Methylprednisolone Taper for Post-Orthopedic Surgery Recovery

Recruiting 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

500 Participants Needed

Trial Summary

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 data supports the effectiveness of the drug Methylprednisolone Taper for post-orthopedic surgery recovery?

Research shows that using methylprednisolone can reduce pain and the need for opioids (pain-relieving drugs) after surgery, such as in hand surgeries and total hip arthroplasty. Additionally, dexamethasone, a similar drug, has been found to help with pain and recovery after joint surgeries. ^{1 2 3 4 5}

Is methylprednisolone safe for use in humans after surgery?

Methylprednisolone, a type of corticosteroid, is generally considered safe for short-term use in humans after surgery, but it may have side effects like hyperglycemia (high blood sugar) and potential impacts on wound healing. Studies have shown that low doses of similar corticosteroids like dexamethasone do not significantly increase the risk of surgical site infections, but high doses may affect wound healing. ^{2 4 6 7 8}

How is the drug Dexamethasone unique for post-orthopedic surgery recovery?

Dexamethasone is unique for post-orthopedic surgery recovery because it is used to reduce opioid usage and improve pain control without increasing wound-healing problems, which is a concern with other steroids. ^{2 3 5 6 7}

What is the purpose of this trial?

The clinical trial is a prospective randomized control trial of a group of patients undergoing surgical management of common orthopedic pathologies including fractures of the upper extremity and shoulder arthroplasty; arthritis surgeries (ex. carpometacarpal arthroplasty), release of compressive neuropathies (ex. carpal tunnel surgery), tendon procedures (ex. tendon repair), patients undergoing total hip arthroplasty for osteoarthritis of the hip or total knee arthroplasty for osteoarthritis of the knee. Patients will be assigned randomly to one of two treatment arms: (1) single intraoperative dose of 10 mg intravenous dexamethasone (control group, IV dexamethasone is standard of care) or (2) single intraoperative dose of 10 mg intravenous dexamethasone followed with a 6-day oral methylprednisolone taper course (Active Group). 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 motion after surgical management of common orthopedic upper extremity pathologies, including fractures of the upper extremity and shoulder arthroplasty and patients undergoing total hip arthroplasty for osteoarthritis of the hip or total knee arthroplasty for osteoarthritis of the knee.

Research Team

Michael Gottschalk, MD

Principal Investigator

Emory University

Eligibility Criteria

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.

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

Patients willing and able to provide written and informed consent

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

The AAHKS Best Podium Presentation Research Award: A Second Dose of Dexamethasone Reduces Postoperative Opioid Consumption and Pain in Total Joint Arthroplasty. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

A Prospective Randomized Controlled Trial of Methylprednisolone for Postoperative Pain Management of Surgically Treated Distal Radius Fractures. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Postoperative Dexamethasone Following Posterior Spinal Fusion for Adolescent Idiopathic Scoliosis. [2021]

4. Germany pubmed.ncbi.nlm.nih.gov

The efficacy and safety of two low-dose peri-operative dexamethasone on pain and recovery following total hip arthroplasty: a randomized controlled trial. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Effect of high-dose preoperative methylprednisolone on recovery after total hip arthroplasty: a randomized, double-blind, placebo-controlled trial. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Survey of orthopaedic and sports medicine physicians regarding use of medrol dosepak for sports injuries. [2018]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Risks and benefits of preoperative high dose methylprednisolone in surgical patients: a systematic review. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Low-dose dexamethasone during arthroplasty: What do we know about the risks? [2020]