MySpine MC Versus MySpine Standard — MC vs STD  

Degenerative Disc Disease Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

Adult subjects, among those whose clinical condition makes them eligible for a spinal stabilization and meeting the inclusion/exclusion 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. ;

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Intervertebral Disc Degeneration
• Spondylolysis

• NCT number: NCT05846477
• Study type: Observational
• Source: Medacta International SA
• Contact: Elisa Bonacina, PhD
• Phone: +41 91 696 60 60
• Email: bonacina@medacta.ch
• Status: Recruiting
• Start date: February 4, 2021
• Completion date: February 28, 2024