N/A N=158 Study to Evaluate Safety and Effectiveness of Spinal Sealant
Spinal Procedure Requiring Dura Incision
Primary: Watertight Dural Closure — 102; 36 Participants
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
N/A N=98 Study to Evaluate Safety & Effectiveness of Spinal Sealant
Cerebrospinal Fluid Leakage, Subdural
Primary: Percent(%) Success in Obtaining a Watertight Closure Following Assigned Treatment (Spinal Sealant or Control) — 98.0; 79.2 percentage of participants
N/A N=40 Percutaneous Diskectomy SpineJet x Open Microdiskectomy in Treatment of Lumbar Radiculopathy
Radiculopathy · Herniated Disk
Primary: VAS for Lumbar Pain in 3 Months — 2.63; 4.53 units on a scale — p=0.05
N/A N=237 DuraSeal Sealant Post Market Study
Elective Cranial Procedures With Dural Incision
Primary: Percentage of Subjects With Surgical Wound Complications, Central Nervous System Events, and Neurosurgical Complications Related to Unplanned Intervention or Return to…
Phase 4 N=63 Intraoperative Infusion of Precedex to Reduce Length of Stay After Lumbar Spine Fusion
Spinal Fusion Acquired · Spinal Stenosis · Lesions of Lumbosacral Intervertebral Disc
Primary: Time Required After Surgery to Reach Fitness for Discharge From Hospital — 3.2; 3.2 days — p=0.36
N/A N=162 Posterior Fossa Decompression With or Without Duraplasty for Chiari Type I Malformation With Syringomyelia
Arnold-Chiari Malformation, Type 1 · Chiari Malformation Type I · Type I Arnold-Chiari Malformation
Primary: The Number of Participants With Surgical Complications — 8; 10 Participants
N/A N=105 Study of SyntheCelTM Dura Replacement to Other Dura Replacements
Cranial Dura Repair
Primary: Absence of Cerebrospinal Fluid (CSF) Fistula and Pseudomeningocele — 57; 33 participants
N/A N=337 5-Year Global Study on MAST™ Minimally Invasive Fusion Procedures to Treat Degenerative Lumbar Spine (MASTERS-D2)
Intervertebral Disc Degeneration
Primary: Change (Preop-postop) of Disability, Oswestry Disability Index (ODI) at 3 Months as Compared to Baseline in DDD Patients With Spondylolisthesis — 23.19; 26.08 change of…
Phase 4 N=146 Herniectomy Versus Herniectomy With a Spinal Stabilization System for the Treatment of Complex Disc Disease
Sciatica · Back Pain
Primary: To Demonstrate a Statistically Significant Difference in the Relief of Back Pain Between Both Treatment Groups. The Endpoint Will be the Difference Between Baseline and…
N/A N=92 A Prospective, Randomized, Controlled Multi-center Study of ArtiFascia® Dural Repair Patch Compared With Commercially Available Dural Substitutes. To Evaluate the Safety and Effectiveness of ArtiFascia® in Subjects Requiring Dural Repair.
Dural Tear · Cerebrospinal Fluid Leak
Primary: Absence of Cerebrospinal Fluid Fistula (Drainage From Wound or Sinus) and Pseudo-meningocele Within 6 Months Post-operative as Evaluated by MRI Imaging. — 0; 0; 27; 58…
N/A N=116 Perioperative Intravenous Lidocaine or Epidural Anesthesia on Outcomes in Complex Spine Surgery
Spine Surgery
Primary: Mean Pain Scores — 4.4; 5.3 verbal response scores — p=<0.001
Phase 4 N=55 MiDAS II (Mild® Decompression Alternative to Open Surgery): Vertos Mild Patient Evaluation Study
Lumbar Spinal Stenosis
Primary: Changes in Back Pain as Measured by a 10-point Visual Analog Scale (VAS). — 3.59 units on a scale — p=<0.0001
N/A N=20 A Novel Method for Capturing the Visual Evoked Potential During Spine Surgery Under Total Intravenous Anesthesia
Evoked Potentials, Visual
Primary: Number of Participants With Presence of VEPs — 18 Participants
Phase 4 N=60 TissueLink Study During Multi-Level Spine Surgery
Low Back Pain
Primary: Hemoglobin Measurement g/dl — 66.2; 102.4 hemoglobin g/dl
