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- Withdrawn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 augmented cases (when one or more of the screws are inserted into vertebrae after a vertebral augmentation procedure, such as kyphoplasty or vertebroplasty).
- 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.
- ...
- 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).
- 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.
Exclusion Criteria
- Infection or malignancy
- Patient cannot or will not sign informed consent
- Paraplegia
- ...
- Infection or malignancy
- Patient cannot or will not sign informed consent
- Paraplegia
- Spinal cord abnormalities with any neurologic symptoms or signs
- 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.
- Primary abnormalities of bones (e.g. osteogenesis imperfecta)
- Patient cannot follow study protocol, for any reason
- 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
- Spinal cord lesions requiring neurosurgical interventions, such as hydromyelia
- 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
- 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).
- 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.
- ...
- 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).
- 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.
Exclusion Criteria
- Infection or malignancy
- Patient cannot or will not sign informed consent
- Paraplegia
- ...
- Infection or malignancy
- Patient cannot or will not sign informed consent
- Paraplegia
- Spinal cord abnormalities with any neurologic symptoms or signs
- 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.
- Primary abnormalities of bones (e.g. osteogenesis imperfecta)
- Patient cannot follow study protocol, for any reason
- 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
- Spinal cord lesions requiring neurosurgical interventions, such as hydromyelia
- Primary muscle diseases, such as muscular dystrophy
Tracking Information
- NCT #
- NCT02058238
- Collaborators
- Not Provided
- Investigators
- Study Director: Doron Dinstein, MD Mazor Robotics