Clinical trial NCT05071144: Spine Procedures Assisted with RoboTics and Navigation
Official title: Spine Procedures Assisted with RoboTics and Navigation Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Spine Deformity
Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis
Spondylolisthesis
Congenital Scoliosis
Neuromuscular Scoliosis
Keywords: Pediatric
Spine
Surgery
Registry
Robotic
Navigation
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: Pediatric Orthopaedic Society of North America
name: Medtronic
name: Children's Hospital Colorado
name: Hospital for Special Surgery, New York
name: Children's Healthcare of Atlanta
name: Rainbow Babies and Children's Hospital
name: Dell Children's Medical Center of Central Texas
name: Cedars-Sinai Medical Center
name: Medical University of South Carolina Shawn Jenkins Children's Hospital
name: St. Louis Children's Hospital
First posted: 2021-10-08
Enrollment: 600
Sex: ALL
Minimum age (years): 0
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

Brief summary: 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: 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

Primary outcomes:
measure: proportion of pedicle screws within 2 mm of cortical breach
timeFrame: Time of surgery
Secondary outcomes:
measure: radiation dose to patient and surgeon per screw
timeFrame: Time of surgery
measure: Scoliosis Research Society (SRS-30) Questionnaire
timeFrame: Baseline, 6 Months, 1 Year, 2 Years, and 5 Years
measure: Early Onset Scoliosis 24-Item Questionnaire (EOSQ-24)
timeFrame: Baseline, 6 Months, 1 Year, 2 Years, and 5 Years
measure: Caregiver Priorities & Child Health Index of Life with Disabilities (CP Child)
timeFrame: Baseline, 6 Months, 1 Year, 2 Years, and 5 Years
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Activity
timeFrame: Baseline, 6 Months, 1 Year, 2 Years, and 5 Years
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress - Anxiety
timeFrame: Baseline, 6 Months, 1 Year, 2 Years, and 5 Years
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress - Depressive Symptoms
timeFrame: Baseline, 6 Months, 1 Year, 2 Years, and 5 Years
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function - Mobility
timeFrame: Baseline, 6 Months, 1 Year, 2 Years, and 5 Years
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Pain - Interference
timeFrame: Baseline, 6 Months, 1 Year, 2 Years, and 5 Years
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Peer Relationships
timeFrame: Baseline, 6 Months, 1 Year, 2 Years, and 5 Years
measure: Operative time
timeFrame: Time of surgery
measure: Estimated blood loss (EBL)
timeFrame: Time of surgery
measure: Total operative cost
timeFrame: Time of surgery
measure: Improvement to spinopelvic alignment with PSR
timeFrame: Baseline, Predicted plan, 6 months, 1 year, 2 years, 5 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Saint Louis
country: United States
facility: St. Louis Children's Hospital
state: Missouri
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: Cleveland
country: United States
facility: Rainbow Babies & Children's Hospital
state: Ohio
city: Charleston
country: United States
facility: Medical University of South Carolina Shawn Jenkins Children's Hospital
state: South Carolina
city: Austin
country: United States
facility: Dell Children's Medical Center
state: Texas
Study officials:
affiliation: Boston Children's Hospital
name: Daniel Hedequist, MD
role: PRINCIPAL_INVESTIGATOR
References: