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Can 3D-printed guides tame the toughest spine screws?

NCT ID NCT07790068

Knowledge-focused Sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time

Summary

Researchers are reviewing past spinal fusion surgeries to see if patient-specific guides, called MySpine, place screws safely even in the most challenging bone. They will compare nerve irritation rates between standard screws and those in anatomically complex positions, known as "Red Screws." The study includes 130 patients and over 2,600 screws placed over a decade. The goal is to understand whether these custom guides can be trusted for difficult spinal deformities.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Patient-specific guides (MySpine, Medacta) for pedicle screw placement
What this could lead to
If the complex screw trajectories prove as safe as standard ones, surgeons may gain confidence using these guides in challenging spinal deformities, potentially improving outcomes.
What could go wrong
This is a retrospective review, so it can only show associations, not prove cause and effect. The results may not apply to other hospitals or guide systems.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

130 people

The number who actually took part.

Started

May 2026

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

adolescent idiopathic scoliosis idiopathic scoliosis Scheuermann disease scoliosis vertebral column disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Adult scoliosis Adult spinal deformity Scheuermann disease Scheuermann's kyphosis Scoliosis associated with other conditions Scoliosis idiopathic Scoliosis idiopathic adolescent Scoliosis idiopathic adolescent treatment

Contacts and locations

Locations

  • IRCCS Ospedale Galeazzi-Sant'Ambrogio

    Milan, MI, 20132, Italy

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