Degenerative Disc Disease Clinical Trial
Official title:
Efficacy Study Using Solum IV, Bone Marrow Concentrate With General Fluid Concentrate in Transforaminal Lumbar Interbody Fusion
The purpose of this study is to examine the efficacy of using Solum IV and bone marrow concentrate with general fluid concentrate in Transforaminal Lumbar Interbody Fusion (TLIF).
This is a prospective, single-center clinical study. Ten patients will be enrolled and
undergo an TLIF with a spinal fixation system and receive Solum IV (Celling Biosciences) and
patient's BMC with GFC.
The bone marrow aspirate (BMA) will be taken from the iliac crest of the enrolled subjects.
The BMA will be transferred to a processor that will use ART BMC Plus (Celling Biosciences,
Austin, TX) platform technology to obtain the BMC preparation. The plasma component that
remains as a by-product of generating the BMC will then be concentrated by the ART BMC Plus
device to create a concentrated plasma/general fluid concentrate (GFC). The enrolled
subjects' BMC and GFC will be provided to the principle investigator who will combine the two
together with Solum IV using the Graft Delivery Kit (Celling Biosciences) and perform a TLIF
procedure. (See Appendix B for Graft Delivery Kit). All subjects will be assigned to receive
lumbar interbody fusion via a TLIF approach with Solum IV bone graft and BMC with GFC in the
interbody space of a TLIF using cynch bullet cage (@SpineSmith) and Stryker based pedicle
screw system (Xia 3 system).
All study subjects will be assessed for fusion rate, complication rates and subject-reported
outcomes at designated intervals up to 12 months after surgery. X-rays (anterior-posterior,
lateral, flexion-extension) will be taken at pre-operatively, 3, 6, and 12 months
post-treatment.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04848376 -
Post-Market Clinical Follow-up Study of A-SPINE's Products
|
||
Active, not recruiting |
NCT05114135 -
TLIF Osteo3 ZP Putty Study (Also Known as the TOP Fusion Study)
|
N/A | |
Suspended |
NCT04735185 -
Stem Cells vs. Steroids for Discogenic Back Pain
|
N/A | |
Completed |
NCT04057235 -
Retrospective Review of Integrity Implants FlareHawk® for Lumbar Fusion
|
||
Not yet recruiting |
NCT06000319 -
Natural Matrix Protein™ (NMP™) Fibers in Cervical and Lumbar Interbody Fusion
|
||
Active, not recruiting |
NCT02969616 -
Trinity Elite in Lumbar Fusion
|
||
Completed |
NCT02558621 -
New Robotic Assistance System for Spinal Fusion Surgery
|
N/A | |
Completed |
NCT02104167 -
Retrospective/Prospective Data Collection on the LDR ROIC Interbody Fusion Device With VerteBRIDGE Plating
|
||
Completed |
NCT00996073 -
Safety and Preliminary Efficacy Study of NeoFuse in Subjects Requiring Lumbar Interbody Fusion
|
Phase 2 | |
Completed |
NCT00965380 -
Trinity Evolution in Posterior or Transforaminal Lumbar Interbody Fusion (PLIF/TLIF)
|
||
Terminated |
NCT00974623 -
Bone Graft Materials Observational Registry
|
N/A | |
Completed |
NCT00758719 -
Evaluate Effectiveness of the Biomet Lumbar Spinal Fusion System
|
||
Completed |
NCT00165893 -
Comparison of IDD Therapy and Non-surgical Treatment for Low Back Pain Caused by Degenerative Disc Disease
|
Phase 4 | |
Terminated |
NCT01494493 -
Pivotal Study of rhBMP-2/ACS/Allograft Bone Dowel for Anterior Lumbar Interbody Fusion in Patients With Symptomatic Degenerative Disc Disease
|
N/A | |
Recruiting |
NCT04727385 -
Intervertebral DXM Gel Injection in Adults With Painful Lumbar Degenerative Disc Disease
|
N/A | |
Completed |
NCT04849429 -
Intra-discal Injection of Platelet-rich Plasma (PRP) Enriched With Exosomes in Chronic Low Back Pain
|
Phase 1 | |
Recruiting |
NCT04469387 -
Preventive Effect of Limited Decompression on Adjacent Segment Following Posterior Lumbar Interbody Fusion
|
N/A | |
Recruiting |
NCT04056520 -
Clinical and Radiological Outcomes of Posterior Cervical Fusion With Medtronic Infinity Occipitocervical-Upper Thoracic (OCT) System
|
||
Completed |
NCT04119466 -
Stabilizing Training in Degenerative Disc Disease
|
N/A | |
Recruiting |
NCT04930211 -
Lumbar Transforaminal Anterior Epidural Steroid Injections in Discogenic Low Back Pain
|
N/A |