StenosisPhase 3NCT03327272
Impact of Local Steroid Application in Extreme Lateral Lumbar Interbody Fusion
A Phase 3 study testing Methylprednisolone and Saline in people with Stenosis and Herniated Nucleus Pulposus, run by Rush University Medical Center at 1 site in United States.
Trial summary
Neural injury is a well-known complication following extreme lateral lumbar interbody fusion (XLIF). It has been found that up to 9.4% of patients will have either temporary or persistent neurologic deficit. This occurs with traversal of the psoas muscle or direct injury to lumbosacral plexus or sympathetic ganglion. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Stenosis, Herniated Nucleus Pulposus, Degenerative Disc Disease
- What is being tested?
- Methylprednisolone and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 22 May 2018to 24 Jul 2020
- Phase
- Phase 3
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients undergoing a 1- to 2-level XLIF
- Diagnosis: myelopathy, radiculopathy, myeloradiculopathy, stenosis, herniated nucleus pulposus, degenerative disc disease, spondylosis, osteophytic complexes, and foraminal stenosis
- Patients able to provide informed consent
Who cannot join
- Allergies or other contraindications to medicines in the protocol including:
- Existing history of gastrointestinal bleeding
- Lumbar spine trauma
- Unable to speak, read, or understand English
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
Neural injury is a well-known complication following extreme lateral lumbar interbody fusion (XLIF). It has been found that up to 9.4% of patients will have either temporary or persistent neurologic deficit. This occurs with traversal of the psoas muscle or direct injury to lumbosacral plexus or sympathetic ganglion. While often temporary, it can cause hip flexor weakness, thigh numbness, or pain.
Several studies have demonstrated reduced patient reported pain scores following steroid administration, particularly in the early postoperative period. However, few studies have investigated the efficacy of intraoperative local injection of corticosteroid in reducing the incidence and duration of postoperative pain or neurologic injury for XLIF patients.
Read the detailed description
The purpose of this study is to determine if the incidence and duration of postoperative pain is reduced in the subjects receiving a local injection of methylprednisolone when compared to placebo following XLIF.
The investigators hypothesize that subjects undergoing XLIF who receive local methylprednisolone will have:
- Reduced incidence and duration of postoperative pain and neurologic injury
- Shorter hospital stay
- Better short- and long-term outcomes
The study also aims to answer the following questions:
- Do subjects who receive local corticosteroids have a reduced incidence and duration of postoperative pain and neurologic deficit compared to those who receive placebo?
- Do subjects who receive local corticosteroids have a reduced hospital stay compared to those who received placebo?
- Is local corticosteroid therapy associated with improved short and long-term outcomes?
- Conditions
- Stenosis, Herniated Nucleus Pulposus, Degenerative Disc Disease, Spondylosis, Myelopathy, Radiculopathy
- Being tested
- Methylprednisolone, Saline
- Medical subject headings
- Constriction, Pathologic, Intervertebral Disc Degeneration, Spondylosis, Spinal Cord Diseases, Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called Depomedrol
Injection of 80mg Depomedrol injectable suspension at surgical site prior to incision closure
SalineDrug
Administration of saline at surgical site prior to incision closure
| Study group | Role | What they receive |
|---|---|---|
| Local injection of methylprednisolone | Active comparator | Drug: methylprednisolone Injection of 80mg methylprednisolone injectable suspension at surgical site prior to incision closure Receives: Drug: Methylprednisolone |
| Local injection of saline | Placebo comparator | Administration of saline at surgical site prior to incision closure. Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain
Change in Visual Analogue Scale (VAS) Back and Leg pain score from preoperative value will be assessed. VAS back and leg pain scores assess pain in each region on a scale from 0-10 with 0 being no pain and 10 being worst pain imaginable.
Measured: 2 year postoperative
Secondary outcomes (6)
Physical Functioning
Patient-Reported Outcomes Measurement Information System (PROMIS) physical function score as compared to preoperative value. This score assesses physical function and is scaled from 0-100 with 100 indicating greater functioning and 0 indicating worse functioning.
Measured: 2 year postoperative
Disability
Oswestry Disability Index (ODI) score as compared to preoperative score. ODI assesses disability out of a total of 50 points and is scaled to a percentage of total possible points with 0 indicating no disability and 100 indicating severe disability.
