Clinical Trials Logo
  1. Home
  2. Lumbar Degenerative Disc Disease
  3. NCT02347410

Spineology Clinical Outcomes Trial: An IDE Investigation — SCOUT  

Lumbar Degenerative Disc Disease Clinical Trial

Official title:
Spineology Clinical Outcomes Trial: An Investigation Device Exempt (IDE) Performance Goal Clinical Investigation

Clinical Trial Summary

This study evaluated the safety and effectiveness of the Spineology Interbody Fusion System (SIFS) in an instrumented interbody lumbar fusion in subjects presenting with symptomatic single-level lumbar degenerative disc disease.

Clinical Trial Description

This regulated prospective, multi-center, Institutional Review Board (IRB) approved single-arm performance goal clinical investigation was conducted at 10 centers with 102 subjects being enrolled and treated. Subjects were actively evaluated from pre-op to 24-months postoperative. Based on enrollment duration, some subjects were remotely assessed through self-administered surveys at 36- and/or 48-months. The primary endpoint, assessed at 24-months postoperative, is a composite score that includes pain, function, fusion and safety assessments. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02347410
Study type Interventional
Source Spineology, Inc
Contact
Status Completed
Phase N/A
Start date January 22, 2015
Completion date March 4, 2020
View Details
See also
  Status Clinical Trial Phase
Completed NCT01198470 - TRIUMPH Lumbar Artificial Disc IDE: A Pilot Study N/A
Terminated NCT00744861 - Ultrasound as Adjunct Therapy for Increasing Fusion Success After Lumbar Surgery N/A
Completed NCT00949936 - Safety and Performance Study of the CAdiscTM-L Lumbar Spinal Disc Replacement Device For CE Marking N/A
Completed NCT03974711 - Rampart Duo Clinical (RaDical) Post-Market Study
Recruiting NCT01721889 - Radiostereometric Analysis of Spine Arthrodesis N/A
Terminated NCT02139527 - CARES Lumbar Artificial Disc Registry Phase 4
Terminated NCT00878579 - Percutaneous Dynamic Stabilization (PDS) System Versus Fusion for Treating Degenerative Disc Disease Phase 2
Terminated NCT01689922 - The Effectiveness of Anti-Gravity Treadmill Training N/A
Completed NCT01640977 - A Prospective Non-concurrent Controlled Evaluation of Open and MAS® PLIF N/A
Enrolling by invitation NCT02529566 - Human Autograft Mesenchymal Stem Cell Mediated Stabilization of The Degenerative Lumbar Spine N/A
Terminated NCT02070484 - Human Amniotic Tissue-derived Allograft, NuCel, in Posteriolateral Lumbar Fusions for Degenerative Disc Disease N/A
Terminated NCT01294007 - Radiographic Analysis Using PureGen Versus Autologous Bone in Posterolateral Fusion (PLF) N/A
Terminated NCT01293981 - Radiographic and Clinical Outcomes of PureGen in Posterior Lumbar (PLIF) and Transforaminal Interbody Fusion (TLIF) N/A
Terminated NCT00640029 - Evaluation of the Prosthetic Disc Replacement N/A
Terminated NCT00456378 - Study of the Safety and Effectiveness of DIAM™ Spinal Stabilization System Versus Conservative Care N/A
Completed NCT03647501 - Lumbar Fusion With Nexxt Spine 3D-Printed Titanium Interbody Cages N/A
Active, not recruiting NCT02297256 - Prospective Study of Thoracolumbar Spinal Fusion Graft N/A
Recruiting NCT05516992 - Moderate - Severe Degenerative Disc Disease Evaluation of the Lumbar Spine Phase 3
Completed NCT01323387 - Lumbar Degenerative Disc Disease Treated With Anterior Tension Band System (ATB) With ALIF/FRA Spacer N/A