ADDRESS - Adult Deformity Robotic vs. Freehand Surgery to Correct Spinal Deformity

Withdrawn before enrolling

Conditions studied: Scoliosis, Kyphosis, Kyphoscoliosis, Spinal Deformity, Spondylosis

In brief

To quantify potential short- and long-term benefits of robotically-guided minimally invasive (MIS) or open-approach spine surgery in adult patients undergoing multi-level spinal instrumentation surgery, in comparison to image- or navigation-guided instrumentation in a matching cohort of control patients, performed using a freehand technique, both in MIS and open approaches.

Key facts

Study ID

NCT02058238

Run by

Mazor Robotics

People needed

0

Starts

2014-10-03

Expected to finish

2015-03-01

Last updated by the study team

2020-10-05

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Infection or malignancy
• Primary abnormalities of bones (e.g. osteogenesis imperfecta)
• Primary muscle diseases, such as muscular dystrophy
• 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
• Paraplegia
• Patients who have participated in a research study involving an investigational product in the 12 weeks prior to surgery
• 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.
• Pregnancy
• Patient cannot follow study protocol, for any reason
• Patient cannot or will not sign informed consent

Where it is running

• University of Kansas Medical Center — Kansas City, Kansas, United States

Full record on ClinicalTrials.gov

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