Clinical Trials Logo
  1. Home
  2. Lumbar Degenerative Disc Disease
  3. NCT05516992

Moderate - Severe Degenerative Disc Disease Evaluation of the Lumbar Spine — MODEL  

Lumbar Degenerative Disc Disease Clinical Trial

Official title:
A Phase 3, Multi-center, Randomized, Double-blind, Placebo-controlled Study, to Evaluate the Safety and Efficacy of SB-01 For Injection for the Treatment of Lumbar Degenerative Disc Disease

Clinical Trial Summary

The purpose of the study is to confirm the safety and effectiveness of SB-01 For Injection in adult patients with chronic low back pain and related disability due to Lumbar Degenerative Disc Disease. The primary effectiveness hypothesis is superiority of the investigational product relative to control in terms of the percentage of subjects improving in pain-related disability.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05516992
Study type Interventional
Source Spine BioPharma, Inc
Contact Pamela Zicker, NP
Phone 831-239-4115
Email pzicker@spinebiopharma.com
Status Recruiting
Phase Phase 3
Start date August 19, 2022
Completion date June 1, 2025
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
Completed NCT01640977 - A Prospective Non-concurrent Controlled Evaluation of Open and MAS® PLIF N/A
Terminated NCT01689922 - The Effectiveness of Anti-Gravity Treadmill Training 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 NCT01293981 - Radiographic and Clinical Outcomes of PureGen in Posterior Lumbar (PLIF) and Transforaminal Interbody Fusion (TLIF) N/A
Terminated NCT01294007 - Radiographic Analysis Using PureGen Versus Autologous Bone in Posterolateral Fusion (PLF) 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
Completed NCT01323387 - Lumbar Degenerative Disc Disease Treated With Anterior Tension Band System (ATB) With ALIF/FRA Spacer N/A