Evaluation of Safety of Complex Pedicle Screw Trajectories Using Patient-Specific Guides (MySpine, Medacta) (Red Screws)

August 24, 2026 updated by: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Retrospective Assessment of the Safety and Accuracy of Pedicle Screw Placement Using Patient-Specific Guides (MySpine, Medacta): Standard Versus Anatomically Complex ("Red Screw") Trajectories

This retrospective, single-center observational study evaluates the clinical safety and neurophysiological performance of patient-specific MySpine guides (Medacta International) for pedicle screw placement in patients undergoing instrumented spinal surgery. Particular attention is focused on anatomically complex trajectories identified during preoperative planning as "Red Screws," in which complete osseous containment of the planned screw trajectory cannot be ensured because of dysplastic, hypoplastic, or otherwise challenging pedicle anatomy.

The study includes 130 patients treated between January 2015 and January 2026, encompassing a total of 2,626 pedicle screws. The primary objective is to compare the incidence of positive triggered electromyography responses, defined as a stimulation threshold <8 mA, between standard screws and Red Screws.

Secondary objectives are to compare absolute stimulation thresholds, screw-related intraoperative neuromonitoring alerts, the need for screw repositioning or removal, and postoperative neurological deficits considered related to screw placement. An exploratory analysis will also investigate whether a planned medial cortical breach is associated with an increased risk of neurophysiological warning signals or other intraoperative screw-related events.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

130

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • MI
      • Milan, MI, Italy, 20132
        • IRCCS Ospedale Galeazzi-Sant'Ambrogio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

The study population includes 130 patients who underwent instrumented spinal surgery using MySpine patient-specific guides at IRCCS Ospedale Galeazzi-Sant'Ambrogio between January 2015 and January 2026. Both pediatric and adult patients were included. The analysis comprised 2,626 pedicle screws with complete screw-level planning and intraoperative neurophysiological data.

Description

Inclusion Criteria:

  • Patients, both adults and minors, who underwent instrumented spinal surgery using MySpine guides at IRCCS Galeazzi - Sant'Ambrogio Hospital between January 1, 2015, and January 31, 2026.

Exclusion Criteria:

  • Incomplete clinical documentation
  • Procedures performed without using MySpine guides

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of positive neurophysiological stimulation,
Time Frame: Along the surgery time (especially during pedicle screw placement)
compare the incidence of positive neurophysiological stimulation, defined as a stimulation threshold below 8 mA, between standard-trajectory screws and "Red Screws."
Along the surgery time (especially during pedicle screw placement)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2026

Primary Completion (Actual)

August 14, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

August 24, 2026

First Submitted That Met QC Criteria

August 24, 2026

First Posted (Actual)

August 27, 2026

Study Record Updates

Last Update Posted (Actual)

August 27, 2026

Last Update Submitted That Met QC Criteria

August 24, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Red Screws

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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