A Phase 3 interventional study of Methylprednisolone and Saline in Stenosis, Herniated Nucleus Pulposus and Degenerative Disc Disease, sponsored by Rush University Medical Center. Withdrawn at 1 site in United States. Per ClinicalTrials.gov, last updated 2020-11-20.
Sponsored by Rush University Medical Center · Phase 3, Interventional, and Prevention
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Among 116 studies in Constriction, Pathologic with a site in United States — 14 open to participants now, 19 under way, 2 of them phase 3. Constriction, Pathologic · United States.
Among the 116 studies in Constriction, Pathologic with a site in United States, this one is the 76th largest by enrollment of the 82 interventional ones that give a count, is one of 4 that started in 2018, is one of 5 in phase 3, and was the 78th registered.
457 studies on the registry are indexed under Constriction, Pathologic; 110 are open to participants now.
Browse Constriction, Pathologic studies →14 of the 116 studies in Constriction, Pathologic with a site in United States are open now. Recruiting first, the newest first:
Johns Hopkins University · Sites in United States
Ages 18–80
Medical College of Wisconsin · Sites in United States
Ages 18+
Urotronic Inc. · Sites in United States
Ages 18+
Children's Hospital Los Angeles · Sites in United States
Ages 12–21
NYU Langone Health · Sites in United States
Ages 48+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 67 Constriction, Pathologic studies recruiting now, 34 (51%) set no upper age limit and 14 (21%) stop at 75 or younger; 8 take children under 18; 1 takes healthy volunteers.
This study: all sexes · healthy volunteers too.
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116 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 6 · Phase 2 12 · Phase 3 6 · Phase 4 9
First in 2000; this study’s year is marked. 4 started in 2018.
By drug class, each counting the studies that test any of its medicines:
Median enrollment 40 across the 82 interventional studies, 62 across the 32 observational. Of the 81 that completed or were terminated, 40 (49%) have results posted.
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44 of 116 have an industry lead sponsor. The 10 most frequent:
Rush University Medical Center is the lead sponsor of 397 studies on the registry; 61 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 26 (81%) have results posted.
Rush University Medical Center has 1 study filed under Constriction, Pathologic — fewer than ten, so there is no comparison to draw.
8 of the studies in Constriction, Pathologic with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07456137University of Kansas Medical CenterProspective Evaluation of Upright Versus Supine CT Myelography of the Lumbar Spine | 2026-12 |
| NCT05691062Twin Cities Spine CenterTitanium vs. PEEK Fusion Devices in 1 Level TLIF | 2027-01-11 |
| NCT06410313Medinol Ltd.First In Human Study to Assess Safety and Efficacy of the ChampioNIR™ Drug Eluting Peripheral Stent in the Treatment of Patients With Superficial Femoral Artery Disease and/or Proximal Popliteal Artery Disease | 2027-01-30 |
| NCT07020520Urotronic Inc.EvaluatioN of Optilume Drug-Coated Balloon for the Endoscopic Treatment of UREteric Strictures | 2027-02-28 |
| NCT05779436Mayo ClinicReal-Time Cholangioscopy Artificial Intelligence Evaluation of Biliary Strictures | 2027-03 |
Add all 8 to your calendar (.ics) → With an account.
Among the 116 studies in Constriction, Pathologic with a site in United States, from their registry updates:
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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.
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:
The study also aims to answer the following questions:
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: methylprednisolone Injection of 80mg methylprednisolone injectable suspension at surgical site prior to incision closure
Drug: Methylprednisolone
Administration of saline at surgical site prior to incision closure.
Drug: Saline
Injection of 80mg Depomedrol injectable suspension at surgical site prior to incision closure
Also known as: Depomedrol
Administration of saline at surgical site prior to incision closure
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.
Time frame: 2 year postoperative
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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 2 year postoperative
Length of Stay
The number of hours of hospitalization from entering the recovery room (time zero) until patient meets discharge criteria
Time frame: 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
Time frame: 1 week postoperative
Plan to share: No
No publications or documents are linked to this record.
Ran from May 2018 to primary completion in Jul 2020, 26 months.
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This study is withdrawn, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Methylprednisolone
Rush University Medical Center →