Advanced SPinal Innovations With Robotics and Enabling Technology Registry

Part of paid clinical trials in Los Angeles, California.

Sponsor
Boston Children's Hospital
Study ID
NCT05071144
Status
Recruiting

Conditions

  • Adolescent Idiopathic Scoliosis
  • Congenital Scoliosis
  • Idiopathic Scoliosis
  • Neuromuscular Scoliosis
  • Spine Deformity
  • Spondylolisthesis

Eligibility Criteria

Sex
ALL
Age
0 Years - 21 Years
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

Start date
Dec 13, 2021
Status verified
Mar 2026
Primary completion
Dec 31, 2030
Completion
Dec 31, 2031

Study Design

Enrollment
700 participants (estimated)

Arms

  • Arm: Pediatric Spine Deformity Patients
    Standard of care surgery using robotics coupled with navigation and/or patient-specific rods

Primary Outcome Measure

proportion of pedicle screws within 2 mm of cortical breach [ Time Frame: Time of surgery ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Medical CenterLos AngelesCalifornia90048
David Skaggs, MD
David Skaggs, MD (PRINCIPAL_INVESTIGATOR)
Children's Hospital ColoradoAuroraColorado80045
Mark Erickson, MD
Mark Erickson, MD (PRINCIPAL_INVESTIGATOR)
Children's Healthcare of AtlantaAtlantaGeorgia30342
Dennis Devito, MD
Dennis Devito, MD (PRINCIPAL_INVESTIGATOR)
Boston Children's HospitalBostonMassachusetts02115
Sara Olenich, MS, CSCS
857-218-3272
Danielle DiPersio
617-919-1632
Daniel Hedequist, MD (PRINCIPAL_INVESTIGATOR)
St. Louis Children's HospitalSt LouisMissouri63110
Blake Montgomery, MD
Blake Montgomery, MD (PRINCIPAL_INVESTIGATOR)
Hospital for Special SurgeryNew YorkNew York10021
Roger Widmann, MD
Roger Widmann, MD (PRINCIPAL_INVESTIGATOR)
Jessica Heyer, MD (SUB_INVESTIGATOR)
Rainbow Babies & Children's HospitalClevelandOhio44106
Michael Glotzbecker, MD
Michael Glotzbecker, MD (PRINCIPAL_INVESTIGATOR)
St. Luke's University Health NetworkBethlehemPennsylvania18015
Dustin Greenhill, MD
484-526-1735
Dustin Greenhill, MD (PRINCIPAL_INVESTIGATOR)
Medical University of South Carolina Shawn Jenkins Children's HospitalCharlestonSouth Carolina29425
Robert Murphy, MD
Robert Murphy, MD (PRINCIPAL_INVESTIGATOR)
Dell Children's Medical CenterAustinTexas78723
Kirsten Ross, MD
Brian Kaufman, MD (PRINCIPAL_INVESTIGATOR)
Kirsten Ross, MD (PRINCIPAL_INVESTIGATOR)

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