Spine FusionPhase 4NCT04568837
Steroids After Spine Fusion Surgery
A Phase 4 study testing Prednisone 20 Mg in people with Spine Fusion, run by Oregon Health and Science University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spine Fusion
- What is being tested?
- Prednisone 20 Mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2025to 6 Oct 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients over the age of 50 undergoing thoracic and/or lumbar fusion with a Spine Center surgeon will be included
Who cannot join
- Patient is already taking chronic steroids
- Patient is pregnant
- Patient is decisionally impaired
- Patient is a prisoner
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health and Science University
Portland, Oregon, 97239
Spencer J Smith, BS, 503-828-7136, smithsp@ohsu.edu
About this study
Official title: Postoperative Steroids and Recovery After Spine Fusion
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.
Read the detailed description
PRIMARY OBJECTIVES This study aims to compare patient outcomes (patient reported outcomes, pain medication use, length of stay, major complications, and time to first bowel movement) between subjects that receive either 20 mg of PO prednisone or 1 mL of 4 mg/mL of IV dexamethasone sodium phosphate and a control group.
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
- Spine Fusion
- Being tested
- Prednisone 20 Mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prednisone 20 MgDrug
Also called Dexamethasone Sodium Phosphate 1 mL 4 mg/mL
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
| Study group | Role | What they receive |
|---|---|---|
| Corticosteroid | Experimental | Participants in this group will receive a daily dose of corticosteroids on postoperative day one and two after spine fusion surgery Receives: Drug: Prednisone 20 Mg |
| Control | No intervention | Participants in this group will receive no steroids on postoperative day one and two after spine fusion surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine equivalent pain medication use over the length of hospitalization
This will be measured by converting the dosage of the pain medication administered to its equivalent dosage of morphine.
Measured: From postoperative admission to discharge, up to 4 weeks
Length of hospital stay after surgery
This will be measured by taking the total minutes the patient stays in the hospital after surgery from time of admission to time of discharge.
Measured: From postoperative admission to discharge, up to 4 weeks
Time to first bowel movement in hospital after surgery
This will be measured in the total number of minutes from admission after surgery that it takes for the patient to have their first bowel movement recorded.
Measured: From postoperative admission to discharge, up to 4 weeks
Number of major complications reported during hospital stay after surgery
This will be measured in the total number of major complications (any) that occur during the hospital stay after surgery. These include, infection, neurological deficit, myocardial infarction, stroke, pneumonia, pulmonary embolism, and bleeding.
Measured: From postoperative admission to discharge, up to 4 weeks
Morphine equivalent pain medication use over the first 48 hours of hospitalization
This will be measured by converting the dosage of the pain medication administered to its equivalent dosage of morphine.
Measured: From postoperative admission to 48 hours after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2020
- Study start1 Mar 2025 (estimated)
- Primary completion6 Oct 2026 (estimated)
- Study completion6 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spine FusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized into one of two groups: treatment group vs control (no treatment) group
- Masking
- None (open label)
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jung Yoo, Oregon Health and Science University
- Investigators
- Jung U Yoo, MD, Principal investigator, Department of Orthopaedics and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04568837
- Sponsor's protocol ID
- STUDY00021169
- Status last verified
- Apr 2024
- First submitted
- 21 Sep 2020
- Last updated
- 22 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Steroids and Recovery After Spine Fusion
- ClinicalTrials.gov ID
- NCT04568837
- Acronym / sponsor ID
- STUDY00021169
- Conditions
- Spine Fusion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 6 Oct 2026 (estimated)
- Study completion
- 6 Oct 2026 (estimated)
- First posted
- 29 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES This study aims to compare patient outcomes (patient reported outcomes, pain medication use, length of stay, major complications, and time to first bowel movement) between subjects that receive either 20 mg of PO prednisone or 1 mL of 4 mg/mL of IV dexamethasone sodium phosphate and a control group.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomized into one of two groups: treatment group vs control (no treatment) group
| Arm | Type | Receives |
|---|---|---|
| Corticosteroid | Experimental | Drug: Prednisone 20 MgParticipants in this group will receive a daily dose of corticosteroids on postoperative day one and two after spine fusion surgery |
| Control | No intervention | –Participants in this group will receive no steroids on postoperative day one and two after spine fusion surgery. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients over the age of 50 undergoing thoracic and/or lumbar fusion with a Spine Center surgeon will be included
Key exclusion criteria (4 listed)
- Patient is already taking chronic steroids
- Patient is pregnant
- Patient is decisionally impaired
- Patient is a prisoner
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prednisone 20 MgAlso: Dexamethasone Sodium Phosphate 1 mL 4 mg/mL20 mg of Prednisone or 1 mL of 4 mg/mL Dexamethasone Sodium Phosphate will be administered each day for participants in the intervention group | Drug | Corticosteroid |
Primary outcome
Morphine equivalent pain medication use over the length of hospitalization
Time frame: From postoperative admission to discharge, up to 4 weeks
This will be measured by converting the dosage of the pain medication administered to its equivalent dosage of morphine.
Length of hospital stay after surgery
Time frame: From postoperative admission to discharge, up to 4 weeks
This will be measured by taking the total minutes the patient stays in the hospital after surgery from time of admission to time of discharge.
Time to first bowel movement in hospital after surgery
Time frame: From postoperative admission to discharge, up to 4 weeks
This will be measured in the total number of minutes from admission after surgery that it takes for the patient to have their first bowel movement recorded.
Number of major complications reported during hospital stay after surgery
Time frame: From postoperative admission to discharge, up to 4 weeks
This will be measured in the total number of major complications (any) that occur during the hospital stay after surgery. These include, infection, neurological deficit, myocardial infarction, stroke, pneumonia, pulmonary embolism, and bleeding.
Morphine equivalent pain medication use over the first 48 hours of hospitalization
Time frame: From postoperative admission to 48 hours after
This will be measured by converting the dosage of the pain medication administered to its equivalent dosage of morphine.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jung U Yoo, MD principal investigator
Department of Orthopaedics and Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prednisone 20 Mg in people with Spine Fusion, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Spencer J Smith, BS (503-828-7136, smithsp@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morphine equivalent pain medication use over the length of hospitalization (time frame: From postoperative admission to discharge, up to 4 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2024.