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

NCT07790068 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 130

Last updated 2026-08-27

No results posted yet for this study

Summary

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.

Conditions

  • Scoliosis Idiopathic
  • Scoliosis Idiopathic Adolescent
  • Scoliosis Associated With Other Conditions
  • Scoliosis Idiopathic Adolescent Treatment
  • Scheuermann Disease
  • Scheuermann's Kyphosis
  • Adult Scoliosis
  • Adult Spinal Deformity

Interventions

DEVICE

Patient-Specific Guides to pedicle screws placement (MySpine, Medacta)

Standard Versus Anatomically Complex ("Red Screw") Trajectories for pedicle screw placement with patient specific guides (MySpine - medacta) in complex deformity cases

Sponsors & Collaborators

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

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-15
Primary Completion
2026-08-14
Completion
2026-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07790068 on ClinicalTrials.gov