Corticosteroid Injections for Osteoarthritis

(TKACSI Trial)

Overseen By Ian P Marshall, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Walter Reed National Military Medical Center

Disqualifiers: Unicompartmental knee arthroplasty, Pregnancy, 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: 53

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to determine which steroid best reduces pain and opioid use for individuals undergoing knee replacement surgery due to severe arthritis or injury. Researchers are evaluating whether adding a steroid to the pain-control injection enhances recovery and if the newer steroid, Zilretta (a type of corticosteroid), is safer and more effective, particularly for those with diabetes. Participants will receive either the standard injection alone or the standard injection with methylprednisolone or Zilretta. This trial suits adults scheduled for knee replacement surgery at specific military medical centers. As a Phase 2, Phase 3 trial, the research measures the treatment's effectiveness in an initial, smaller group and represents the final step before FDA approval, allowing participants to contribute to advancements in knee surgery pain management.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Research has shown that both methylprednisolone and Zilretta are generally safe and well-tolerated when injected into the knee. Studies have found that methylprednisolone effectively reduces pain and improves movement in people with knee osteoarthritis, making it a reliable option for managing knee pain.

Zilretta, a long-acting form of the steroid triamcinolone, also has a good safety record. Research suggests it is well tolerated and does not harm knee cartilage. Its extended-release formula releases the medication slowly, prolonging its effect and reducing high levels in the body.

Both treatments have been used in medical settings and are supported by safety data. However, discussing any concerns with a healthcare provider before joining a clinical trial is important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for osteoarthritis because they offer innovative approaches to managing the condition. The use of Zilretta, an extended-release formulation of triamcinolone acetonide, stands out because it potentially provides longer-lasting relief with fewer injections compared to standard corticosteroid treatments. Meanwhile, adding methylprednisolone to the standard anesthetic mix could enhance pain relief effectiveness, offering a more targeted approach for non-diabetic patients. These methods aim to improve the duration and quality of pain relief, which could significantly enhance the quality of life for those suffering from osteoarthritis.

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

This trial will compare different corticosteroid injection treatments for osteoarthritis. Research has shown that methylprednisolone injections, one of the treatments in this trial, effectively reduce pain and improve movement in people with knee osteoarthritis. Studies have found that it works similarly to other treatments, such as hyaluronic acid, in easing pain. Another treatment option in this trial is Zilretta, a long-lasting steroid, which has proven to provide quick and extended pain relief for knee osteoarthritis. It can improve movement and offers longer-lasting relief, especially for those who haven't found relief with other treatments. Both treatments show promising results, but Zilretta might offer longer-lasting benefits. ^{1 2 3 4 5}

Who Is on the Research Team?

John P Cody, MD

Principal Investigator

Walter Reed National Military Medical Center

Are You a Good Fit for This Trial?

Adults undergoing total knee replacement due to severe arthritis or injury can join this trial. It's not for patients with diabetes or prediabetes, who will only be considered for certain study groups to assess blood sugar control safety.

Inclusion Criteria

I have had a successful surgery.

I am 18 years old or older.

Patients within the MHS who are DEERS eligible undergoing primary TKA at Walter Reed National Military Medical Center (WRNMMC), Surgery Center of Chevy Chase or District Surgery Center

Exclusion Criteria

I am scheduled for or have had a revision knee replacement.

I am diabetic and cannot join Group 2 of the study.

I have had a partial knee replacement.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo total knee replacement surgery and receive assigned pain-control injection

1 day

1 visit (in-person)

Postoperative Monitoring

Participants' pain levels, opioid use, and knee movement are monitored

4 weeks

Multiple phone calls at 24 hours, 72 hours, 7 days, and 28 days

Follow-up

Participants are monitored for long-term outcomes including range of motion and patient-reported outcomes

12 months

Visits at 28 days, 120 days, and 365 days

What Are the Treatments Tested in This Trial?

Interventions

• Corticosteroid

Trial Overview The trial is testing if adding steroids to standard pain-control injections during knee surgery helps with pain, reduces opioid use, and improves recovery. It compares no steroid, traditional methylprednisolone, and extended-release Zilretta in the injection.

How Is the Trial Designed?

Group I: Standard PAI Active Control 1 Intervention

Group1 (n=80; 40 non-diabetic and 40 diabetic participants): Standard PAI: 30 mg Toradol/ketorolac (30mg/ml), 49.25ml 0.5% ropivacaine (5mg/ml), and 0.5 mg epinephrine (1mg/ml), 0.8 ml clonidine (0.1mg/ml) and 8.45 ml 0.9% sodium chloride

Group II: Methylprednisolone Active Control 1 Intervention

2\. Group2 (n=40, non-diabetic): Standard PAI + 40mg methylprednisolone (n = 40)

Group III: Zilretta Active Control 1 Intervention

3\. Group3 (n=80; 40 non-diabetic and 40 diabetic participants): Standard PAI + 32mg Zilretta (triamcinolone acetonide extended release injectable suspension)

Who Is Running the Clinical Trial?

Walter Reed National Military Medical Center

Lead Sponsor

Trials

149

Recruited

33,800+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5908555/

Intra-articular injection of methylprednisolone for reducing ... Intra-articular methylprednisolone injection was associated with an improved pain relief and physical function in patients with knee osteoarthritis.

2. sciencedirect.com sciencedirect.com/science/article/pii/S1743919118306265

Review Comparison of intra-articular hyaluronic acid and ... The present meta-analysis indicated that both HA and methylprednisolone were effective in reducing pain in knee OA and HA showed comparable effect to ...

3. journals.lww.com journals.lww.com/md-journal/fulltext/2018/04130/intra_articular_injection_of_methylprednisolone.8.aspx

Intra-articular injection of methylprednisolone for... : Medicine Intra-articular methylprednisolone injection was associated with an improved pain relief and physical function in patients with knee osteoarthritis.

4. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06163755

Comparison of Efficacy of Intra-articular Morphine vs ... Comparison of Efficacy of Intra-articular Morphine vs Methylprednisolone in Patients With Knee Osteoarthritis. A Single - Blind, Randomized-controlled Study.

5. academic.oup.com academic.oup.com/rheumap/article/8/4/rkae136/7874980

Intramuscular methylprednisolone in hand osteoarthritis In this retrospective study, more than half of hand OA patients displayed good response to intramuscular MP administration.