Impact of Local Steroid Application in Extreme Lateral Lumbar Interbody Fusion
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|ClinicalTrials.gov Identifier: NCT03327272|
Recruitment Status : Recruiting
First Posted : October 31, 2017
Last Update Posted : August 29, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Stenosis Herniated Nucleus Pulposus Degenerative Disc Disease Spondylosis Myelopathy Radiculopathy Myeloradiculopathy||Drug: Methylprednisolone Drug: Saline||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Impact of Local Steroid Application in Extreme Lateral Lumbar Interbody Fusion|
|Actual Study Start Date :||May 22, 2018|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
Active Comparator: Local injection of methylprednisolone
Drug: methylprednisolone Injection of 80mg methylprednisolone injectable suspension at surgical site prior to incision closure
Injection of 80mg Depomedrol injectable suspension at surgical site prior to incision closure
Other Name: Depomedrol
Placebo Comparator: Local injection of saline
Administration of saline at surgical site prior to incision closure.
Administration of saline at surgical site prior to incision closure
- 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.
- Physical Functioning [ Time Frame: 2 year postoperative ]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.
- Disability [ Time Frame: 2 year postoperative ]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.
- General health status [ Time Frame: 2 year postoperative ]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
- Narcotic Consumption [ Time Frame: 2 year postoperative ]The total amount of narcotic use for each subject will be recorded. Dosages of narcotics will be converted to morphine equivalents
- Length of Stay [ Time Frame: 1 week postoperative ]The number of hours of hospitalization from entering the recovery room (time zero) until patient meets discharge criteria
- Post-operative adverse events [ Time Frame: 1 week postoperative ]Post-operative nausea and vomiting, Gastro-esophageal reflux, Ileus, Venous thromboembolic events, Respiratory depression/airway compromise, Renal insufficiency, Wound Complications, Admission to the ICU
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03327272
|Contact: Susan Dvojack, MS||3129426689||Susan_Dvojack@rush.edu|
|United States, Illinois|
|Rush University Medical Center||Recruiting|
|Chicago, Illinois, United States, 60612|
|Contact: Susan Dvojack 312-942-6689 Susan_Dvojack@rush.edu|
|Principal Investigator:||Kern Singh, MD||Rush University Medical Center|