Steroids for Spinal Fusion

Overseen By Spencer J Smith, BS

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Oregon Health and Science University

Must not be taking: Chronic steroids

Disqualifiers: Pregnancy, Decisionally impaired, Prisoner

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 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of low-dose prednisone, a type of corticosteroid, for individuals who have recently undergone thoracic or lumbar spine fusion surgery. The researchers aim to determine if this medication can improve recovery aspects such as pain, hospital stay length, and complications. Participants will be divided into two groups: one will receive the corticosteroid after surgery, while the other will not. The trial seeks individuals over 50 who are undergoing spine fusion surgery and are not currently using steroids. As a Phase 4 trial, this research focuses on understanding how an already FDA-approved and effective treatment can benefit 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, but you cannot participate if you are already taking chronic steroids.

What is the safety track record for Prednisone?

Research has shown that prednisone, a corticosteroid, is FDA-approved and generally safe for use. In past studies, about 93.6% of patients experienced good outcomes after surgery when given corticosteroids. However, some risks exist. Studies have found that corticosteroids can slightly increase the likelihood of complications, such as infections or the need for additional surgery. Despite these risks, there is no strong link between corticosteroid use and hospital readmission. Overall, while many tolerate prednisone well, awareness of possible complications is important. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard care for spinal fusion, which typically focuses on pain management and physical therapy, the use of corticosteroids like prednisone is unique because it targets inflammation directly. Researchers are excited about this treatment because corticosteroids can potentially reduce inflammation and swelling more quickly than traditional methods. This could lead to a faster recovery time and improved patient outcomes by minimizing pain and complications in the critical days following surgery.

What evidence suggests that low-dose corticosteroids are effective for improving outcomes after spine fusion surgery?

Research has shown that small doses of corticosteroids, such as prednisone, can reduce symptoms and improve quality of life after spine surgery. In this trial, participants in the corticosteroid arm will receive a daily dose of corticosteroids on postoperative days one and two after spine fusion surgery. One study found that corticosteroids lessen pain and discomfort in the days following lower back surgery. Another study discovered that injecting steroids during surgery reduced back pain by lowering swelling. Although some risks of complications exist, there is no increased chance of needing to return to the hospital. Overall, these findings suggest that prednisone can effectively ease recovery after spine surgery. ^{1 2 3 4 6}

Who Is on the Research Team?

Jung U Yoo, MD

Principal Investigator

Department of Orthopaedics and Rehabilitation

Are You a Good Fit for This Trial?

This trial is for individuals over 50 years old who are having thoracic and/or lumbar spine fusion surgery. It's not open to prisoners, those with decision-making impairments, pregnant women, or anyone already on chronic steroids.

Inclusion Criteria

All patients over the age of 50 undergoing thoracic and/or lumbar fusion with a Spine Center surgeon will be included

Exclusion Criteria

Patient is a prisoner

You are not able to make decisions for yourself.

You are pregnant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo scheduled thoracic and/or lumbar spine fusion surgery

1 day

1 visit (in-person)

Postoperative Treatment

Participants receive either corticosteroids or no treatment on postoperative days one and two

2 days

Hospital Stay

Participants are monitored for major complications, pain medication use, and time to first bowel movement

Up to 4 weeks

Follow-up

Participants are monitored for safety and effectiveness after discharge

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Prednisone

Trial Overview The study is examining the effects of a low-dose corticosteroid called Prednisone (20 mg) after spine fusion surgery. It looks at patient recovery outcomes like pain levels, medication use, hospital stay duration, complications, and time to first bowel movement.

How Is the Trial Designed?

Group I: Corticosteroid Experimental Treatment 1 Intervention

Participants in this group will receive a daily dose of corticosteroids on postoperative day one and two after spine fusion surgery

Group II: Control Active Control 1 Intervention

Participants in this group will receive no steroids on postoperative day one and two after spine fusion surgery.

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials

1,024

Recruited

7,420,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10829405/

Effectiveness of Corticosteroid Therapy in Enhancing Early ... Small doses of corticosteroid therapy for postoperative lumbar spinal stenosis reduced symptoms and improved quality of life scores after surgery.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6293428/

The Effects of Chronic Preoperative Steroid Therapy on ... Patients on chronic preoperative steroid therapy are at increased risk of multiple perioperative complications following elective PLF.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1878875017319538

The Effect of Steroids on Complications, Readmission, and ... The use of corticosteroid therapy is associated with a moderately increased risk of overall complications, but no association was found with readmission or ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04568837

NCT04568837 | Steroids After Spine Fusion Surgery This trial studies how well low-dose postoperative corticosteroids (FDA approved) affect patient outcomes (patient reported outcomes, pain medication use, ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2666548424000672

36. Effects of intraoperative epidural steroids for lumbar ... Local epidural injection of steroids significantly reduced low back pain and wound pain by suppressing local inflammation for several days after surgery.

6. researchgate.net researchgate.net/publication/321130327_The_Effect_of_Steroids_on_Complications_Readmission_and_Reoperation_After_Posterior_Lumbar_Fusion

The Effect of Steroids on Complications, Readmission, and ... The data from this study, demonstrating increased odds of reoperation, deep and superficial SSI, and ED visits, aligns with the existing ...