Robotic vs. Freehand Corrective Surgery for Pediatric Scoliosis (PEDSCOLI)

Multicenter, Prospective, Partially Randomized, Controlled Trial of Robotic-guided vs. Freehand Corrective Surgery for Pediatric Scoliosis

To compare the accuracy and feasibility, curvature correction and clinical outcomes of pedicle screw instrumentation with versus without robotic guidance, in pediatric and adolescent scoliosis patients

Study Overview

• Status: Terminated
• Conditions: Scoliosis

• Study Type: Observational
• Enrollment (Actual): 272

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92123
      • Rady Children's Hospital- San Diego
  • Florida
    • Orlando, Florida, United States, 32801
      • Florida Hospital for Children
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Children's Healtchare of Atlanta at Scottish Rite
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822
      • Geisinger Orthopaedic Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 21 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Pediatric/adolescent patients (age 21 years and younger) undergoing a primary surgery for the correction of a scoliotic curve of 40 degrees or greater

Description

Inclusion Criteria:

1. Pediatric/adolescent patients (age 10 to 21 years), undergoing a primary surgery for the correction of a scoliotic curve of 40 degrees or greater
2. Patient capable of complying with study requirements
3. Signed informed consent by patient

Exclusion Criteria:

1. Scheuermann's disease
2. Infection or malignancy
3. Primary abnormalities of bones (e.g. osteogenesis imperfecta)
4. Primary muscle diseases, such as muscular dystrophy
5. Neurologic diseases (e.g. Charcot-Marie Tooth, Guillain-Barre syndrome, cerebral palsy, spina bifida, or neurofibroma)
6. Spinal cord abnormalities with any neurologic symptoms or signs
7. Spinal cord lesions requiring neurosurgical interventions, such as hydromyelia
8. Patients who have participated in a research study involving an investigational product in the 12 weeks prior to surgery
9. Patients requiring anterior release or instrumentation
10. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study.
11. Pregnancy
12. Patient cannot follow study protocol, for any reason
13. Patient cannot or will not sign informed consent

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Arm 1: Robotic-guided, open approach; Robotic-guided, open approach
Arm 2: control arm- non-robotic, open approach; control arm- non-robotic, open approach°

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Revision surgeries	All cause revisions, including medical and surgical complications.	1 year post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neuromonitoring events		Day of surgery
Clinical performance of instrumentation technique	instrumentation time per screw, total surgery time, excluding: exposure and closure time, Surgeon-specific surgical techniques that impact surgery time	Day of surgery
Hypoplastic pedicles	<4 mm in diameter	Day of surgery
Improvement of radiographic and health-related quality of life metrics	post-operative radiographs and SRS22 questionnaire	up to 10 years post-operative
Length of convalescence	Length of hospital stay, destination at discharge, time to return to normal activities	within 2 years of surgery
Clinical Outcomes as measured on plain radiographs	Curvature correction and shoulder balance	2 years
Radiation Exposure	Reading of exposure in seconds (and KvP, if available) from C-arm or other imaging system used in the operating room.	Day of surgery
Ratio of executed vs. planned screws	Number of screws planned to be robotically inserted and manually inserted instead, and cause.	Day of surgery
Pedicle screw instrumentation accuracy	Accuracy will be quantified in millimeters and scored using the Gertzbein-Robbins classification, based on post-operative CTs that are clinically necessary for the management of the patient.	Within 1 year of surgery, if indicated by surgeon and clinically necessary
Surgical complications	Implant-related durotomy, infection requiring surgery, excessive blood loss, air emboli, new neural deficits, implant failure	Within first year from day of surgery

Collaborators and Investigators

• Sponsor: Mazor Robotics
• Investigators: Study Director: Doron Dinstein, MD, Mazor Robotics

Publications and helpful links

General Publications

• Devito DP, Kaplan L, Dietl R, Pfeiffer M, Horne D, Silberstein B, Hardenbrook M, Kiriyanthan G, Barzilay Y, Bruskin A, Sackerer D, Alexandrovsky V, Stuer C, Burger R, Maeurer J, Donald GD, Schoenmayr R, Friedlander A, Knoller N, Schmieder K, Pechlivanis I, Kim IS, Meyer B, Shoham M. Clinical acceptance and accuracy assessment of spinal implants guided with SpineAssist surgical robot: retrospective study. Spine (Phila Pa 1976). 2010 Nov 15;35(24):2109-15. doi: 10.1097/BRS.0b013e3181d323ab. Erratum In: Spine (Phila Pa 1976). 2011 Jan 1;36(1):91. Gordon, Donald G [corrected to Donald, Gordon D].

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): July 8, 2019
• Study Completion (Actual): July 8, 2019

Study Registration Dates

• First Submitted: March 9, 2014
• First Submitted That Met QC Criteria: March 9, 2014
• First Posted (Estimate): March 11, 2014

Study Record Updates

• Last Update Posted (Actual): August 14, 2019
• Last Update Submitted That Met QC Criteria: August 12, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Adolescent Idiopathic Scoliosis; Pediatric Scoliosis
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Scoliosis
• Other Study ID Numbers: CLN108