Scoliosis IdiopathicRed ScrewsNCT07790068
Evaluation of Safety of Complex Pedicle Screw Trajectories Using Patient-Specific Guides (MySpine, Medacta)
An observational study of Scoliosis Idiopathic and Scoliosis Idiopathic Adolescent, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Scoliosis Idiopathic, Scoliosis Idiopathic Adolescent, Scoliosis Associated With Other Conditions
- What is being tested?
- Patient-Specific Guides to pedicle screws placement (MySpine, Medacta)
- Type of treatment
- Medical device
- How many people
- 130 participants
- Where
- 1 siteItaly
- Study dates
- 15 May 2026to 31 Dec 2026
- How long will I take part?
- 7 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Incomplete clinical documentation
- Procedures performed without using MySpine guides
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Scoliosis Idiopathic, Scoliosis Idiopathic Adolescent, Scoliosis Associated With Other Conditions, Scoliosis Idiopathic Adolescent Treatment, Scheuermann Disease, Scheuermann's Kyphosis
- Being tested
- Patient-Specific Guides to pedicle screws placement (MySpine, Medacta)
- Keywords
- MySpine, Complex trajectory screws, Adult sagittal deformity, Idiopatic scoliosis, Congenital, syndromic and neuromuscolar spinal deformity
- Medical subject headings
- Scheuermann Disease, Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: Along the surgery time (especially during pedicle screw placement)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start15 May 2026
- Primary completion14 Aug 2026
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scoliosis IdiopathicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 130 participants (actual)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07790068
- Sponsor's protocol ID
- Red Screws
- Acronym
- Red Screws
- Status last verified
- Aug 2026
- First submitted
- 24 Aug 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Assessment of the Safety and Accuracy of Pedicle Screw Placement Using Patient-Specific Guides (MySpine, Medacta): Standard Versus Anatomically Complex ("Red Screw") Trajectories
- ClinicalTrials.gov ID
- NCT07790068
- Acronym / sponsor ID
- Red Screws / Red Screws
- Conditions
- Scoliosis Idiopathic, Scoliosis Idiopathic Adolescent, Scoliosis Associated With Other Conditions, Scoliosis Idiopathic Adolescent Treatment, Scheuermann Disease, Scheuermann's Kyphosis
- Keywords
- MySpine, Complex trajectory screws, Adult sagittal deformity, Idiopatic scoliosis, Congenital, syndromic and neuromuscolar spinal deformity
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 130 participants (actual)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 15 May 2026 (actual)
- Primary completion
- 14 Aug 2026 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 7 Days
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- Incomplete clinical documentation
- Procedures performed without using MySpine guides
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Device | – |
Primary outcome
incidence of positive neurophysiological stimulation,
Time frame: Along the surgery time (especially during pedicle screw placement)
compare the incidence of positive neurophysiological stimulation, defined as a stimulation threshold below 8 mA, between standard-trajectory screws and "Red Screws."
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Scoliosis Idiopathic and Scoliosis Idiopathic Adolescent, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of positive neurophysiological stimulation, (time frame: Along the surgery time (especially during pedicle screw placement)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.