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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


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

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