Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
420 participants
INTERVENTIONAL
2025-03-01
2026-10-06
Brief Summary
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Detailed Description
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OUTLINE Participants are patients who elect to participate in the study prior to scheduled thoracic and/or lumbar spine fusion surgery at Oregon Health and Science University. Participants undergo their scheduled spine fusion surgery. After surgery, participants are randomized into either the study drug group or the control (non-treatment) group. If randomized into the study drug group, participants will orally take a daily dose of 20 mg of prednisone (1 mL of 4 mg/mL dexamethasone sodium phosphate if unable to tolerate oral administration) on postoperative days one and two.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Corticosteroid
Participants in this group will receive a daily dose of corticosteroids on postoperative day one and two after spine fusion surgery
Prednisone 20 Mg
20 mg of Prednisone or 1 mL of 4 mg/mL Dexamethasone Sodium Phosphate will be administered each day for participants in the intervention group
Control
Participants in this group will receive no steroids on postoperative day one and two after spine fusion surgery.
No interventions assigned to this group
Interventions
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Prednisone 20 Mg
20 mg of Prednisone or 1 mL of 4 mg/mL Dexamethasone Sodium Phosphate will be administered each day for participants in the intervention group
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patient is pregnant
* Patient is decisionally impaired
* Patient is a prisoner
50 Years
ALL
Yes
Sponsors
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Oregon Health and Science University
OTHER
Responsible Party
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Jung Yoo
Principal Investigator
Principal Investigators
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Jung U Yoo, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Orthopaedics and Rehabilitation
Locations
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Oregon Health and Science University
Portland, Oregon, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STUDY00021169
Identifier Type: -
Identifier Source: org_study_id
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