Degenerative Disc Disease Clinical Trial
Official title:
An Assessment of the Safety and Performance of the Modulus® ALIF System in Patients Undergoing Anterior Lumbar Interbody Fusion
The primary objective of this study is to evaluate the safety and performance of the Modulus ALIF System in patients undergoing anterior lumbar interbody fusion (ALIF) as measured by reported complications, radiographic outcomes, and patient-reported outcomes.
Patients considered for this study will have previously undergone surgery for their spinal condition according to the standard of care of the practitioner. All patients at a given site who meet eligibility requirements will be considered for participation in the study. Available progress notes, medical records, patient-reported outcomes, radiographs (plain film and CT scans, if available), and complications will be obtained from the medical records of all enrolled subjects. The complication profile and overall performance of the Modulus ALIF System will be assessed using the following: 1. Complications attributable to the use of the Modulus ALIF System as noted in surgical summaries, progress notes, and hospital records; and 2. Radiographic outcome (fusion) and description of device status from available plain film radiographs and CT scan(s); and 3. Neurologic status, symptoms, and/or subject self-reported clinical outcomes (e.g., pain and disability), as available ;
| 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| Withdrawn |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 |