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

NCT06153511 | Completed DMC

• 1 other identifier: PROTCL-CYB-01-PIC
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Robot assisted spinal fusion

Outcome Measures

Primary Outcomes (1)

• Grade of screw invasion into the pedicle based on Gertzbein-Robbins scale (A-E grade)

  Grade A: Screw position within the pedicle. Grade B: Cortical breakage ≤2mm. Grade C: Cortical breakage ≤4mm. Grade D: Cortical breakage ≤6mm. Grade E: Cortical breakage \>6mm.

  1 month follow-up

Secondary Outcomes (43)

• Patient characteristics - Demographic dates - Sex (Male/Female)

  3 months

• Patient characteristics - Demographic dates - Age (years)

  3 months

• Patient characteristics - Demographic dates - Weight (kg)

  3 months

• Patient characteristics - Demographic dates - Height (cm)

  3 months

• Patient characteristics - BMI

  3 months

Study Arms (1)

Patient with spinal condition who requires a transpedicular fixation intervention.

EXPERIMENTAL

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

Procedure: Robot assisted spinal transpedicular fixation

Interventions

Robot assisted spinal transpedicular fixation 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.

Also known as: Robotic assisted pedicle screw insertion

Patient with spinal condition who requires a transpedicular fixation intervention.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cyber Surgery S.L.: lead

Study Sites (1)

Cyber Surgery

Donostia / San Sebastian, Gipuzkoa, 20001, Spain

Location

MeSH Terms

Conditions

Spinal Fractures; Spinal Stenosis; Kyphosis

Condition Hierarchy (Ancestors)

Spinal Injuries; Back Injuries; Wounds and Injuries; Fractures, Bone; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Spinal Curvatures

Study Officials

• Nicolás M. Samprón Lebed, Neurosurgeon

  Hospital Donostia

  PRINCIPAL INVESTIGATOR

• Iñigo C. Pomposo Gastelu, Neurosurgeon

  Hospital de Cruces

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2023
• First Posted: December 1, 2023
• Study Start: November 16, 2022
• Primary Completion: April 24, 2023
• Study Completion: July 7, 2023
• Last Updated: December 1, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)