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NCT07605923 · ClinicalTrials.gov registry record · Phase 4
Methylprednisolone Addition to Multimodal Pain Regimens After Anterior Cruciate Ligament Reconstruction
A Phase 4 study, sponsored by University of Alabama at Birmingham.
- Not yet
- Registry status
- Phase 4
- Development phase
- 64
- Enrollment target
NCT07605923 is a Phase 4 study that has not yet begun recruiting, run by University of Alabama at Birmingham. The registered enrollment target is 64 participants.
The verdict
NCT07605923, a Phase 4 study, has not yet begun recruiting, sponsored by University of Alabama at Birmingham.
- NOT YET RECRUITING
- Registry status
- Phase 4
- Development phase
- 64 participants
- Enrollment target
Study Summary
Patients who are being seen for ACL tears will be approached in the UAB Orthopedic Clinic. Included patients will be those aged 14-65 undergoing ACL Reconstruction. Excluded patients will be those with contraindications to corticosteroids. If the patient meets the criteria and agrees to participate, then the consent form will be signed, and the patient will be enrolled. Enrolled patients will be randomized to one of two groups. Patients in the treatment group will receive a 4 mg oral 6-day methylprednisolone taper in addition to standard post-operative pain control. Patients in the control group will receive standard post-operative pain control. All patients will receive the surgeon's standard ACL postoperative multimodal pain regimen. Endpoints will include narcotic consumption assessed daily and at one week post-op through a patient self-reported diary. The VAS pain score will be collected each day for the first week. Secondary endpoints will include range of motion and patient-reported outcomes, including IKDC, KOOS Jr, Tegner Activity Scale, ACL-RSI, and PROMIS Global collected at baseline, 2 weeks, 6 weeks and 3 months. All outcomes will be collected through PatientIQ.
Interventions
- DRUG Methyl Prednisolone (MP)
- DRUG Standard Post-Operative Pain Control
- COMBINATION_PRODUCT Surgeon's Standard ACL Postoperative Regimen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2026-09 |
| Est. Completion | 2031-08 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07605923
The ClinicalTrials.gov registry entry for NCT07605923 describes a study currently listed as not yet recruiting, categorized as Phase 4. The registered enrollment target is 64 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Methyl Prednisolone (MP) is the first listed.
NCT07605923 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07605923 about?
NCT07605923 is a clinical study titled "Methylprednisolone Addition to Multimodal Pain Regimens After Anterior Cruciate Ligament Reconstruction". Patients who are being seen for ACL tears will be approached in the UAB Orthopedic Clinic. Included patients will be those aged 14-65 undergoing ACL Reconstruction. Excluded patients will be those with contraindications to corticosteroids. If the patient meets the criteria and agrees to participate,...
What is the current status of trial NCT07605923?
This trial is currently not yet recruiting. It is a Phase 4 study. The enrollment target is 64 participants. The study started on 2026-09. Estimated completion is 2031-08.
What interventions are being tested in trial NCT07605923?
The interventions under investigation include: Methyl Prednisolone (MP) (DRUG), Standard Post-Operative Pain Control (DRUG), Surgeon's Standard ACL Postoperative Regimen (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT07605923?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
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