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SPIRA™-A 3D and HCT/p DBM vs. Medtronic Divergent™-L/Perimeter™ and Recombinant BMP-2

Degenerative Disc Disease Clinical Trial

Official title:
SPIRA™-A 3D Printed Titanium Anterior Lumbar Interbody Fusion Device and HCT/p Demineralized Bone Matrix Versus Medtronic Divergent™-L/Perimeter™ PEEK Anterior Lumbar Interbody Fusion Device and Recombinant Bone Morphogenic Protein-2

Clinical Trial Summary

A prospective, randomized, controlled clinical evaluation utilizing the SPIRA™ ALIF 3-D printed titanium interbody device with DBM vs a Medtronic PEEK ALIF interbody device with BMP

Clinical Trial Description

This is a single blinded randomized 1:1, controlled, prospective clinical study to evaluate fusion status and patient reported outcomes in circumferential lumbar fusion between L2-S1 at a single level with posterior screw fixation (Camber Spine Orthros System) and anterior surgery consisting of one of the treatment groups: subjects treated with the SPIRA™-A Interbody Device and HCTP/p DBM or subjects treated with Medtronic Divergent-L or Perimeter™ PEEK ALIF Interbody Device and rhBMP-2 (6mg per level). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04566874
Study type Interventional
Source Camber Spine Technologies
Contact Donald W Guthner, BS
Phone 646.460.2984
Email dguthner@cambermedtech.com
Status Recruiting
Phase N/A
Start date July 13, 2020
Completion date July 2021
View Details
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