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

NCT07790068 | Active Not Recruiting

• 1 other identifier: Red Screws
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

MySpine; Complex trajectory screws; Adult sagittal deformity; Idiopatic scoliosis; Congenital, syndromic and neuromuscolar spinal deformity

Outcome Measures

Primary Outcomes (1)

• 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)

Interventions

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

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

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Incomplete clinical documentation
• Procedures performed without using MySpine guides

Sponsors & Collaborators

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

Study Sites (1)

IRCCS Ospedale Galeazzi-Sant'Ambrogio

Milan, MI, 20132, Italy

Location

MeSH Terms

Conditions

Scheuermann Disease; Scoliosis

Condition Hierarchy (Ancestors)

Spinal Osteochondrosis; Osteochondrosis; Bone Diseases; Musculoskeletal Diseases; Kyphosis; Spinal Curvatures; Spinal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: August 27, 2026
• Study Start: May 15, 2026
• Primary Completion: August 14, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 27, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)