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NCT05097976 · ClinicalTrials.gov registry record · Phase 4
Medrol Dosepak for Outpatient Total Knee Arthroplasty
A Phase 4 study of Total Knee Arthroplasty, sponsored by Rush University Medical Center.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 420
- Enrollment target
- 1
- Study location
NCT05097976 is a Phase 4 study of Total Knee Arthroplasty that is actively recruiting participants, run by Rush University Medical Center. The registered enrollment target is 420 participants, above the 280-participant average among 29 other Total Knee Arthroplasty trials with a reported enrollment target (50% higher). The trial reports 1 study location across 1 state.
The verdict
NCT05097976, a Phase 4 study of Total Knee Arthroplasty, is actively recruiting participants, sponsored by Rush University Medical Center.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 420 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to evaluate the efficacy of an oral methylprednisolone taper on acute postoperative pain, function, opioid consumption, nausea, and complications following outpatient total knee arthroplasty (TKA). We hypothesize that administration of an oral methylprednisolone taper starting on postoperative day 1 (POD 1) following TKA will be associated with improved pain and decreased opioid use, nausea, and complications at POD1-7, as compared to similar patients who receive placebo. Additionally, those taking methylprednisolone will report decreased pain and greater objective functional outcomes at 3 and 6 weeks postoperatively as compared to controls.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Methylprednisolone
Study Locations (1)
Illinois
- Rush Oak Brook Outpatient Center - Oak Brook
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 420 participants |
| Start Date | 2022-03-01 |
| Est. Completion | 2026-12 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05097976
The ClinicalTrials.gov registry entry for NCT05097976 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 420 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 280-participant average among 29 other Total Knee Arthroplasty trials with a reported enrollment target (50% higher). The listed sponsor is Rush University Medical Center, which has 320 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Total Knee Arthroplasty appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05097976 reports 1 study location spanning 1 distinct geographic area - top geographies include Illinois.
Frequently Asked Questions
What is clinical trial NCT05097976 about?
NCT05097976 is a clinical study titled "Medrol Dosepak for Outpatient Total Knee Arthroplasty". The purpose of this study is to evaluate the efficacy of an oral methylprednisolone taper on acute postoperative pain, function, opioid consumption, nausea, and complications following outpatient total knee arthroplasty (TKA). We hypothesize that administration of an oral methylprednisolone taper st...
What is the current status of trial NCT05097976?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 420 participants. The study started on 2022-03-01. Estimated completion is 2026-12.
What conditions does trial NCT05097976 study?
This clinical trial studies the following conditions: Total Knee Arthroplasty.
What interventions are being tested in trial NCT05097976?
The interventions under investigation include: Placebo (DRUG), Methylprednisolone (DRUG).
Who is sponsoring clinical trial NCT05097976?
This trial is sponsored by Rush University Medical Center, which has 320 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05097976 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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