Methylprednisolone Taper for Post-Orthopedic Surgery Recovery

Enrolling by invitation at 3 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Emory University

Must not be taking: Glucocorticoids, Chronic opioids

Disqualifiers: Severe heart disease, Renal failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 6 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a 6-day course of methylprednisolone (a corticosteroid), administered after surgery, can reduce pain and nausea and improve movement in patients recovering from common orthopedic surgeries like hip or knee replacements. Participants will be randomly assigned to receive either the standard treatment of dexamethasone during surgery or dexamethasone followed by the methylprednisolone course. Ideal candidates are those undergoing surgeries on the upper extremity, hip, or knee for arthritis or fractures, and who are treated by Emory Hand Surgeons. As a Phase 4 trial, this research aims to understand how the already FDA-approved and effective treatment benefits more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on daily glucocorticoids or chronic opioids, you cannot participate in the trial.

What is the safety track record for these treatments?

Past studies have shown that a short course of oral methylprednisolone (a type of steroid) after surgery is safe. Research indicates that methylprednisolone can reduce pain and the need for pain medication post-surgery without causing major side effects, making the treatment generally well-tolerated.

Additionally, methylprednisolone is already approved for other medical uses, which supports its safety profile. There is no strong evidence of serious side effects when used briefly after surgery. Overall, the treatment appears safe for most people, but consulting a healthcare provider for personal medical advice is essential. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Most treatments for post-orthopedic surgery recovery typically involve various pain management strategies and anti-inflammatory medications. The combination of dexamethasone and a methylprednisolone taper is unique because it leverages a dual approach of an initial intravenous dose of dexamethasone followed by a short course of oral methylprednisolone. This regimen aims to enhance recovery by reducing inflammation more effectively and potentially speeding up healing. Researchers are excited about this approach because it could offer quicker relief and improved recovery outcomes compared to standard single-dose treatments.

What evidence suggests that this trial's treatments could be effective for post-orthopedic surgery recovery?

In this trial, participants in the Methylprednisolone Treated Group will receive a single intraoperative dose of 10 mg IV dexamethasone, followed by a 6-day oral methylprednisolone taper. Research has shown that a methylprednisolone taper can significantly reduce pain and the need for painkillers after surgery. One study found that patients using this treatment reported less pain and took fewer painkillers in the first week post-surgery. This suggests the taper can manage pain more effectively. Early results also appear promising for reducing pain after shoulder surgeries. While more information is needed, current evidence supports its potential to improve recovery after various bone and joint surgeries. ^{1 3 6 7 8}

Who Is on the Research Team?

Michael Gottschalk, MD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

This trial is for adults aged 18-95 undergoing certain orthopedic surgeries, like joint replacements or tendon repairs. It's not for those with significant other injuries, infections, minors, substance abuse history, severe heart disease, kidney/liver issues, active ulcers, diabetic neuropathy, rheumatoid arthritis affecting pain perception or pregnant women.

Inclusion Criteria

I am having surgery for a tendon issue in my arm or hand.

Patients willing and able to provide written and informed consent

I am having surgery for an upper limb fracture and agree to join the study.

Exclusion Criteria

I am currently pregnant.

I do not have a history of substance abuse, severe allergies, heart, kidney, liver issues, stomach ulcers, diabetic nerve damage, arthritis, or mental health conditions that could affect pain perception.

Subjects who, in the opinion of the investigator, may be non-compliant with study schedules or procedures

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single intraoperative dose of 10 mg IV dexamethasone, with the active group receiving an additional 6-day oral methylprednisolone taper

6 days

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up visits at 2, 6, and 12 weeks postoperatively

12 weeks

3 visits (in-person)

Long-term Follow-up

Participants are monitored for long-term outcomes, including changes in pain, range of motion, and other health measures

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Dexamethasone
• Methylprednisolone

Trial Overview The study tests if a post-operative steroid taper (methylprednisolone) after an IV dose of dexamethasone improves pain control and motion compared to just the IV dose. Patients are randomly assigned to either the standard care group or the group receiving additional oral steroids.

How Is the Trial Designed?

