Degenerative Disc Disease Clinical Trial
Official title:
Clinical Trial on Performance and Acceptance of a New Robotic Assistance System During Spinal Fusion Surgery
The main objectives of the study are to evaluate the acceptance into operating flow, performance and safety of the AQrate Robotic Assisted System during the spinal fusion surgery
Based on the literature review of similar devices and on the pre-clinical tests performed
with the AQrate System on bench and cadavers, the study is build around the following
hypothesis:
1. The design and principle of operation of the AQrate System permits a correct
integration in the surgical procedure flow thus enabling the surgeon to benefit from
its advantages while not generating any additional operational difficulties
2. The stability and ease of use of the device will permit the surgeon to achieve any
planned spinal fusion without requiring additional assistance from the medical staff
compared to a conventional spinal fusion surgery.
3. A spinal fusion surgery procedure that is performed with the use of the AQrate System
is similar to conventional spinal fusion surgery. If correctly used, no additional
adverse event should be observed.
4. The exposure to x-ray should decrease as the need of intraoperative recheck of pedicle
screws placed should be reduced
5. The precision of placement of pedicle screw should not be adversely affected by the use
of the system compared to conventional spinal surgery.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| 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| Withdrawn |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 |
NCT02104167 -
Retrospective/Prospective Data Collection on the LDR ROIC Interbody Fusion Device With VerteBRIDGE Plating
|
||
| Completed |
NCT00965380 -
Trinity Evolution in Posterior or Transforaminal Lumbar Interbody Fusion (PLIF/TLIF)
|
||
| 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 |
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 | |
| Recruiting |
NCT04930211 -
Lumbar Transforaminal Anterior Epidural Steroid Injections in Discogenic Low Back Pain
|
N/A |