Advanced SPinal Innovations With Robotics and Enabling Technology Registry

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-21
SponsorBoston Children's Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial population

Study participants will be those receiving treatment for spinal deformity at one of the participating sites. Eligible patients will be identified from clinical databases of children undergoing surgery for spinal deformity.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

700 Participants
are grouped into 1 trial group
Group A: Pediatric Spine Deformity Patients

Trial outcomes

Primary outcomes

1

proportion of pedicle screws within 2 mm of cortical breach

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

Time frame
Time of surgery

Secondary outcomes

1

radiation dose to patient and surgeon per screw

Radiation dose to patient and surgeon per screw based on the following imaging studies when performed: preoperative CT scan, intraoperative O-arm scans, and fluoroscopy.

Time frame
Time of surgery
2

Scoliosis Research Society (SRS-30) Questionnaire

Questionnaires will be completed by both the patient and caregiver based on their appropriate diagnosis (i.e. idiopathic, congenital, spondylolisthesis, etc.).

Time frame
Baseline, 6 Months, 1 Year, 2 Years, and 5 Years
3

Early Onset Scoliosis 24-Item Questionnaire (EOSQ-24)

Questionnaires will be completed by both the patient and caregiver based on their appropriate diagnosis (i.e. idiopathic, congenital, spondylolisthesis, etc.).

Time frame
Baseline, 6 Months, 1 Year, 2 Years, and 5 Years
4

Caregiver Priorities & Child Health Index of Life with Disabilities (CP Child)

Questionnaires will be completed by both the patient and caregiver based on their appropriate diagnosis (i.e. idiopathic, congenital, spondylolisthesis, etc.).

Time frame
Baseline, 6 Months, 1 Year, 2 Years, and 5 Years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Boston Children's Hospital

Lead sponsor

Pediatric Orthopaedic Society of North America

Collaborator

Medtronic

Collaborator

Children's Hospital Colorado

Collaborator

Hospital for Special Surgery, New York

Collaborator

Children's Healthcare of Atlanta

Collaborator

Rainbow Babies and Children's Hospital

Collaborator

Dell Children's Medical Center of Central Texas

Collaborator

Medical University of South Carolina Shawn Jenkins Children's Hospital

Collaborator

St. Luke's Medical Center

Collaborator

University of Florida

Collaborator