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Recruiting

NCT Number: NCT05071144

Advanced SPinal Innovations With Robotics and Enabling Technology Registry

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.

Recruiting

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Key information

Age range

0 year–21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cedars-Sinai Medical Center, Los Angeles, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. proportion of pedicle screws within 2 mm of cortical breach

    Time frame: Time 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).

Secondary outcomes

  1. radiation dose to patient and surgeon per screw

    Time frame: Time of surgery

    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.

  2. Scoliosis Research Society (SRS-30) Questionnaire

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

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

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

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

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

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

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

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

  5. Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Activity

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

    "Self-reported capability rather than actual performance of physical activities. This includes the functioning of one's upper extremities (dexterity), lower extremities (walking or mobility), and central regions (neck, back), as well as instrumental activities of daily living."

  6. Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress - Anxiety

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

    "Fear (fearfulness, panic), anxious misery (worry, dread), hyperarousal (tension, nervousness, restlessness), and somatic symptoms related to arousal (racing heart, dizziness)."

  7. Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress - Depressive Symptoms

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

    "Negative mood (sadness, guilt), views of self (self- criticism, worthlessness), and social cognition (loneliness, interpersonal alienation), as well as decreased positive affect and engagement (loss of interest, meaning, and purpose)."

  8. Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function - Mobility

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

    "Activities of physical mobility such as getting out of bed or a chair to activities such as running."

  9. Patient-Reported Outcomes Measurement Information System (PROMIS) Pain - Interference

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

    "Consequences of pain on relevant aspects of one's life. This includes the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities."

  10. Patient-Reported Outcomes Measurement Information System (PROMIS) Peer Relationships

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

    "Quality of relationships with friends and other acquaintances."

  11. Operative time

    Time frame: Time of surgery

    Data collection on time related to robotics-navigation, including registration, screw planning, screw placement, and total time related to platform use defined as the beginning of registration to last screw placement.

  12. Estimated blood loss (EBL)

    Time frame: Time of surgery

    EBL during surgery will be reported by the surgeon or extracted from surgical documentation.

  13. Total operative cost

    Time frame: Time of surgery

    Capital expenses associated with the equipment and software, preoperative planning time, surgical time, and costs for revision surgery caused by screw malposition.

  14. Improvement to spinopelvic alignment with PSR

    Time frame: Baseline, Predicted plan, 6 months, 1 year, 2 years, 5 years

    Spinopelvic alignment parameters including pelvic tilt, pelvic incidence, lumbar lordosis, thoracic kyphosis and sagittal vertical axis

Study contacts

Contact information is provided by the study sponsor or research team.

Jessie Tonole, BA

CONTACT

[email protected]

857-218-3272

Sara Olenich, MS, CSCS

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Collaborators

  • Children's Healthcare of Atlanta
  • Children's Hospital Colorado
  • Dell Children's Medical Center of Central Texas
  • Hospital for Special Surgery, New York
  • Medical University of South Carolina Shawn Jenkins Children's Hospital
  • Medtronic
  • Pediatric Orthopaedic Society of North America
  • Rainbow Babies and Children's Hospital
  • St. Luke's Medical Center
  • University of Florida

Registry information

Acronym: ASPIRE

Important dates

Study start
2021
Primary completion
2030
Study completion
2031
First posted
Oct 8, 2021
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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