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

Mazor Robotics

Status: Withdrawn

Conditions: Scoliosis; Spinal Deformity; Spondylosis; Kyphoscoliosis; Kyphosis

Study type: Observational

Funder types: Industry

Identifiers

NCT02058238

CLN105

Details and patient eligibility

About

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.

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adult patients (age 21 years and older), undergoing long (5 consecutive vertebrae or more) spinal fusion surgery, between T1 to the sacrum.
2. 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.
3. 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).
4. Patient capable of complying with study requirements
5. Signed informed consent by patient

Exclusion criteria

1. Infection or malignancy
2. Primary abnormalities of bones (e.g. osteogenesis imperfecta)
3. Primary muscle diseases, such as muscular dystrophy
4. Neurologic diseases (e.g. Charcot-Marie Tooth, Guillain-Barre syndrome, cerebral palsy, spina bifida, or neurofibroma)
5. Spinal cord abnormalities with any neurologic symptoms or signs
6. Spinal cord lesions requiring neurosurgical interventions, such as hydromyelia
7. Paraplegia
8. Patients who have participated in a research study involving an investigational product in the 12 weeks prior to surgery
9. 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.
10. Pregnancy
11. Patient cannot follow study protocol, for any reason
12. Patient cannot or will not sign informed consent

Trial design

0 participants in 4 patient groups

Arm 1: Robotic-guided, Open approach

Description:

Adult patients (age\> 21 years) undergoing long (\>4 consecutive vertebrae) open instrumentation, correction and fusion surgery in the thoracic, lumbar or sacral spine for a kypho/scoliotic curve, sagittal or coronal imbalance or a combination of these.

Arm 2: control-arm - non-robotic, open approach

Description:

Adult patients (age\> 21 years) undergoing long (\>4 consecutive vertebrae) open instrumentation, correction and fusion surgery in the thoracic, lumbar or sacral spine for a kypho/scoliotic curve, sagittal or coronal imbalance or a combination of these.

Arm 3: robotic-guided, MIS approach

Description:

Adult patients (age\> 21 years) undergoing long (\>4 consecutive vertebrae) open instrumentation, correction and fusion surgery in the thoracic, lumbar or sacral spine for a kypho/scoliotic curve, sagittal or coronal imbalance or a combination of these.

Arm 4: control-arm - freehand, MIS approach

Description:

Adult patients (age\> 21 years) undergoing long (\>4 consecutive vertebrae) open instrumentation, correction and fusion surgery in the thoracic, lumbar or sacral spine for a kypho/scoliotic curve, sagittal or coronal imbalance or a combination of these.