Clinical Trials Logo
  1. Home
  2. Degenerative Disc Disease
  3. NCT03223701

Efficacy of Using Solum IV and BMC With GFC in TLIF

Degenerative Disc Disease Clinical Trial

Official title:
Efficacy Study Using Solum IV, Bone Marrow Concentrate With General Fluid Concentrate in Transforaminal Lumbar Interbody Fusion

Clinical Trial Summary

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).

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03223701
Study type Interventional
Source Seton Healthcare Family
Contact
Status Withdrawn
Phase Phase 4
Start date September 30, 2017
Completion date December 30, 2018
View Details
See also
  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 NCT00965380 - Trinity Evolution in Posterior or Transforaminal Lumbar Interbody Fusion (PLIF/TLIF)
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 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