ADDRESS - Adult Deformity Robotic vs. Freehand Surgery to Correct Spinal Deformity
Last updated on September 2021Recruitment
- 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- Withdrawn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 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).
- ...
- 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 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).
- Patient capable of complying with study requirements
- Signed informed consent by patient
Exclusion Criteria
- Patients who have participated in a research study involving an investigational product in the 12 weeks prior to surgery
- Paraplegia
- 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
- Paraplegia
- 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
- Patient cannot or will not sign informed consent
- Neurologic diseases (e.g. Charcot-Marie Tooth, Guillain-Barre syndrome, cerebral palsy, spina bifida, or neurofibroma)
- Primary abnormalities of bones (e.g. osteogenesis imperfecta)
- Spinal cord lesions requiring neurosurgical interventions, such as hydromyelia
- Spinal cord abnormalities with any neurologic symptoms or signs
- Infection or malignancy
- Pregnancy
- 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
- 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 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).
- ...
- 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 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).
- Patient capable of complying with study requirements
- Signed informed consent by patient
Exclusion Criteria
- Patients who have participated in a research study involving an investigational product in the 12 weeks prior to surgery
- Paraplegia
- 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
- Paraplegia
- 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
- Patient cannot or will not sign informed consent
- Neurologic diseases (e.g. Charcot-Marie Tooth, Guillain-Barre syndrome, cerebral palsy, spina bifida, or neurofibroma)
- Primary abnormalities of bones (e.g. osteogenesis imperfecta)
- Spinal cord lesions requiring neurosurgical interventions, such as hydromyelia
- Spinal cord abnormalities with any neurologic symptoms or signs
- Infection or malignancy
- Pregnancy
- Primary muscle diseases, such as muscular dystrophy
Locations
- Kansas City, Kansas, 66160
- Kansas City, Kansas, 66160
Tracking Information
- NCT #
- NCT02058238
- Collaborators
- Not Provided
- Investigators
- Study Director: Doron Dinstein, MD Mazor Robotics
Get Well Soon