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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Scoliosis; Spondylosis; Kyphoscoliosis; Spinal Deformity; Kyphosis

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients (age over 21 years) undergoing long (5 or more consecutive vertebrae) open or minimally invasive instrumentation, correction and fusion sugery in the thoracic, lumbar or sacral spine who have been found to have kypho/scoliotic curve, sagittal or coronal imbalance or a combination of these.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Arm 1: Robotic-guided, Open approach; 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; 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; 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; 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?

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

Collaborators and Investigators

• Sponsor: Mazor Robotics
• Investigators: Study Director: Doron Dinstein, MD, Mazor Robotics

Publications and helpful links

General Publications

• Devito DP, Kaplan L, Dietl R, Pfeiffer M, Horne D, Silberstein B, Hardenbrook M, Kiriyanthan G, Barzilay Y, Bruskin A, Sackerer D, Alexandrovsky V, Stuer C, Burger R, Maeurer J, Donald GD, Schoenmayr R, Friedlander A, Knoller N, Schmieder K, Pechlivanis I, Kim IS, Meyer B, Shoham M. Clinical acceptance and accuracy assessment of spinal implants guided with SpineAssist surgical robot: retrospective study. Spine (Phila Pa 1976). 2010 Nov 15;35(24):2109-15. doi: 10.1097/BRS.0b013e3181d323ab. Erratum In: Spine (Phila Pa 1976). 2011 Jan 1;36(1):91. Gordon, Donald G [corrected to Donald, Gordon D].
• Hu X, Ohnmeiss DD, Lieberman IH. Use of an ultrasonic osteotome device in spine surgery: experience from the first 128 patients. Eur Spine J. 2013 Dec;22(12):2845-9. doi: 10.1007/s00586-013-2780-y. Epub 2013 Apr 16.

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2014
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: February 6, 2014
• First Submitted That Met QC Criteria: February 7, 2014
• First Posted (Estimate): February 10, 2014

Study Record Updates

• Last Update Posted (Actual): October 5, 2020
• Last Update Submitted That Met QC Criteria: September 30, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Scoliosis; Spondylosis; Spinal deformity; Robotic-guided spinal fusions; Kyphoscoliosis
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Congenital Abnormalities; Scoliosis; Spondylosis; Kyphosis
• Other Study ID Numbers: CLN105