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NCT05859269 · ClinicalTrials.gov registry record · Phase 4
Methylprednisolone Taper After Total Knee Replacement
A Phase 4 study of Knee Arthritis, sponsored by Emory University.
- Completed
- Registry status
- Phase 4
- Development phase
- 101
- Enrollment target
- 2
- Study locations
NCT05859269: Completed Phase 4 study of Knee Arthritis, sponsored by Emory University.
NCT05859269 is a Phase 4 study of Knee Arthritis that has completed, run by Emory University. The registered enrollment target is 101 participants, below the 126-participant average among 7 other Knee Arthritis trials with a reported enrollment target (20% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05859269, a Phase 4 study of Knee Arthritis, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 101 participants
- Enrollment target
- 2
- Study locations
Study Summary
Total knee replacement surgery is a commonly performed and widely successful surgery to improve mobility and decrease pain in patients suffering from severe knee arthritis. However, in the immediate period after knee replacement, patients often experience significant pain and nausea, which can limit early recovery after surgery. Glucocorticoids are anti-inflammatory drugs that can reduce pain and swelling by blocking the inflammatory process, and have already shown promise in various surgical settings, including after knee replacement. There are different glucocorticoid formulations available, and in this particular study, we are evaluating the effects of administering a Medrol Dose Pak, which is a commonly available glucocorticoid taper that is administered over a short period of time after surgery. Our hypothesis is that the administration of the Medrol Dose Pak will lead to decreased pain, nausea, and opioid consumption in the weeks following total knee replacement.
Primary Outcome
A pain assessment will be assessed at each post-operative visit via the Visual Analog Pain Scale (VAS-pain), which is ranked from 0 (no pain) to 10 (highest amount of pain). Pain will be assessed at rest and during active movement of extremity. Patients will also be asked to fill out the VAS-pain score each day until post-op day 7.
Conditions Studied
Interventions
- OTHER Standard of Care
- DRUG Methylprednisolone
Study Locations (2)
Georgia
- Emory Musculoskeletal Institute - Atlanta
- Emory University Orthopaedics & Spine Hospital - Tucker
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 101 participants |
| Start Date | 2023-10-16 |
| Est. Completion | 2025-07-23 |
| Phase | Phase 4 |
What the finished NCT05859269 record still lists
NCT05859269 is an interventional study that assigns participants to a tested intervention. The registered 101 participants enrollment target is mid-sized for trials with a published cap, below the 126-participant average among 7 other Knee Arthritis trials with a reported enrollment target (20% lower).
The record links to 1 condition, with Knee Arthritis appearing as the primary indexed condition, and to 2 interventions - of which Standard of Care is the first listed.
NCT05859269 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT05859269 about?
NCT05859269 is a clinical study titled "Methylprednisolone Taper After Total Knee Replacement". Total knee replacement surgery is a commonly performed and widely successful surgery to improve mobility and decrease pain in patients suffering from severe knee arthritis. However, in the immediate period after knee replacement, patients often experience significant pain and nausea, which can limit...
What is the current status of trial NCT05859269?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 101 participants. The study started on 2023-10-16. Estimated completion is 2025-07-23.
What conditions does trial NCT05859269 study?
This clinical trial studies the following conditions: Knee Arthritis.
What interventions are being tested in trial NCT05859269?
The interventions under investigation include: Standard of Care (OTHER), Methylprednisolone (DRUG).
Who is sponsoring clinical trial NCT05859269?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05859269 being conducted?
This trial has 2 study locations across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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