Adaptix RCT Evaluating Adaptix™ Versus PEEK Cages
Spinal Canal StenosisSpondylolisthesis3 moreThe purpose of this randomized controlled trial is to assess and compare radiographic and clinical outcomes in patients who are to undergo combined interbody/posterolateral lumbar fusion procedures, supplemented with pedicle screw instrumentation, using one of the following interbody cages; the Medtronic Adaptix™ cage with roughened micro and nano-textured titanium surfaces or the CAPSTONE® poly-ether-ether-ketone cage.
Regional Anesthesia in Minimally Invasive Lumbar Spine Surgery
Lumbar Spinal StenosisLumbar Disc Herniation8 moreOpioid overuse is a widespread public health crisis in the United States with increasing rates of addiction and overdose deaths from prescription opioids. Reducing the need for opiate analgesics in the post-operative setting has become a high priority in minimizing long-term opioid use in surgical patients. This study will serve to demonstrate the efficacy of the addition of regional analgesic techniques in reducing post-operative opioid requirements in patients undergoing common lumbar spinal surgical procedures.
Clinical Outcomes Associated With the Use of ViviGen® for the Treatment of Lumbar Degenerative Disc...
Lumbar SpondylolisthesisDegenerative Disc Disease4 moreThe objective of this study is to perform a prospective, randomized, controlled clinical trial to compare radiographic fusion rates and patient reported outcomes, including pain and function preoperatively and postoperatively, using Depuy ViviGen® Cellular Bone Matrix mixed with cortical/cancellous allograft in conjunction with an approved Depuy Synthes pedicle screw system compared to autograft mixed with cortical/cancellous allograft in conjunction with the same DePuy Synthes pedicle screw system used for a one or two - level posterolateral lumbar fusion.
A Clinical Study to Evaluate Safety and Performance of PEEK-OPTIMA™ HA Enhanced.
Degenerative Disc DiseaseSpondylolisthesis1 moreThe purpose of this trial is to collect clinical outcomes including radiographic and CT outcomes in patients who undergo spinal fusion using the Keos Lumbar Interbody Fusion Device.
Denosumab vs Zoledronate After Lumbar Fusion
OsteopeniaLumbar SpondylolisthesisThe aim of the study was to compare denosumab and zoledronate efficacy in bone mass, bone turnover markers (BTMs), Visual Analogue Scale (VAS) for leg and back, EuroQol Five-Dimension (EQ-5D) scores, Quality of Life Questionnaire of the European Foundation for Osteoporosis-31 (QUALEFFO-31) scores, and Roland-Morris Disability Functioning Questionnaire (RMDQ) scores, secondary fracture, complications and adverse events after lumbar fusion.
Liposomal Bupivacaine in One-level Instrumented Posterior Spinal Fusion
Lumbar Spinal StenosisLumbar Disc Herniation2 moreThis study will describe postoperative pain management for spine surgery patients receiving liposomal bupivacaine (Exparel®) compared to patients not receiving the drug.
Rate of Bony Fusion Using NanoBone® Synthetic Bone Graft Versus Local Autologous Bone Graft.
Degenerative Disc DiseaseSpondylolisthesisThe objectives of this longitudinal study are to assess and measure fusion status (fused or not fused) and rate of bony fusion using NanoBone® Synthetic Bone Graft in patients requiring one to two level lumbar posterolateral fusion procedures with or without commercially available rigid spinal instrumentation. Our hypothesis is that the Nanobone synthetic bone graft will be as effective at creating a fusion in the lumbar spine as compared with a local bone graft. Each subject will serve as their own control during this study, as patients will receive the Nanobone graft on the right side of their spine and the local bone graft on their left side.
Methadone for Spinal Fusion Surgery.
PainPostoperative6 moreA prospective double-blind, randomized controlled trial investigating the effect of a single-dose of intraoperative methadone in patients undergoing spinal fusion.
OSTEOAMP Lumbar Fusion Intra-Patient Controlled Study
Lumbar Spine DiseaseLumbar Spondylolisthesis3 moreThe objective of this clinical study is to compare OSTEOAMP SELECT Fibers to Infuse Bone Graft, in terms of effectiveness and safety, when used as a bone graft substitute in in skeletally mature patients qualified for 2-lumbar interbody fusion (LIF) by means of an intra-patient control model.
Single-Armed Use of ViviGen Cellular Bone Matrix in Patients Undergoing Posterolateral Lumbar Surgery...
Degenerative Disc DiseaseSpinal Stenosis2 moreThis is a prospective, single-arm post market study of patients to assess fusion in one or multiple continuous levels of the lumbosacral spine (L1-S1) using ViviGen Cellular Bone Matrix. All subjects will be followed out to 24 months for final assessment.