Clinical Trial Finder

Inclusion Criteria:

• - 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.

• - Age 18 or older.

• - successful surgical intervention.

Exclusion Criteria:

• - Unicompartmental knee arthroplasty (UKA) - Revision total knee arthroplasty (rTKA) - Females who are pregnant or nursing.

• - Allergic to ingredients in PAI or previous adverse reaction to steroids being used in this study.

- Diabetics will be excluded from Group 2 (standard PAI + methylprednisolone)

Total knee replacement surgery (also called total knee arthroplasty, or TKA) is a common procedure for people with severe knee arthritis or injury. While the surgery often leads to significant pain relief and improved mobility, the days and weeks afterward can be uncomfortable. Managing pain during recovery is important-not just to make patients feel better, but also to help them move their knee sooner, avoid excessive use of opioid medications, and get back to normal activities faster. One common pain management tool is called a pericapsular injection (PAI). This is a mixture of medications injected around the knee joint during surgery to help control pain after the operation. PAIs usually include a long-lasting numbing medicine, an anti-inflammatory drug, and sometimes other medications that improve pain relief. Corticosteroids-powerful anti-inflammatory drugs-are sometimes added, but the best type of steroid and the ideal way to give it is still debated among doctors. Why This Study Is Being Done This study will compare two types of corticosteroids, methylprednisolone (a traditional steroid) and Zilretta (a newer, extended-release form of the steroid triamcinolone), to see which works better when added to the standard PAI. Zilretta releases medication slowly over time, which may lead to longer-lasting pain control and fewer side effects such as temporary increases in blood sugar-something especially important for people with diabetes. How the Study Works.Patients having total knee replacement will be randomly placed into one of three groups: 1. Standard PAI only

• - This mixture includes a long-acting numbing medicine, an anti-inflammatory (ketorolac), a small dose of adrenaline (epinephrine), clonidine (to help with pain control), and sterile saline.

2. Standard PAI + methylprednisolone

• - The same standard mixture with the addition of 40 mg of methylprednisolone.

3. Standard PAI + Zilretta

• - The same standard mixture with 32 mg of Zilretta, the extended-release steroid.

People with diabetes or prediabetes will only be placed in groups 1 or 3 so researchers can compare how Zilretta affects them compared to no steroid at all. What Will Be Measured.The researchers will check patients' progress at several points after surgery to investigate:

• - Pain levels.

• - Opioid pain medication use (measured in morphine-equivalent doses) - Knee movement (range of motion) - Need for further procedures (such as manipulation under anesthesia, or MUA, if the knee becomes too stiff) - Patient-reported outcome surveys (including the Knee Injury and Osteoarthritis Outcome Score and the Single Assessment Numeric Evaluation) Expected Findings.

The team believes that adding a corticosteroid to the PAI will:

• - Improve pain control.

• - Reduce the need for opioid medications.

• - Lower the risk of needing a manipulation procedure to improve range of motion They also expect that Zilretta, because it lasts longer, will work better than methylprednisolone-especially in people with diabetes, by offering pain relief without causing as much temporary increase in blood sugar.

Why This Matters Past research shows that PAIs can help reduce pain and the need for opioids after knee replacement surgery, without raising the risk of infection or other serious complications. But doctors still don't know which steroid is best to use. If Zilretta works better and causes fewer side effects, it could become the preferred option for many patients-particularly those with other health issues like diabetes. The results of this study could help guide surgeons toward the safest and most effective pain control strategies for people recovering from knee replacement surgery, ultimately leading to better recoveries, fewer complications, and improved quality of life.

Arms

Active Comparator: Standard PAI

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

Active Comparator: Methylprednisolone

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

Active Comparator: Zilretta

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

Interventions

Drug: - PAI

Standard PAI: 30 mg Toradol/ketorolac (30mg/ml), 49.25ml 0.5% ropivacaine (5mg/ml), and 0.5 mg

Drug: - PAI + steroid

Standard PAI + 40mg methylprednisolone (n = 40)

Drug: - PAI + zilretta

Standard PAI + 32mg Zilretta (triamcinolone acetonide extended release injectable suspension)