ACL ReconstructionPhase 4NCT07605923
Methylprednisolone Addition to Multimodal Pain Regimens After Anterior Cruciate Ligament Reconstruction
A Phase 4 study testing Methyl Prednisolone (MP) and Surgeon's Standard ACL Postoperative Regimen in people with ACL Reconstruction, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 65 years
- Conditions the study is for
- ACL Reconstruction
- What is being tested?
- Methyl Prednisolone (MP) and Surgeon's Standard ACL Postoperative Regimen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Aug 2031
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- aged 14-65
- undergoing ACL Reconstruction.
Who cannot join
- contraindications to corticosteroids
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Amit Momaya, MD, (205) 930-8339, amomaya@uabmc.edu
Crystal Taylor, (205) 807-4050, crystalmtaylor@uabmc.edu
About this study
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.
- Conditions
- ACL Reconstruction
- Being tested
- Methyl Prednisolone (MP), Standard Post-Operative Pain Control, Surgeon's Standard ACL Postoperative Regimen
- Keywords
- ACL, Anterior Cruciate ligament reconstruction, postoperative pain, corticosteroid taper, methylprednisolone taper, multimodal pain protocol
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methyl Prednisolone (MP)Drug
Also called Corticosteroid
Participants will receive 4mg oral tablet of methylprednisolone taper for 6 days after surgery.
Standard Post-Operative Pain ControlDrug
All patients will receive the surgeon's standard ACL postoperative multimodal pain regimen.
Surgeon's Standard ACL Postoperative RegimenCombination product
All patients will receive the surgeon's standard ACL postoperative multimodal pain regimen.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Patients in the treatment group will receive a 4 mg oral 6-day methylprednisolone taper in addition to standard post-operative pain control. All patients will receive the surgeon's standard ACL postoperative multimodal pain regimen. Receives: Drug: Methyl Prednisolone (MP); Combination Product: Surgeon's Standard ACL Postoperative Regimen |
| Control Group | Active comparator | 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. Receives: Drug: Standard Post-Operative Pain Control; Combination Product: Surgeon's Standard ACL Postoperative Regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Narcotic Consumption Post Surgery
Paricipants will be assessed on the average amount of pain medication taken on a daily basis.
Measured: Daily up to 6 days and 1 week post op
Percentage of overall Pain Post Operatively
Participants will be evaluated using the Visual Analogue Scale (VAS) for pain is a self-reported tool, typically a 10-cm horizontal line, anchored by "no pain" (0 cm) and "worst pain" (10 cm). Patients mark their pain level, offering a simple, sensitive, and highly subjective assessment for acute, chronic, or disease-specific pain.
Measured: Daily for 7 days post op
Secondary outcomes (1)
Change in Range of Motion
Participants will be measured on their range of motion after surgery using a goniometer. An instrument used to measure joint angles (range of motion) in rehabilitation and physical therapy, or to determine precise angular positions in engineering and physics.
Measured: baseline, 2 weeks, 6 weeks and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study startSep 2026 (estimated)
- Primary completionAug 2031 (estimated)
- Study completionAug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ACL ReconstructionStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amit Momaya, University of Alabama at Birmingham
- Investigators
- Amit Momaya, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07605923
- Sponsor's protocol ID
- IRB-300016646
- Other IDs
- UAB
- Status last verified
- May 2026
- First submitted
- 18 May 2026
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wagner ER, Hussain ZB, Karzon AL, Cooke HL, Toston RJ, Hurt JT, Dawes AM, Gottschalk MB. Methylprednisolone taper is an effective addition to multimodal pain regimens after total shoulder arthroplasty: results of a randomized controlled trial: 2022 Neer Award winner. J Shoulder Elbow Surg. 2024 May;33(5):985-993. doi: 10.1016/j.jse.2023.12.016. Epub 2024 Feb 4.
PubMed 38316236
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methylprednisolone Addition to Multimodal Pain Regimens After Anterior Cruciate Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT07605923
- Acronym / sponsor ID
- IRB-300016646
- Conditions
- ACL Reconstruction
- Keywords
- ACL, Anterior Cruciate ligament reconstruction, postoperative pain, corticosteroid taper, methylprednisolone taper, multimodal pain protocol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Aug 2031 (estimated)
- Study completion
- Aug 2031 (estimated)
- First posted
- 26 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Drug: Methyl Prednisolone (MP), Combination Product: Surgeon's Standard ACL Postoperative RegimenPatients in the treatment group will receive a 4 mg oral 6-day methylprednisolone taper in addition to standard post-operative pain control. All patients will receive the surgeon's standard ACL postoperative multimodal pain regimen. |
| Control Group | Active comparator | Drug: Standard Post-Operative Pain Control, Combination Product: Surgeon's Standard ACL Postoperative RegimenPatients in the control group will receive standard post-operative pain control. All patients will receive the surgeon's standard ACL postoperative multimodal pain regimen. |
Who may qualify
- Ages
- 14 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- aged 14-65
- undergoing ACL Reconstruction.
Key exclusion criteria (1 listed)
- contraindications to corticosteroids
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methyl Prednisolone (MP)Also: CorticosteroidParticipants will receive 4mg oral tablet of methylprednisolone taper for 6 days after surgery. | Drug | Treatment Group |
| Standard Post-Operative Pain ControlAll patients will receive the surgeon's standard ACL postoperative multimodal pain regimen. | Drug | Control Group |
| Surgeon's Standard ACL Postoperative RegimenAll patients will receive the surgeon's standard ACL postoperative multimodal pain regimen. | Combination product | Control Group, Treatment Group |
Primary outcome
Average Narcotic Consumption Post Surgery
Time frame: Daily up to 6 days and 1 week post op
Paricipants will be assessed on the average amount of pain medication taken on a daily basis.
Percentage of overall Pain Post Operatively
Time frame: Daily for 7 days post op
Participants will be evaluated using the Visual Analogue Scale (VAS) for pain is a self-reported tool, typically a 10-cm horizontal line, anchored by "no pain" (0 cm) and "worst pain" (10 cm). Patients mark their pain level, offering a simple, sensitive, and highly subjective assessment for acute, chronic, or disease-specific pain.
1 secondary outcome
Change in Range of Motion
Time frame: baseline, 2 weeks, 6 weeks and 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Background: PubMed 38316236Wagner ER, Hussain ZB, Karzon AL, Cooke HL, Toston RJ, Hurt JT, Dawes AM, Gottschalk MB. Methylprednisolone taper is an effective addition to multimodal pain regimens after total shoulder arthroplasty: results of a randomized controlled trial: 2022 Neer Award winner. J Shoulder Elbow Surg. 2024 May;33(5):985-993. doi: 10.1016/j.jse.2023.12.016. Epub 2024 Feb 4.
- Individual participant dataSharing planned: No
Related trials for ACL Reconstruction
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Nerve Block of the Vastus Medialis and Anterior Obturator Branch in Anterior Cruciate Ligament Reconstruction With DIDT Graft
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Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
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Graded Exposure and Mindfulness Meditation for Patients Post-ACL Reconstruction
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amit Momaya, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methyl Prednisolone (MP) and Surgeon's Standard ACL Postoperative Regimen in people with ACL Reconstruction, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amit Momaya, MD ((205) 930-8339, amomaya@uabmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Narcotic Consumption Post Surgery (time frame: Daily up to 6 days and 1 week post op). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07605923, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.