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Recruiting NCT05071144

Advanced SPinal Innovations With Robotics and Enabling Technology Registry

— Observational Spine Deformity Idiopathic Scoliosis Adolescent Idiopathic Scoliosis Spondylolisthesis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Spine Deformity, Idiopathic Scoliosis, Adolescent Idiopathic Scoliosis, Spondylolisthesis. Basic parameters: 0 years — 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

Creation of a pediatric robotic spine surgery registry will allow for data collection and analysis on the coupled use of robotics and navigation, as well as patient-specific rods in pediatric spine deformity surgery across participating study institutions. Eventually, an educational and informative framework for this technology will be established.

Primary outcome measures

  • proportion of pedicle screws within 2 mm of cortical breach [Time frame: Time of surgery]
Secondary outcome measures (12)
  • radiation dose to patient and surgeon per screw [Time frame: Time of surgery]
  • Scoliosis Research Society (SRS-30) Questionnaire [Time frame: Baseline, 6 Months, 1 Year, 2 Years, and 5 Years]
  • Early Onset Scoliosis 24-Item Questionnaire (EOSQ-24) [Time frame: Baseline, 6 Months, 1 Year, 2 Years, and 5 Years]
  • Caregiver Priorities & Child Health Index of Life with Disabilities (CP Child) [Time frame: Baseline, 6 Months, 1 Year, 2 Years, and 5 Years]
  • Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Activity [Time frame: Baseline, 6 Months, 1 Year, 2 Years, and 5 Years]
  • Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress - Anxiety [Time frame: Baseline, 6 Months, 1 Year, 2 Years, and 5 Years]
  • Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress - Depressive Symptoms [Time frame: Baseline, 6 Months, 1 Year, 2 Years, and 5 Years]
  • Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function - Mobility [Time frame: Baseline, 6 Months, 1 Year, 2 Years, and 5 Years]
  • Patient-Reported Outcomes Measurement Information System (PROMIS) Pain - Interference [Time frame: Baseline, 6 Months, 1 Year, 2 Years, and 5 Years]
  • Patient-Reported Outcomes Measurement Information System (PROMIS) Peer Relationships [Time frame: Baseline, 6 Months, 1 Year, 2 Years, and 5 Years]
  • Operative time [Time frame: Time of surgery]
  • Estimated blood loss (EBL) [Time frame: Time of surgery]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • None

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 10 centers
  • Cedars-Sinai Medical Center — Los Angeles
  • Children's Hospital Colorado — Aurora
  • Children's Healthcare of Atlanta — Atlanta
  • Boston Children's Hospital — Boston
  • St. Louis Children's Hospital — St Louis
  • Hospital for Special Surgery — New York
  • Rainbow Babies & Children's Hospital — Cleveland
  • St. Luke's University Health Network — Bethlehem
  • … and 2 more centers

Identifiers

NCT: NCT05071144 · IRB-P00039760

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