Recruitment

Recruitment Status
Withdrawn
Estimated Enrollment
2000

Inclusion Criteria

Patient capable of complying with study requirements
Cases may include augmented cases (when one or more of the screws are inserted into vertebrae after a vertebral augmentation procedure, such as kyphoplasty or vertebroplasty).
Cases may include surgeries involving iliac screws (e.g., Galveston technique or S2AI screws) although these screws will not be included in the data analysis.
...
Patient capable of complying with study requirements
Cases may include augmented cases (when one or more of the screws are inserted into vertebrae after a vertebral augmentation procedure, such as kyphoplasty or vertebroplasty).
Cases may include surgeries involving iliac screws (e.g., Galveston technique or S2AI screws) although these screws will not be included in the data analysis.
Signed informed consent by patient
Adult patients (age 21 years and older), undergoing long (5 consecutive vertebrae or more) spinal fusion surgery, between T1 to the sacrum.

Exclusion Criteria

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

Summary

Conditions
  • Kyphoscoliosis
  • Kyphosis
  • Scoliosis
  • Spinal Deformity
  • Spondylosis
Type
Observational
Design
  • Observational Model: Case-Control
  • Time Perspective: Prospective

Participation Requirements

Age
Between 21 years and 125 years
Gender
Both males and females

Inclusion Criteria

Patient capable of complying with study requirements
Cases may include augmented cases (when one or more of the screws are inserted into vertebrae after a vertebral augmentation procedure, such as kyphoplasty or vertebroplasty).
Cases may include surgeries involving iliac screws (e.g., Galveston technique or S2AI screws) although these screws will not be included in the data analysis.
...
Patient capable of complying with study requirements
Cases may include augmented cases (when one or more of the screws are inserted into vertebrae after a vertebral augmentation procedure, such as kyphoplasty or vertebroplasty).
Cases may include surgeries involving iliac screws (e.g., Galveston technique or S2AI screws) although these screws will not be included in the data analysis.
Signed informed consent by patient
Adult patients (age 21 years and older), undergoing long (5 consecutive vertebrae or more) spinal fusion surgery, between T1 to the sacrum.

Exclusion Criteria

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

Tracking Information

NCT #
NCT02058238
Collaborators
Not Provided
Investigators
Study Director: Doron Dinstein, MD Mazor Robotics
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