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

Mazor Robotics

Status: Terminated

Conditions: Scoliosis

Study type: Observational

Funder types: Industry

Identifiers

NCT02084264

CLN108

Details and patient eligibility

About

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

Enrollment: 272 patients

Sex: All

Ages: 10 to 21 years old

Volunteers: No Healthy Volunteers

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

Trial design

272 participants in 2 patient groups

Arm 1: Robotic-guided, open approach

Description:

Robotic-guided, open approach

Arm 2: control arm- non-robotic, open approach

Description:

control arm- non-robotic, open approach°