Recruitment

Recruitment Status
Withdrawn
Estimated Enrollment
2000

Inclusion Criteria

Adult patients (age 21 years and older), undergoing long (5 consecutive vertebrae or more) spinal fusion surgery, between T1 to the sacrum.
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.
...
Adult patients (age 21 years and older), undergoing long (5 consecutive vertebrae or more) spinal fusion surgery, between T1 to the sacrum.
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
Patient capable of complying with study requirements

Exclusion Criteria

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

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

Adult patients (age 21 years and older), undergoing long (5 consecutive vertebrae or more) spinal fusion surgery, between T1 to the sacrum.
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.
...
Adult patients (age 21 years and older), undergoing long (5 consecutive vertebrae or more) spinal fusion surgery, between T1 to the sacrum.
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
Patient capable of complying with study requirements

Exclusion Criteria

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

Tracking Information

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