ADDRESS - Adult Deformity Robotic vs. Freehand Surgery to Correct Spinal Deformity
Last updated on April 2022Recruitment
- Recruitment Status
- Withdrawn
- Estimated Enrollment
- 2000
Inclusion Criteria
- 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
- Signed informed consent by patient
- ...
- 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
- Signed informed consent by patient
- 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).
- Adult patients (age 21 years and older), undergoing long (5 consecutive vertebrae or more) spinal fusion surgery, between T1 to the sacrum.
Exclusion Criteria
- Infection or malignancy
- 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.
- Neurologic diseases (e.g. Charcot-Marie Tooth, Guillain-Barre syndrome, cerebral palsy, spina bifida, or neurofibroma)
- ...
- Infection or malignancy
- 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.
- 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
- Primary abnormalities of bones (e.g. osteogenesis imperfecta)
- Patient cannot follow study protocol, for any reason
- Primary muscle diseases, such as muscular dystrophy
- Patient cannot or will not sign informed consent
- Paraplegia
- Patients who have participated in a research study involving an investigational product in the 12 weeks prior to surgery
- Pregnancy
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
- 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
- Signed informed consent by patient
- ...
- 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
- Signed informed consent by patient
- 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).
- Adult patients (age 21 years and older), undergoing long (5 consecutive vertebrae or more) spinal fusion surgery, between T1 to the sacrum.
Exclusion Criteria
- Infection or malignancy
- 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.
- Neurologic diseases (e.g. Charcot-Marie Tooth, Guillain-Barre syndrome, cerebral palsy, spina bifida, or neurofibroma)
- ...
- Infection or malignancy
- 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.
- 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
- Primary abnormalities of bones (e.g. osteogenesis imperfecta)
- Patient cannot follow study protocol, for any reason
- Primary muscle diseases, such as muscular dystrophy
- Patient cannot or will not sign informed consent
- Paraplegia
- Patients who have participated in a research study involving an investigational product in the 12 weeks prior to surgery
- Pregnancy
Tracking Information
- NCT #
- NCT02058238
- Collaborators
- Not Provided
- Investigators
- Study Director: Doron Dinstein, MD Mazor Robotics
Get Well Soon