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SPINAL FractureNCT06153511

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

A study testing Robot assisted spinal transpedicular fixation in people with SPINAL Fracture and Vertebral Fractures, run by Cyber Surgery S.L. at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
Robot assisted spinal transpedicular fixation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
1 siteSpain
Study dates
16 Nov 2022to 7 Jul 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 13Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Cyber Surgery

    Donostia / San Sebastian, Gipuzkoa, 20001

Other trials in Spain

About this study

Official title: Clinical Investigation With a Robotic Assistant for Spinal Surgery in Patients Requiring a Transpedicular Fixation

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.

Read the 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.

Being tested
Robot assisted spinal transpedicular fixation
Keywords
Robot assisted spinal fusion
Medical subject headings
Spinal Fractures, Spinal Stenosis, Kyphosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Robot assisted spinal transpedicular fixationProcedure or surgery

    Also called Robotic assisted pedicle screw insertion

    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.

Study groups in NCT06153511
Study groupRoleWhat they receive
Patient with spinal condition who requires a transpedicular fixation intervention.ExperimentalPatient with spinal condition (vertebral fractures, spinal stenosis, kyphosis, among others) who requires a intervention for spinal fusion with pedicle screws.
Receives: Procedure: Robot assisted spinal transpedicular fixation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 month follow-up

Secondary outcomes (43)

  1. Patient characteristics - Demographic dates - Sex (Male/Female)

    Measured: 3 months

  2. Patient characteristics - Demographic dates - Age (years)

    Measured: 3 months

  3. Patient characteristics - Demographic dates - Weight (kg)

    Measured: 3 months

  4. Patient characteristics - Demographic dates - Height (cm)

    Measured: 3 months

  5. Patient characteristics - BMI

    W [kg]/H [m2]

    Measured: 3 months

  6. Patient characteristics - Spinal Region (Thoracic/Lumbar/Sacral)

    Measured: 3 months

  7. Patient characteristics - Vertebrae for study (T1...T12/L1...L5/S1-S2)

    Measured: 3 months

  8. Patient characteristics - Comobidities

    Charlson Index (1-6 pts)

    Measured: 3 months

  9. Patient characteristics - Number of screws to be placed

    Measured: 3 months

  10. Implant characteristics - Planned vertebrae

    Measured: 3 months

  11. Implant characteristics - Laterality (L/R)

    Measured: 3 months

  12. Implant characteristics - Screw orientation in sagittal plane (Cranial/Caudal/Neutral)

    Measured: 3 months

  13. Implant characteristics - Screw orientation in axial plane (Medial/Lateral/Neutral)

    Measured: 3 months

  14. Implant characteristics - Screw dimensions - Screw diameter (mm)

    Measured: 3 months

  15. Implant characteristics - Screw dimensions - Screw length (mm)

    Measured: 3 months

  16. Clinical Intervention - Surgical technique (open/MIS)

    Measured: 3 months

  17. Clinical Intervention - ASA Anaesthesia (I-IV)

    Measured: 3 months

  18. Clinical Intervention - Radiation emission - Time (sec.)

    Measured: 3 months

  19. Clinical Intervention - Radiation emission - Dosage (mGy)

    Measured: 3 months

  20. Clinical Intervention - Blood loss - Intraoperatice blood loss (ml)

    Measured: 3 months

  21. Clinical Intervention - Blood loss - Number of gauzes used

    Measured: 3 months

  22. Clinical Intervention - Blood loss - Postoperative drainage (ml)

    Measured: 3 months

  23. Clinical Intervention - Blood loss - Duration of surgery - Total (min.)

    Measured: 3 months

  24. Clinical Intervention - Blood loss - Duration of surgery per stages - Power on and disposition (min.)

    Measured: 3 months

  25. Clinical Intervention - Blood loss - Duration of surgery per stages - Planification (min.)

    Measured: 3 months

  26. Clinical Intervention - Blood loss - Duration of surgery per stages - Image registration (min.)

    Measured: 3 months

  27. Clinical Intervention - Blood loss - Duration of surgery per stages - Positioning (min.)

    Measured: 3 months

  28. Clinical Intervention - Blood loss - Duration of surgery per stages - Surgery (min.)

    Measured: 3 months

  29. Clinical Intervention - Blood loss - Duration of surgery per stages - Removal and power off (min.)

    Measured: 3 months

  30. Clinical Intervention - Blood loss - Postoperative stay (days)

    Measured: 1 month follow-up

  31. System performance - Number of image registration

    Measured: 1 month follow-up

  32. System performance - Number of screws not inserted using the robotic assistant

    Measured: 1 month follow-up

  33. System performance - Number of colisioned screws

    Measured: 1 month follow-up

  34. System performance - Number of not reachable screws

    Measured: 1 month follow-up

  35. System performance - Fiducial Registration Error, FRE (mm)

    Measured: 3 months

  36. System performance - Screw position deviation - Spatial deviation in XY plane (mm)

    Measured: 1 month follow-up

  37. System performance - Screw position deviation - Spatial deviation in XZ plane (mm)

    Measured: 1 month follow-up

  38. System performance - Screw position deviation - Spatial deviation in YZ plane (mm)

    Measured: 1 month follow-up

  39. System performance - Screw position deviation - Angular deviation in XY plane (deg.)

    Measured: 1 month follow-up

  40. System performance - Screw position deviation - Angular deviation in XZ plane (deg.)

    Measured: 1 month follow-up

  41. System performance - Screw position deviation - Angular deviation in YZ plane (deg.)

    Measured: 1 month follow-up

  42. Adverse Events, AE

    Measured: 1 month follow-up

  43. Severe Adverse Events, SAE

    Measured: 1 month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Dec 2023
  2. Study start16 Nov 2022
  3. Primary completion24 Apr 2023
  4. Study completion7 Jul 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06153511
Sponsor's protocol ID
PROTCL-CYB-01-PIC
Status last verified
Nov 2023
First submitted
16 Nov 2023
Last updated
1 Dec 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Robot assisted spinal transpedicular fixation in people with SPINAL Fracture and Vertebral Fractures, run by Cyber Surgery S.L. at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Grade of screw invasion into the pedicle based on Gertzbein-Robbins scale (A-E grade) (time frame: 1 month follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06153511.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2023.

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