Corticosteroids in Total Knee Replacement Surgery
This study is looking at how different steroid medications, when added to a standard pain injection during total knee replacement surgery, affect pain, opioid use, and recovery. Researchers want to see if adding either methylprednisolone or Zilretta (an extended-release steroid) to the standard injection works better than the standard injection alone. They also want to compare Zilretta to methylprednisolone, especially for patients with diabetes. The study will measure pain, range of motion, and patient-reported outcomes for up to a year after surgery. You may be able to join if you are 18 or older, having a primary total knee replacement at specific military or affiliated surgery centers, and meet other criteria. The study aims to enroll 240 participants, but its current status is unclear.
- Study design
- This is an interventional study with 240 planned participants. It compares three different drug interventions: a standard pain injection (PAI), PAI plus methylprednisolone, and PAI plus Zilretta.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- You would be followed for 24 hours, 72 hours, 7 days, 28 days, 120 days, and 365 days after surgery to assess outcomes.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Use of Corticosteroid in Intraopertive Injections in Total Knee Replacement Surgery.
At a glance
Conditions
NCT07151417
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Walter Reed National Military Medical Center
Bethesda, Marylandstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- John P Cody, MD · PRINCIPAL_INVESTIGATOR · Walter Reed National Military Medical Center
Who to contact
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Inclusion
Exclusion
What this trial measures
- The primary outcome is to determine whether total knee arthroplasty outcomes are significantly better for Zilretta (Group 3) and methylprednisolone (Group 2) as compared to standard PAI (Group 1) and Zilretta versus methylprednisolone.24 hours, 72 hours, 7 days, and 28 days post
The following outcomes after total knee arthroplasty will be compared to determine whether outcomes are significantly better for Zilretta (Group 3) and methylprednisolone (Group 2) as compared to standard PAI (Group 1) and Zilretta versus methylprednisolone: • Improvement in pain levels postoperatively based on measurement of pain intensity using a Visual Analogue Scale (VAS) at 24hrs, 72 hours, and 7 days (all phone call), and 28 days
- Postoperative ROM28, 120 and 365 days postop
The following outcomes after total knee arthroplasty will be compared to determine whether outcomes are significantly better for Zilretta (Group 3) and methylprednisolone (Group 2) as compared to standard PAI (Group 1) and Zilretta versus methylprednisolone: Change in range of motion (ROM) at 28, 120 and 365 days postop
- Patient reported outcome measure120 and 365 days postoperatively
The following outcomes after total knee arthroplasty will be compared to determine whether outcomes are significantly better for Zilretta (Group 3) and methylprednisolone (Group 2) as compared to standard PAI (Group 1) and Zilretta versus methylprednisolone: • Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) score at 120 and 365 days postoperatively
- Patient reported outcome measures 2120 and 365 days postop
The following outcomes after total knee arthroplasty will be compared to determine whether outcomes are significantly better for Zilretta (Group 3) and methylprednisolone (Group 2) as compared to standard PAI (Group 1) and Zilretta versus methylprednisolone: • Change in Single Assessment Numeric Evaluation (SANE) score at 120 and 365 days postop
- Postop pain medication usage24hrs, 72 hours, and 7 days, and 28 days postop
The following outcomes after total knee arthroplasty will be compared to determine whether outcomes are significantly better for Zilretta (Group 3) and methylprednisolone (Group 2) as compared to standard PAI (Group 1) and Zilretta versus methylprednisolone: • Decreased morphine equivalent (MEQ) postoperatively at 24hrs, 72 hours, and 7 days (all phone call), and 28 days
- MUA rate28 days postop
The following outcome after total knee arthroplasty will be compared to determine whether outcomes are significantly better for Zilretta (Group 3) and methylprednisolone (Group 2) as compared to standard PAI (Group 1) and Zilretta versus methylprednisolone: • Decreased manipulation under anesthesia rates (MUA) compared to historical rate at our institution at 28 days