Robotic vs. Freehand Corrective Surgery for Pediatric Scoliosis



Status:Recruiting
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:10 - 21
Updated:8/19/2018
Start Date:October 2014
End Date:October 2024
Contact:Doron Dinstein, MD
Email:clinicalstudy@mazorrobotics.com
Phone:800-80-MAZOR

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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


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
We found this trial at
4
sites
Orlando, Florida 32803
Principal Investigator: Raymund Woo, MD
Phone: 407-303-5681
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3020 Childrens way
San Diego, California 92123
(858) 576-1700
Principal Investigator: Peter Newton, MD
Phone: 858-576-1700
Rady Children's Hospital - San Diego Rady Children's Hospital-San Diego is the region’s pediatric medical...
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Atlanta, Georgia 30342
Principal Investigator: Dennis P Devito, MD
Phone: 404-255-1933
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Atlanta, GA
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Danville, Pennsylvania 17822
Principal Investigator: Meagan M Fernandez, MD
Phone: 570-271-5555
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Danville, PA
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