Clinical Study With a Robotic Assistant in Patients Requiring a Spinal Transpedicular Fixation

Launched by CYBER SURGERY S.L. · Nov 22, 2023

Keywords

ClinConnect Summary

Multicenter non-comparative clinical trial.

This interventional study aims to assess the safety and performance of a robotic assistant, based on a electromechanical tracking system, in patients requiring transpedicular screw fixation.The primary focus is on overcoming the limitations of traditional minimally invasive surgeries and enhancing the accuracy of pedicle screw placement, especially within the complex pedicle region adjacent to the spinal canal.

The study design is a prospective interventional trial conducted in two hospital centers in Spain, with two principal investigators lead...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient scheduled for spinal fusion Surgery requiring pedicle screw insertion.
• • Open or minimally invasive (MIS) technique.
• • Spinal regions: lumbar, thoracic and/or sacral (one patient may cover several regions).
• • Signed informed consent.
• Exclusion Criteria:
• • Paediatric patient (\< 18 years)
• • Pedicular Surgery history with screw insertion in the vertebra to be operated.
• • Any contraindication for the pedicular screw placement.
• • Severe scoliosis.
• • Severe osteoporosis.
• • Infection or neoplasia.
• • Obesity.
• • Pregnancy and lactancy.
• • Any other disease or disorder that, in the opinión of the neurosurgeron, may put the patient at risk or may influence the results of the study.
• • Simultaneous participation in other clinical studies.
• • For whatever reason, the Clinical protocol cannot be followed.
• • The patient is unable, or unwilling, to sign the informed consent.
• • Patients in emergency situation who are not legally able to participate in the study.