Measured: 2 year postoperative
General health status
Short Form (SF)-12 Survey scores as compared to preoperative values. SF-12 assesses general physical and mental health on a scale of 0 to 100 with higher scores indicating superior health status
Measured: 2 year postoperative
Narcotic Consumption
The total amount of narcotic use for each subject will be recorded. Dosages of narcotics will be converted to morphine equivalents
Measured: 2 year postoperative
Length of Stay
The number of hours of hospitalization from entering the recovery room (time zero) until patient meets discharge criteria
Measured: 1 week postoperative
Post-operative adverse events
Post-operative nausea and vomiting, Gastro-esophageal reflux, Ileus, Venous thromboembolic events, Respiratory depression/airway compromise, Renal insufficiency, Wound Complications, Admission to the ICU
Measured: 1 week postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2017
- Study start22 May 2018
- Primary completion24 Jul 2020
- Study completion24 Jul 2020
Why it stopped: Did not enroll, PI decided not to proceed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StenosisStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kern Singh, Rush University Medical Center
- Investigators
- Kern Singh, MD, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03327272
- Sponsor's protocol ID
- 17102301
- Status last verified
- Nov 2020
- First submitted
- 26 Oct 2017
- Last updated
- 20 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- 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 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Local Steroid Application in Extreme Lateral Lumbar Interbody Fusion
- ClinicalTrials.gov ID
- NCT03327272
- Acronym / sponsor ID
- 17102301
- Conditions
- Stenosis, Herniated Nucleus Pulposus, Degenerative Disc Disease, Spondylosis, Myelopathy, Radiculopathy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Did not enroll, PI decided not to proceed.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 22 May 2018 (actual)
- Primary completion
- 24 Jul 2020 (actual)
- Study completion
- 24 Jul 2020 (actual)
- First posted
- 31 Oct 2017 (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.
Neural injury is a well-known complication following extreme lateral lumbar interbody fusion (XLIF). It has been found that up to 9.4% of patients will have either temporary or persistent neurologic deficit. This occurs with traversal of the psoas muscle or direct injury to lumbosacral plexus or sympathetic ganglion. While often temporary, it can cause hip flexor weakness, thigh numbness, or pain.
Several studies have demonstrated reduced patient reported pain scores following steroid administration, particularly in the early postoperative period. However, few studies have investigated the efficacy of intraoperative local injection of corticosteroid in reducing the incidence and duration of postoperative pain or neurologic injury for XLIF patients.
Detailed description
The purpose of this study is to determine if the incidence and duration of postoperative pain is reduced in the subjects receiving a local injection of methylprednisolone when compared to placebo following XLIF.
The investigators hypothesize that subjects undergoing XLIF who receive local methylprednisolone will have:
- Reduced incidence and duration of postoperative pain and neurologic injury
- Shorter hospital stay
- Better short- and long-term outcomes
The study also aims to answer the following questions:
- Do subjects who receive local corticosteroids have a reduced incidence and duration of postoperative pain and neurologic deficit compared to those who receive placebo?
- Do subjects who receive local corticosteroids have a reduced hospital stay compared to those who received placebo?
- Is local corticosteroid therapy associated with improved short and long-term outcomes?
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Local injection of methylprednisolone | Active comparator | Drug: MethylprednisoloneDrug: methylprednisolone Injection of 80mg methylprednisolone injectable suspension at surgical site prior to incision closure |
| Local injection of saline | Placebo comparator | Drug: SalineAdministration of saline at surgical site prior to incision closure. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing a 1- to 2-level XLIF
- Diagnosis: myelopathy, radiculopathy, myeloradiculopathy, stenosis, herniated nucleus pulposus, degenerative disc disease, spondylosis, osteophytic complexes, and foraminal stenosis
- Patients able to provide informed consent
Key exclusion criteria (4 listed)
- Allergies or other contraindications to medicines in the protocol including:
- Existing history of gastrointestinal bleeding
- Lumbar spine trauma
- Unable to speak, read, or understand English
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 |
|---|---|---|
| MethylprednisoloneAlso: DepomedrolInjection of 80mg Depomedrol injectable suspension at surgical site prior to incision closure | Drug | Local injection of methylprednisolone |
| SalineAdministration of saline at surgical site prior to incision closure | Drug | Local injection of saline |
Primary outcome
Postoperative Pain
Time frame: 2 year postoperative
Change in Visual Analogue Scale (VAS) Back and Leg pain score from preoperative value will be assessed. VAS back and leg pain scores assess pain in each region on a scale from 0-10 with 0 being no pain and 10 being worst pain imaginable.
6 secondary outcomes
Physical Functioning
Time frame: 2 year postoperative
Disability
Time frame: 2 year postoperative
General health status
Time frame: 2 year postoperative
Narcotic Consumption
Time frame: 2 year postoperative
Length of Stay
Time frame: 1 week postoperative
Post-operative adverse events
Time frame: 1 week postoperative
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2020.
- 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.
Kern Singh, MD principal investigator
Rush University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Methylprednisolone and Saline in people with Stenosis and Herniated Nucleus Pulposus, run by Rush University Medical Center 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 3 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: withdrawn, as of the sponsor's last update on 20 Nov 2020. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain (time frame: 2 year postoperative). 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 20 Nov 2020.