Clinical Trials Logo
  1. Home
  2. Degenerative Disc Disease
  3. NCT04566874

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
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
Withdrawn NCT03223701 - Efficacy of Using Solum IV and BMC With GFC in TLIF Phase 4
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
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 NCT00965380 - Trinity Evolution in Posterior or Transforaminal Lumbar Interbody Fusion (PLIF/TLIF)
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