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

420 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial studies how well low-dose postoperative corticosteroids (FDA approved) affect patient outcomes (patient reported outcomes, pain medication use, length of stay, major complications, and time to first bowel movement) after thoracic and/or lumbar spine fusion surgery.

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 data supports the effectiveness of the drug Prednisone for spinal fusion?

Prednisone, a type of corticosteroid, is known for its ability to reduce inflammation and is commonly used to treat inflammatory conditions like rheumatoid arthritis. However, while it can help with inflammation, it may also lead to bone loss, which is a concern for spinal fusion as it relies on bone healing and strength. ^{1 2 3 4 5}

What safety data exists for the use of steroids like prednisone in humans?

Steroids like prednisone are generally safe for use in humans, but they can have side effects such as increased risk of infections, bone loss (osteoporosis), and muscle weakness, especially with long-term use. Some studies suggest that low doses may not significantly increase the risk of osteoporosis, but caution is advised, particularly for those on other medications or with existing health conditions. ^{1 2 6 7 8}

How does the drug used in the Steroids for Spinal Fusion trial differ from other treatments?

The drug deflazacort, used in the trial, is a steroid similar to prednisone but with fewer side effects, particularly on calcium and cortisol levels. This makes it potentially safer for long-term use compared to other steroids like prednisone, which can cause rapid bone loss and other metabolic changes. ^{4 7 9 10 11}

Research Team

Jung U Yoo, MD

Principal Investigator

Department of Orthopaedics and Rehabilitation

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

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

Update on Management of the Oral and Maxillofacial Surgery Patient on Corticosteroids. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Spinal and paraspinal inflammatory reactions after epidural steroid injection in a patient taking disease-modifying antirheumatic drugs. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Effects of low dose corticosteroids on bone mass in rheumatoid arthritis: a longitudinal study. [2022]

4. Argentina pubmed.ncbi.nlm.nih.gov

[Vertebral osteoporosis induced by corticoids and cyclosporine ina a patient with Still disease]. [2018]

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

Effects of low-dose prednisone on bone metabolism. [2015]

6. England pubmed.ncbi.nlm.nih.gov

The untoward effects of steroid treatment on the musculoskeletal system and what to do about them. [2019]

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

A double-blind study of deflazacort and prednisone in patients with chronic inflammatory disorders. [2019]

8. Poland pubmed.ncbi.nlm.nih.gov

[Glucocorticosteroid induced osteoporosis in patients with rheumatoid arthritis]. [2022]

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

An update on glucocorticoid-induced osteoporosis. [2022]

10. Australia pubmed.ncbi.nlm.nih.gov

Deflazacort treatment in progressive diaphyseal dysplasia (Camurati-Engelmann disease). [2017]

11. England pubmed.ncbi.nlm.nih.gov

Are changes in bone mineral density different between groups of early rheumatoid arthritis patients treated according to a tight control strategy with or without prednisone if osteoporosis prophylaxis is applied? [2021]