N/A N=63 Intraoperative Ocular Pressure in Lumbar Spine Fusion Patients
Raised Ocular Pressure
Primary: Change in Intraoperative Ocular Pressure in Lumbar Spine Fusion Patients Head Raised 10 Degrees or Kept in Neutral Position — 9.26; 13.79 mm Hg
N/A N=92 Epidural Neuroplasty for the Treatment of Herniated Lumbar Disk
Herniated Lumbar Disc
Primary: Pain Assessed by Visual Analogue Scale — 5.63; 5.92 units on a scale
N/A N=710 INFUSE® Bone Graft/ PEEK Interbody Spacer/ Anterior Cervical Plate Pivotal Clinical Trial
Degenerative Disc Disease
Primary: Rate of Overall Success — 80.9; 59.9 percentage of participants — p=<0.001
Phase 3 N=34 Duragen Versus Duraguard in Chiari Surgery
Chiari Malformation
Primary: Physical Health Quality of Life — 31.4; 35.61 units on a scale
N/A N=138 MiDAS III (Mild® Decompression Alternative to Open Surgery): Vertos Mild Patient Evaluation Study
Lumbar Spinal Stenosis
Primary: Percentage of Participants With a 2-point Improvement in Visual Analogue Scale — 65.71; 46.15 percentage of responders
Phase 4 N=79 C7-T1 Epidural Steroid Injections Versus Targeted Injection for Treatment of Cervical Radicular Pain
Radicular; Neuropathic, Cervical · Neck Pain
Primary: Percentage of Participants With ≥50% Pain Reduction on the Numeric Rating Score (NRS) for Pain — 60; 72 percentage of participants — p=0.23
N/A N=50 Accuracy of Manual Palpation vs Ultrasound for Spinal Anesthesia
Anesthesia, Local · Infant Conditions
Primary: Intended Interspace — 1; 24; 25 Participants
N/A N=575 LDR Spine USA Mobi-C(R) Cervical Disc Prosthesis IDE
Degenerative Disc Disease
Primary: Composite Definition of Study Success — 65.3; 73.7; 37.4; 69.7 percentage of subjects analyzed — p=0.0021
N/A N=46 Vertos Mild - Post Market Patient Outcomes
Lumbar Spinal Stenosis
Primary: Pain as Measured by Visual Analog Scale (VAS). — 2.17 units on a scale — p=<0.0001
N/A N=106 Follow-up of Post-spinal Implantable Neurostimulator PRECISION®
Chronic Refractory Neuropathic Pain · Ischemic Peripheral Pain
Primary: Percentage of Implanted Patients (de Novo Implants) With an Improvement of at Least 50% of the Overall Average Pain Over the Last 8 Days, Evaluated by Numerical Scale at…
N/A N=302 The MiDAS ENCORE Study
Spinal Stenosis, Lumbar Region, With Neurogenic Claudication
Primary: Number of Participants Who Achieved a Clinically Significant Improvement in the Oswestry Disability Index at 12 Months — 83; 35 Participants
N/A N=260 Comparison of Two Spinal Needles Regarding Postdural Puncture Headache
Anesthesia; Adverse Effect, Spinal and Epidural, Headache · Complications; Anesthesia, Spinal and Epidural, in Pregnancy
Primary: Postdural Puncture Headache in Patients Receiving Spinal Anesthesia for Cesarean Section — 14; 10 participants
N/A N=100 Safety and Efficacy of DepoDur in Lumbar Spine Surgery Patients
Lumbar Spine Surgery
Primary: Number of Patients Enrolled and Recieving Injection — 98 participants
Phase 3 N=224 Efficacy and Safety of FS VH S/D 500 S-apr (Tisseel) as an Adjunct to Sutured Dural Repair in Cranial Surgery
Cerebrospinal Fluid Leak
Primary: Number of Participants With No CSF Leak During and After Surgery — 76; 87 Participants
Phase 4 N=65 Surgery Prevention by Transforaminal Injection of Epidural Steroids for Cervical Radicular Pain
Pain, Radiating
Primary: Avoidance of Neck Surgery — 24; 20; 3; 6 Participants
N/A N=51 Spinery® A Novel Radio-Frequency Tumor Ablation Device for Spine Metastatic Tumors
Vertebral Metastasis
Primary: Change From Baseline in Worst Pain and Quality of Life Scores at 3 Months Using the Brief Pain Inventory (BPI) and EQ-5D-5L Questionnaires — 3.4; 65.2 points on a…