Red Screws
Retrospective Assessment of the Safety and Accuracy of Pedicle Screw Placement Using Patient-Specific Guides (MySpine, Medacta): Standard Versus Anatomically Complex ("Red Screw") Trajectories
Sponsor study identifier
observational
130
1 country
1
Study Start
May 15, 2026
Actual (reported)Primary Completion
August 14, 2026
Actual (reported)Study Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 15, 2026
Actual (reported)August 14, 2026
Actual (reported)August 24, 2026
Actual (reported)August 27, 2026
Actual (reported)December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
incidence of positive neurophysiological stimulation,
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)
Standard Versus Anatomically Complex ("Red Screw") Trajectories for pedicle screw placement with patient specific guides (MySpine - medacta) in complex deformity cases
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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.
IRCCS Ospedale Galeazzi-Sant'Ambrogio
Milan, MI, 20132, Italy
130 participants (actual enrollment reported by the registry).
First Submitted
August 24, 2026
First Posted
August 27, 2026
Study Start
May 15, 2026
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
August 14, 2026
Actual (reported)Study Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
August 27, 2026
Record last verified: 2026-08
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Source: ClinicalTrials.gov.
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