Degenerative Disc Disease Clinical Trial
Official title:
An Assessment of the Safety and Performance of the Modulus® 3D-printed Titanium Interbody Implant in Patients Undergoing eXtreme Lateral Interbody Fusion (XLIF®)
The primary objective of this study is to evaluate the safety and performance of the Modulus 3D-printed titanium interbody implant in patients undergoing thoracic and/or lumbar XLIF 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 asked to consent to participate in the study. Once enrolled in the study, subjects will undergo a computed tomography (CT) scan at 12 months postoperative or later to evaluate their fusion status. If the patient already had a postoperative CT scan at 12 months or greater, this will be used in this study and an additional CT scan should not be performed for this 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 safety and performance of the Modulus XLIF interbody implant will be assessed using the following: 1. Complications attributable to the use of the Modulus XLIF interbody implant as noted in surgical summaries, progress notes, and hospital records 2. Radiographic outcome (fusion) and description of device status from plain film radiographs and CT scan(s) 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| Withdrawn |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
|
||
| 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)
|
||
| Terminated |
NCT00974623 -
Bone Graft Materials Observational Registry
|
N/A | |
| 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 |