ADDRESS - Adult Deformity Robotic vs. Freehand Surgery to Correct Spinal Deformity
Last updated on April 2022Recruitment
- Recruitment Status
- Withdrawn
- Estimated Enrollment
- 2000
Inclusion Criteria
- 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.
- Patient capable of complying with study requirements
- ...
- 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.
- Patient capable of complying with study requirements
- 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.
- 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).
Exclusion Criteria
- Primary abnormalities of bones (e.g. osteogenesis imperfecta)
- Neurologic diseases (e.g. Charcot-Marie Tooth, Guillain-Barre syndrome, cerebral palsy, spina bifida, or neurofibroma)
- Spinal cord lesions requiring neurosurgical interventions, such as hydromyelia
- ...
- Primary abnormalities of bones (e.g. osteogenesis imperfecta)
- Neurologic diseases (e.g. Charcot-Marie Tooth, Guillain-Barre syndrome, cerebral palsy, spina bifida, or neurofibroma)
- Spinal cord lesions requiring neurosurgical interventions, such as hydromyelia
- Infection or malignancy
- Primary muscle diseases, such as muscular dystrophy
- Pregnancy
- Spinal cord abnormalities with any neurologic symptoms or signs
- 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.
- Patients who have participated in a research study involving an investigational product in the 12 weeks prior to surgery
- Patient cannot follow study protocol, for any reason
- Paraplegia
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
- 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.
- Patient capable of complying with study requirements
- ...
- 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.
- Patient capable of complying with study requirements
- 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.
- 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).
Exclusion Criteria
- Primary abnormalities of bones (e.g. osteogenesis imperfecta)
- Neurologic diseases (e.g. Charcot-Marie Tooth, Guillain-Barre syndrome, cerebral palsy, spina bifida, or neurofibroma)
- Spinal cord lesions requiring neurosurgical interventions, such as hydromyelia
- ...
- Primary abnormalities of bones (e.g. osteogenesis imperfecta)
- Neurologic diseases (e.g. Charcot-Marie Tooth, Guillain-Barre syndrome, cerebral palsy, spina bifida, or neurofibroma)
- Spinal cord lesions requiring neurosurgical interventions, such as hydromyelia
- Infection or malignancy
- Primary muscle diseases, such as muscular dystrophy
- Pregnancy
- Spinal cord abnormalities with any neurologic symptoms or signs
- 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.
- Patients who have participated in a research study involving an investigational product in the 12 weeks prior to surgery
- Patient cannot follow study protocol, for any reason
- Paraplegia
Tracking Information
- NCT #
- NCT02058238
- Collaborators
- Not Provided
- Investigators
- Study Director: Doron Dinstein, MD Mazor Robotics
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