, DO

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for obese individuals with knee arthritis who are seeking treatment options. The study aims to include those who can safely receive steroid injections and have not had prior knee injections within a certain timeframe.

Inclusion Criteria

I am overweight and have knee arthritis confirmed by X-ray, seeking a steroid injection.

Exclusion Criteria

My diabetes is not under control, with an A1c over 8%.

BMI < 30 kg/m2

No other treatment within the time frame of the study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intra-articular corticosteroid injections with either a low dose or standard dose

12 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Triamcinolone Acetonide

Trial Overview The study is testing two doses of Triamcinolone Acetonide, a steroid: one group receives a low dose, while the other gets the standard dose. Researchers want to see if the lower dose works just as well for pain relief and improved knee function.

Participant Groups

Group I: Lower Dose Group Experimental Treatment 1 Intervention

Patients with knee osteoarthritis who are interested in knee intra-articular corticosteroid injections and meet the inclusion criteria.

Group II: Standard Dose Group Active Control 1 Intervention

Patients with knee osteoarthritis who are interested in knee intra-articular corticosteroid injections and meet the inclusion criteria.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Findings from Research

A single injection of triamcinolone hexacetonide (THA) significantly improved patient-reported outcomes and pain relief in knee osteoarthritis (OA) patients, with 78% reporting improvement at week 1 compared to 49% in the placebo group.

The effectiveness of THA was particularly enhanced in patients with joint effusion and those who had synovial fluid aspirated during the injection, indicating that these factors may influence treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intra-articular triamcinolone hexacetonide in knee osteoarthritis: factors influencing the clinical response. Gaffney, K., Ledingham, J., Perry, JD.[2022]

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]

Triamcinolone acetonide extended-release (ER) 32 mg significantly reduces knee osteoarthritis pain over 24 weeks compared to placebo, while also improving stiffness and physical function, demonstrating its efficacy as a treatment option.

The formulation of triamcinolone acetonide ER in PLGA microspheres allows for prolonged release in the joint, minimizing systemic exposure and related side effects, making it a safer alternative to traditional corticosteroid injections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Triamcinolone Acetonide Extended-Release: A Review in Osteoarthritis Pain of the Knee. Paik, J., Duggan, ST., Keam, SJ.[2023]

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]

In a double-blind study involving 30 patients with rheumatoid arthritis, all three intra-articular steroid preparations (prednisolone t-butyl acetate, methyl prednisolone acetate, and triamcinolone hexacetonide) showed thermographic improvement in knee synovitis, with triamcinolone demonstrating the greatest and longest-lasting effect.

Despite the local improvements in knee symptoms, no significant overall systemic improvement was observed after a single injection of any steroid, although all three preparations suppressed the body's natural cortisol production.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A thermographic and clinical comparison of three intra-articular steroid preparations in rheumatoid arthritis. Bird, HA., Ring, EF., Bacon, PA.[2022]

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 phase IIa study involving 24 patients with bilateral knee osteoarthritis, the intra-articular injection of triamcinolone acetonide extended release (TA-ER) was well tolerated and showed a lower peak plasma concentration of the drug compared to traditional triamcinolone acetonide crystalline suspension (TAcs).

The study demonstrated that TA-ER resulted in lower systemic exposure to triamcinolone acetonide after bilateral injections, suggesting it may be a safer option for patients needing simultaneous treatment in both knees.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, phase IIa study to assess the systemic exposure of triamcinolone acetonide following injection of extended-release triamcinolone acetonide or traditional triamcinolone acetonide into both knees of patients with bilateral knee osteoarthritis. Kivitz, A., Kwong, L., Shlotzhauer, T., et al.[2022]

In a phase 3b study involving 208 patients with knee osteoarthritis, repeat injections of triamcinolone acetonide extended-release (TA-ER) were found to be safe and well tolerated, with no unexpected adverse events or significant changes in knee radiographs after 52 weeks.

Both the first and second injections of TA-ER provided similar and substantial pain relief, with most patients experiencing at least a 50% reduction in pain, indicating effective symptom management across varying severities of osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Repeat Administration of Triamcinolone Acetonide Extended-release in Osteoarthritis of the Knee: A Phase 3b, Open-label Study. Spitzer, AI., Richmond, JC., Kraus, VB., et al.[2020]

In a study of 60 children under 10 with pauci-articular juvenile chronic arthritis, 77% of treated knees showed excellent or good outcomes one year after receiving local injections of triamcinolone hexacetonide.

The treatment was effective in controlling disease activity, with only minor complications reported, such as small areas of subcutaneous tissue atrophy in 2 patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Triamcinolone into the knee joint in juvenile chronic arthritis. Earley, A., Cuttica, RJ., McCullough, C., et al.[2017]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Intra-articular triamcinolone hexacetonide in knee osteoarthritis: factors influencing the clinical response. [2022]

2. Nepal 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]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Triamcinolone Acetonide Extended-Release: A Review in Osteoarthritis Pain of the Knee. [2023]

4. Canada pubmed.ncbi.nlm.nih.gov

Efficacy of Triamcinolone Hexacetonide versus Methylprednisolone Acetate Intraarticular Injections in Knee Osteoarthritis: A Randomized, Double-blinded, 24-week Study. [2022]

5. England pubmed.ncbi.nlm.nih.gov

A thermographic and clinical comparison of three intra-articular steroid preparations in rheumatoid arthritis. [2022]

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

Physical and Chemical Compatibility of Extended-Release Triamcinolone Acetonide (TA-ER) with Common Local Anesthetics. [2020]

7. England pubmed.ncbi.nlm.nih.gov

A randomized, phase IIa study to assess the systemic exposure of triamcinolone acetonide following injection of extended-release triamcinolone acetonide or traditional triamcinolone acetonide into both knees of patients with bilateral knee osteoarthritis. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Repeat Administration of Triamcinolone Acetonide Extended-release in Osteoarthritis of the Knee: A Phase 3b, Open-label Study. [2020]

9. Italy pubmed.ncbi.nlm.nih.gov

Triamcinolone into the knee joint in juvenile chronic arthritis. [2017]

10. England 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. [2023]