Ignite Creation Date:
2024-05-06 @ 6:58 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05846477
Status:
RECRUITING
Last Update Posted:
2023-05-06
First Post:
2023-04-25
Brief Title:
MySpine MC Versus MySpine Standard
Sponsor:
Medacta International SA
Organization:
Medacta International SA
Study Overview
Official Title:
Prospective Comparative Monocentric Research Project Study to Compare Cortical Bone Trajectory Screw Insertion Technique With Pedicle Screw Insertion Technique by Use of Patient Specific Drill Guides
Status:
RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MC vs STD
Brief Summary:
This research project compares the clinical performance of the cortical bone trajectory CBT insertion technique with the current clinical Gold standard the Pedicle screw insertion technique Both techniques are performed by aid of MySpine patient-specific guide systems
Detailed Description:
Adult subjects among those whose clinical condition makes them eligible for a spinal stabilization and meeting the inclusionexclusion criteria will be invited to participate to the research project and ask to sign a consent in order to further use of personal and clinical data collected during standard practice visit
The primary objective of the research project is to compare clinical outcomes in terms of assessing the main outcomes of importance to patients with back problems pain function symptom-specific well-being quality of life disability of spine surgery with cortical bone trajectory screw placement technique respect the traditional pedicle screw placement technique Preoperative data and collected during visit as per standard routine at 6 weeks 3 6 and 12 months postop will be recoreded and assessed for the purpose of this research project
The primary objective of the research project is to compare clinical outcomes in terms of assessing the main outcomes of importance to patients with back problems pain function symptom-specific well-being quality of life disability of spine surgery with cortical bone trajectory screw placement technique respect the traditional pedicle screw placement technique Preoperative data and collected during visit as per standard routine at 6 weeks 3 6 and 12 months postop will be recoreded and assessed for the purpose of this research project
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None