Advanced Spinal Innovations With Robotics and Enabling Technology Registry

This study is creating a registry (a collection of information) about pediatric (children's) spine surgery. It's looking at how robotics, navigation (like a GPS for surgery), and patient-specific rods (custom-made implants) are used together in children and young adults up to age 21 who have spine deformities like scoliosis. The main goal is to see how often pedicle screws (implants used in spine surgery) are placed within 2 mm of the bone's edge during surgery. This is an observational study, meaning researchers are collecting information without giving specific treatments. The study is open to children and young adults aged 0 to 21 with a spine deformity who are scheduled for surgery using these technologies and can speak English or Spanish. The current status of the study is unclear.

Study design
This is an observational study with a planned enrollment of 700 participants. It is not a phase-specific trial.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, pedicle screw placement accuracy, is measured at the time of surgery. Further follow-up is not specified.

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NCT05071144

Advanced SPinal Innovations With Robotics and Enabling Technology Registry

Recruiting
Not specifiedAges 0–21Observational
Boston Children's Hospital
~700 participants
Updated 2026-06-22 on ClinicalTrials.gov

At a glance

Recruiting sites
7 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
proportion of pedicle screws within 2 mm of cortical breach
Measured over Time of surgery
Spine Deformity
Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis
Spondylolisthesis
Congenital Scoliosis
Neuromuscular Scoliosis
10 sites across 10 states
California1
Colorado1
Georgia1
Massachusetts1
Missouri1
New York1
Ohio1
Pennsylvania1
  • Daniel Hedequist, MD · PRINCIPAL_INVESTIGATOR · Boston Children's Hospital

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Eligibility criteria

Inclusion

Diagnosis of a spine deformity
Scheduled for surgery using robotics and navigation and/or patient-specific rods
Up to and including 21 years of age
Speak and read English or Spanish
  • proportion of pedicle screws within 2 mm of cortical breachTime of surgery

    The proportion of pedicle screws within 2 mm of cortical breach when assessed on intraoperative O-arm scans and postoperative CT scans (when applicable).