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Adjunctive Use of Corticosteroid in Periarticular Injections in Primary Total Knee Arthroplasty

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY

The goal of this clinical trial is to find out which type of steroid medicine, when added to a standard pain-control injection during total knee replacement surgery, works best at reducing pain, limiting opioid use, and improving recovery in adults undergoing surgery for severe knee arthritis or injury. The main questions it aims to answer are: Does adding a steroid to the injection improve pain control and reduce opioid use after surgery? Is the newer extended-release steroid (Zilretta) more effective and safer-especially for patients with diabetes-than the traditional steroid (methylprednisolone)? Researchers will compare: Standard pain-control injection alone Standard injection plus methylprednisolone Standard injection plus Zilretta to see which option provides better pain relief, less opioid use, and improved knee function. (Patients with diabetes or prediabetes will only be in the standard injection or Zilretta groups so researchers can study whether Zilretta is safer for blood sugar control.) Participants will: Be randomly assigned to one of the study groups during their total knee replacement surgery Receive the assigned pain-control injection around the knee joint Be followed after surgery to measure: Pain levels Opioid pain medication use Knee movement (range of motion) Whether another procedure (such as manipulation under anesthesia) is needed if the knee becomes too stiff Patient-reported outcome surveys about pain and function

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Maryland
Walter Reed National Military Medical Center
RECRUITING
Bethesda
Contact Information
Primary
John P Cody, MD
john.p.cody3.mil@health.mil
301-538-2472
Backup
Ian P Marshall, MD
ian.p.marshall.mil@health.mil
585-576-7864
Time Frame
Start Date: 2026-09-01
Estimated Completion Date: 2027-08-31
Participants
Target number of participants: 240
Treatments
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)
Sponsors
Leads: Walter Reed National Military Medical Center

This content was sourced from clinicaltrials.gov