NCT07151417 Use of Corticosteroid in Intraopertive Injections in Total Knee Replacement Surgery.
| NCT ID | NCT07151417 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Walter Reed National Military Medical Center |
| Condition | Knee Osteoarthritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 240 participants |
| Start Date | 2026-09-01 |
| Primary Completion | 2027-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 240 participants in total. It began in 2026-09-01 with a primary completion date of 2027-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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)
Contact & Investigator
John P Cody, MD
PRINCIPAL INVESTIGATOR
Walter Reed National Military Medical Center
Frequently Asked Questions
Who can join the NCT07151417 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Knee Osteoarthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07151417 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07151417 currently recruiting?
Yes, NCT07151417 is actively recruiting participants. Contact the research team at john.p.cody3.mil@health.mil for enrollment information.
Where is the NCT07151417 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT07151417 clinical trial?
NCT07151417 is sponsored by Walter Reed National Military Medical Center. The principal investigator is John P Cody, MD at Walter Reed National Military Medical Center. The trial plans to enroll 240 participants.