Spinal Stenosis Clinical Trial
Official title:
A Prospective Randomized Clinical Investigation of Posterolateral Lumbosacral Spinal Fusions With BMP-2 and Titanium Pedicle Screw Instrumentation Versus BMP-2 Alone.
The goal of spinal fusion is to relieve pain and/or increase stability in painful or
unstable spine joints. A patient may or may not receive rods and screws with the use of bone
graft materials to facilitate bone growth and a fusion thus preventing movement of the bones
of the spine.
In this research study, bone graft substitute material called Bone Morphogenetic Protein-2
known as BMP-2 Infuse will be used. No hip bone will be used. The surgical procedure will
consist of BMP-2 Infuse with or without the use of rods and screws.
In this study we will be using BMP-2 Infuse instead of the iliac crest bone graft for the
spinal fusion. The BMP-2 Infuse has been researched in the only completed clinical trial for
spinal fusions. It has demonstrated equivalence to the iliac crest bone graft with regard to
both fusion rate and clinical outcome.
Currently, the acceptable standard of care for spinal fusion surgery requires instrumented
or non-instrumented procedure with the use of bone graft materials, to facilitate bone
growth, and a fusion, thus eliminating movement between the inciting vertebrae.
In this study, the surgical procedure will be BMP-2 Infuse with instrumentation or BMP-2
Infuse alone.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT06290908 -
RPE-P/TLIF for Lumbar Spinal Stenosis With Instability
|
||
| Withdrawn |
NCT03223701 -
Efficacy of Using Solum IV and BMC With GFC in TLIF
|
Phase 4 | |
| Recruiting |
NCT03883022 -
Vancomycin Powder Combined With Autogenous Bone Graft as a Prevention for Post-operative Infection for Spine Surgery
|
N/A | |
| Completed |
NCT02902380 -
The Effect of Dexmedetomidine on Neuroendocrine Stress Hormone Release and Heart Rate Variability in Patients Undergoing Major Spinal Surgery
|
N/A | |
| Not yet recruiting |
NCT06024785 -
Vertebropexy - Randomized-controlled Trial
|
N/A | |
| Not yet recruiting |
NCT06000319 -
Natural Matrix Protein™ (NMP™) Fibers in Cervical and Lumbar Interbody Fusion
|
||
| Completed |
NCT02558621 -
New Robotic Assistance System for Spinal Fusion Surgery
|
N/A | |
| Completed |
NCT02454400 -
Pre-surgery Physiotherapy for Patients With Specific Low Back Pain
|
N/A | |
| Completed |
NCT01377623 -
Pilot Study on the Effect of Dexmedetomidine on Inflammatory Responses in Patients Undergoing Lumbar Spinal Fusion
|
N/A | |
| Terminated |
NCT00974623 -
Bone Graft Materials Observational Registry
|
N/A | |
| Completed |
NCT00996073 -
Safety and Preliminary Efficacy Study of NeoFuse in Subjects Requiring Lumbar Interbody Fusion
|
Phase 2 | |
| Completed |
NCT00320619 -
Epsilon-Aminocaproaic Acid to Reduce the Need for Blood Transfusions During and Following Spine Surgery
|
N/A | |
| Completed |
NCT00022776 -
Surgical Versus Nonsurgical Treatment for Spinal Stenosis
|
Phase 3 | |
| Completed |
NCT06060821 -
Validity and Reliability of the 2-minute Step Test in Patients With Lumbar Spinal Stenosis
|
||
| Recruiting |
NCT04552145 -
Physical Therapy vs Surgical Decompression for Lumbar Spinal Stenosis
|
N/A | |
| Active, not recruiting |
NCT04379921 -
Improving Spine Surgical Care With Real-Time Objective Patient Tracking Using the Apple Watch
|
N/A | |
| Withdrawn |
NCT04315090 -
Post-surgical Outcomes Measure Using the ERAS Protocol for Posterior Cervical Decompression and Fusion
|
||
| Completed |
NCT04591249 -
Physical Activity Intervention for Patients Following Lumbar Spine Surgery
|
N/A | |
| Recruiting |
NCT04601363 -
Personalized Spine Study Group (PSSG) Registry
|
||
| Completed |
NCT04193488 -
Mid-Transverse Process to Pleural (MTP) Block and Erector Spinal Plan (ESP) Block in Spinal Surgery
|
N/A |