Group I: Control Group Experimental Treatment 1 Intervention

Subjects in this group will receive single intraoperative dose of 10 mg IV dexamethasone; that is 10 mg Intravenous (IV) dexamethasone

Group II: Methylprednisolone Treated Group Active Control 1 Intervention

Subjects in this group will receive single intraoperative course of 10 mg IV dexamethasone \& 6 day oral methylprednisolone taper that is 10 mg Intravenous IV dexamethasone and 6 day oral methylprednisolone taper course

Dexamethasone is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Dexamethasone for:

• Inflammation
• Allergic reactions
• Respiratory diseases
• Skin conditions
• Eye diseases
• Immune system disorders

Approved in United States as Dexamethasone for:

• Inflammatory conditions
• Allergic states
• Respiratory diseases
• Blood disorders
• Neoplastic diseases
• Nervous system disorders

Approved in Canada as Dexamethasone for:

• Inflammation
• Allergic reactions
• Respiratory diseases
• Skin conditions
• Eye diseases

Approved in Japan as Dexamethasone for:

• Inflammatory conditions
• Allergic states
• Respiratory diseases
• Blood disorders

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

Published Research Related to This Trial

A survey of sports medicine physicians revealed that 47% prescribe methylprednisolone taper (Medrol Dosepak) for sports injuries, particularly in patients aged 40 and younger, with postinjury disease being the most common reason for its use.

Concerns about complications, especially the risk of osteonecrosis (reported in 8.5% of prescribers), and a lack of proven efficacy were significant reasons for the 52% of physicians who chose not to prescribe Medrol Dosepak.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survey of orthopaedic and sports medicine physicians regarding use of medrol dosepak for sports injuries. Langer, P., Fadale, P., Hulstyn, M., et al.[2018]

A short course of postoperative dexamethasone after posterior spinal fusion for adolescent idiopathic scoliosis significantly reduced opioid usage by 39.6% without increasing the risk of wound complications, as shown in a study of 113 patients from 2015 to 2018.

Patients receiving steroids were also more likely to walk during their initial physical therapy evaluation, indicating improved recovery outcomes compared to those who did not receive steroids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative Dexamethasone Following Posterior Spinal Fusion for Adolescent Idiopathic Scoliosis. Fletcher, ND., Ruska, T., Austin, TM., et al.[2021]

A systematic review of 8 studies involving 1335 patients found no incidence of surgical site infections (SSI) associated with a single low dose of dexamethasone during hip and knee arthroplasty, suggesting it is safe in this context.

Low-dose dexamethasone effectively prevents post-operative nausea and vomiting (PONV) and improves post-operative pain and recovery quality, although a larger study of 27,205 patients would be needed to definitively assess its safety regarding wound healing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-dose dexamethasone during arthroplasty: What do we know about the risks? Wegener, JT., Kraal, T., Stevens, MF., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11930429/

Administration of a Methylprednisolone Taper and ... Recent preliminary data have suggested that a short course of oral corticosteroid may improve early postoperative pain after various orthopedic operations, but ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03661645

Post-operative Methylprednisolone Taper Course for ... The purpose of this study is to study the efficacy of a post-operative course of glucocorticoids (GCs like Methylprednisolone) on pain, nausea and range of ...

3. jshoulderelbow.org jshoulderelbow.org/article/S1058-2746(24)00083-1/fulltext

Methylprednisolone taper is an effective addition to ... The taper course significantly reduced opioid consumption and postoperative pain scores in the first week after surgery. Based on these findings ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1058274624000831

Shoulder Methylprednisolone taper is an effective addition ... A methylprednisolone taper course shows promise in reducing acute pain and opioid consumption as part of a multimodal regimen following TSA.

5. arthroplastytoday.org arthroplastytoday.org/article/S2352-3441(24)00288-7/pdf

Administration of a Methylprednisolone Taper and ... Limited data exist on the safety of short-term oral corticosteroids following total joint replacement. The present study aims to evaluate ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S1743919118315450

The efficacy and safety of methylprednisolone for pain ... Methylprednisolone could significantly decrease postoperative pain score, narcotic consumption and opioid-related adverse effects after TKA.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11645678/

Does Intra-Operative Methylprednisolone Improve ... Specifically, we hypothesize that intraoperative MP will lead to significant improvements in functional and MRI changes recovery as compared to ...

8. josr-online.biomedcentral.com josr-online.biomedcentral.com/counter/pdf/10.1186/s13018-023-04249-8.pdf?utm_source=consensus

Clinical utilization of methylprednisolone in conjunction ... Effect of high-dose preoperative methylprednisolone on recovery after total hip arthroplasty: a randomized, double-blind, placebo-controlled ...