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Use of Corticosteroid in Intraopertive Injections in Total Knee Replacement Surgery.

Study acronym: TKACSI
StatusRecruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Aug 31, 2026 → Aug 31, 2027
See other at-risk trials from Walter Reed National Military Medical Center

Record History

  1. Primary and study completion pushed from Aug 31, 2026 to Aug 31, 2027
    • Recruitment opened
    • Start date: Sep 1, 2025 to Sep 1, 2026
    • Site details revised
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT07151417
Lead Sponsor Walter Reed National Military Medical Center
Conditions
(from sponsor)		 Knee Osteoarthritis, Musculoskeletal Disease, Surgery
Related terms Musculoskeletal Diseases, Osteoarthritis, Knee
Enrollment 240 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov