Status:
COMPLETED
Clinical Study With a Robotic Assistant in Patients Requiring a Spinal Transpedicular Fixation
Lead Sponsor:
Cyber Surgery S.L.
Conditions:
SPINAL Fracture
Vertebral Fractures
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
This multicenter, non-comparative clinical trial, led by two principal investigators in Spain, aims to evaluate the safety and performance of a robotic assistant, based on a electromechanical tracking...
Detailed Description
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 requi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 16 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 7 2023
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT06153511
Start Date
November 16 2022
End Date
July 7 2023
Last Update
December 1 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Cyber Surgery
Donostia / San Sebastian, Gipuzkoa, Spain, 20001