Clinical Study With a Robotic Assistant in Patients Requiring a Spinal Transpedicular Fixation
Condition: SPINAL Fracture; Vertebral Fractures; Spinal Stenosis; Kyphosis; Lumbar Spinal Stenosis; Thoracolumbar Kyphosis
MeSH terms: Spinal Stenosis; Kyphosis; Constriction, Pathologic; Fractures, Bone; Spinal Fractures
Study type: Interventional

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.
    

Intervention name(s): Robot assisted spinal transpedicular fixation
Intervention type(s): Procedure
Intervention description(s): 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.
Other intervention name(s): Robotic assisted pedicle screw insertion
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Robot assisted spinal fusion