Clinical Trials Logo
  1. Home
  2. Lumbar Degenerative Disc Disease
  3. NCT03974711

Rampart Duo Clinical (RaDical) Post-Market Study — RaDical  

Lumbar Degenerative Disc Disease Clinical Trial

Official title:
Rampart Duo Clinical (RaDical) Study: An Exempt Minimal Risk Post-Market Evaluation of Clinical Outcomes

Clinical Trial Summary

This exempt, minimal risk, prospective, post-market, registry, multi-center, Institution Review Board (IRB) approved observational clinical evaluation was conducted at 10 centers. A total of 197 patients were enrolled. The evaluation collected data in a real-world patient population and was a data collection initiative only. No patient treatments or care were performed as a component of the protocol. All patient care received was on-label and standard of care for lateral lumbar interbody fusions. The data collected in this evaluation is intended to contribute to the body of literature for lateral lumbar interbody fusions.

Clinical Trial Description

The purpose of this study was to collect data that reports on the clinical outcomes of patients that were treated with the Spineology Rampart DUO device in a standard of care instrumented lateral lumbar interbody fusion procedure at one or two contiguous levels from L2-L5. Data was collected prospectively at specified time points per protocol and included both objective and subjective measures. The study concluded when the final patient achieved their 12-month evaluation. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03974711
Study type Observational [Patient Registry]
Source Spineology, Inc
Contact
Status Completed
Phase
Start date October 2, 2017
Completion date October 3, 2022
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
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
Completed NCT02347410 - Spineology Clinical Outcomes Trial: An IDE Investigation 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