Robotic vs. Freehand Corrective Surgery for Pediatric Scoliosis

Stopped early

Conditions studied: Scoliosis

In brief

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

Key facts

Study ID

NCT02084264

Run by

Mazor Robotics

People needed

272

Starts

2014-10-01

Expected to finish

2019-07-08

Last updated by the study team

2019-08-14

Who can join

Age: 10 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• Scheuermann's disease
• Infection or malignancy
• Primary abnormalities of bones (e.g. osteogenesis imperfecta)
• Primary muscle diseases, such as muscular dystrophy
• Neurologic diseases (e.g. Charcot-Marie Tooth, Guillain-Barre syndrome, cerebral palsy, spina bifida, or neurofibroma)
• Spinal cord abnormalities with any neurologic symptoms or signs
• Spinal cord lesions requiring neurosurgical interventions, such as hydromyelia
• Patients who have participated in a research study involving an investigational product in the 12 weeks prior to surgery
• Patients requiring anterior release or instrumentation
• 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.
• Pregnancy
• Patient cannot follow study protocol, for any reason
• Patient cannot or will not sign informed consent

Where it is running

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

Full record on ClinicalTrials.gov

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