Evaluation of Safety of Complex Pedicle Screw Trajectories Using Patient-Specific Guides (MySpine, Medacta) (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
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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MI
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Milan, MI, Italien, 20132
- IRCCS Ospedale Galeazzi-Sant'Ambrogio
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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incidence of positive neurophysiological stimulation,
Tidsramme: Along the surgery time (especially during pedicle screw placement)
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compare the incidence of positive neurophysiological stimulation, defined as a stimulation threshold below 8 mA, between standard-trajectory screws and "Red Screws."
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Along the surgery time (especially during pedicle screw placement)
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Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Red Screws
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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