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

Study Overview
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Brief Summary
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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.

Official Title
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ADDRESS - Multicenter, Partially-randomized Controlled Trial of Adult Deformity Robotic vs. Freehand Surgery to Correct Adult Spine Deformity

Conditions
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Scoliosis, Kyphosis, Kyphoscoliosis, Spinal Deformity, Spondylosis

Participation Criteria
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Eligibility Criteria
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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). Patient capable of complying with study requirements Signed informed consent by patient Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Arm 1: Robotic-guided, Open approach<br>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<br>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<br>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<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of surgical complications | New neural deficits, implant-related durotomy, infection requiring surgery, excessive blood loss | 1 year | 
| Intraoperative radiation exposure | as measured by the C-arm, normalized per screw | Day of operation | 
| Revision surgeries | All cause revisions, including medical and surgical complications. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Deformity correction as measured on plain radiographs | Parameters of sagittal and coronal balance | Within 2 years from surgery | 
| Clinical outcome measures assessed using health-related quality of life questionnaires | Visual Analog Scale (VAS) back and leg, Oswestry Disability Index (ODI), SRS22 questionnaire, European Quality - 5 dimensions (EQ-5D-5L) | up to 10 years post-operative | 
| Pedicle screw instrumentation accuracy | Accuracy will be quantified in millimeters and scored using the Gertzbein Robbins classification, based on post-operative CTs that are clinically necessary for the management of the patient. | Within 1 year of surgery | 
| Length of convalescence | Length of stay at the hospital, destination at discharge, time to return to normal activities, time to return to work | Within 2 years of surgery | 
| Ratio of executed vs. planned screws | Number of screws planned to be robotically inserted but manually inserted instead, and cause. | Day of surgery | 
| Times of intra-operative stages | Instrumentation time per screw, total surgery time | Day of surgery | 
| Implant Failure | The implant failure rate as measured within one year post-surgery | Within 1 year post-surgery | 
| Number of Abandoned Screws | Number of screws intended to be instrumented with the robot and abandoned for cause. | Day of surgery | 
| Number of screws instrumented freehand | Number of screws planned to be instrumented robotically and instrumented freehand instead. | Day of surgery | 
| Clinical performance of instrumentation technique | Implant instrumentation time, length of surgery | Day of surgery | 
| Fusion rate/pseudoarthrosis | Fusion/pseudoarthrosis as measured within one year of surgery | Within one year post-surgery | 
| Neuromonitoring events | The number of clinically significant neuromonitoring events that may or may not lead to removal or reinstrumentation of the pedicle screw. | Day of surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Robotic-guided spinal fusions, Scoliosis, Kyphoscoliosis, Spinal deformity, Spondylosis