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

NCT ID: NCT06153511

Last Updated: 2023-12-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-16
• Study Completion Date: 2023-07-07

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 system, in patients requiring transpedicular screw fixation. The study, conducted in two different hospital centers, involves patients with vertebral fractures, spinal stenosis, kyphosis, and other related conditions. The primary objective is to determine screw accuracy by assessing the degree of screw invasion into the pedicle using the Gertzbein-Robbins scale, with a target of achieving 96% acceptable screw placement. Trained radiologists will evaluate the screw invasion into the pedicle. The study is scheduled to span 12 months and each intervention includes a 1-month follow-up. Throughout this time frame, patients will undergo regular assessments, and outcomes will be closely monitored.

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 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 leading the investigation. Patients requiring transpedicular screw fixation will be recruited. The robotic assistant will be employed to facilitate transpedicular screw fixation. The system aims to improve accuracy and safety in screw placement, in comparison with conventional techniques used.

Patients will include individuals with spinal fractures, spinal stenosis, kyphosis, and other conditions requiring transpedicular screw fixation. Two principal investigators in Spain will lead the recruitment process.

The study aims to answer several key questions:

• Determine Screw Accuracy: Assess the degree of screw invasion into the pedicle using the Gertzbein-Robbins scale, with a target of achieving 96% acceptable screw placement.
• Evaluate Planning vs. Final Screw Placement: Determine the accuracy of screw placement by comparing planned positions with the actual final positions.
• System Performance: Assess the overall performance of the robotic system during the surgical procedure.
• Reoperation and Postoperative Time: Determine the need for reoperation and evaluate postoperative recovery time.
• Adverse Events: Detect and document any adverse events occurring during the surgical process.

Trained radiologists will play a crucial role in evaluating the accuracy of screw placement, focusing on the degree of invasion into the pedicle using the Gertzbein-Robbins scale. The study is set to span a duration of 12 months,during which patients will undergo regular assessments, and outcomes will be closely monitored. The inclusion of the electromechanical tracking system in the robotic assistant adds a technological dimension to the investigation, contributing to advancements in the field of minimally invasive spinal surgeries.

Conditions

SPINAL Fracture; Vertebral Fractures; Spinal Stenosis; Kyphosis; Lumbar Spinal Stenosis; Thoracolumbar Kyphosis

Keywords

Robot assisted spinal fusion

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Patient with spinal condition who requires a transpedicular fixation intervention.

Patient with spinal condition (vertebral fractures, spinal stenosis, kyphosis, among others) who requires a intervention for spinal fusion with pedicle screws.

Group Type: EXPERIMENTAL

Robot assisted spinal transpedicular fixation

Intervention Type: PROCEDURE

Surgical technique which joins two or more vetebrae with screws and rods to prevent any relative movement between them. It is a major surgery that usually lasts several hours and in which the patient is subjected to general anesthesia. The screws to be placed go through a narrow area of the vertebra known as the pedicle. Each patient will undergo a singular intervention.

Interventions

Robot assisted spinal transpedicular fixation

Surgical technique which joins two or more vetebrae with screws and rods to prevent any relative movement between them. It is a major surgery that usually lasts several hours and in which the patient is subjected to general anesthesia. The screws to be placed go through a narrow area of the vertebra known as the pedicle. Each patient will undergo a singular intervention.

Intervention Type: PROCEDURE

Other Intervention Names

Robotic assisted pedicle screw insertion

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cyber Surgery S.L.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicolás M. Samprón Lebed, Neurosurgeon

Role: PRINCIPAL_INVESTIGATOR

Hospital Donostia

Iñigo C. Pomposo Gastelu, Neurosurgeon

Role: PRINCIPAL_INVESTIGATOR

Hospital de Cruces

Locations

Cyber Surgery

Donostia / San Sebastian, Gipuzkoa, Spain

Countries

Spain

Other Identifiers

PROTCL-CYB-01-PIC

Identifier Type: -

Identifier Source: org_study_id