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

• ClinicalTrials.gov Identifier: NCT02058238
• Recruitment Status: Withdrawn
• First Posted: February 10, 2014
• Last Update Posted: October 5, 2020
• Sponsor: Mazor Robotics
• Information provided by (Responsible Party): Mazor Robotics

Study Description

Brief Summary:

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.

Condition or disease
Scoliosis; Kyphosis; Kyphoscoliosis; Spinal Deformity; Spondylosis

Study Design

• Study Type: Observational
• Actual Enrollment: 0 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: ADDRESS - Multicenter, Partially-randomized Controlled Trial of Adult Deformity Robotic vs. Freehand Surgery to Correct Adult Spine Deformity
• Actual Study Start Date: October 3, 2014
• Actual Primary Completion Date: March 1, 2015
• Actual Study Completion Date: March 1, 2015

Groups and Cohorts

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.

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 21 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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.

Criteria

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

Contacts and Locations

Locations

United States, Kansas

University of Kansas Medical Center

Kansas City, Kansas, United States, 66160

Sponsors and Collaborators

Mazor Robotics

Investigators

• Study Director: Doron Dinstein, MD; Mazor Robotics

More Information

Publications:

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.

Devito DP, Kaplan L, Dietl R, Pfeiffer M, Horne D, Silberstein B, Hardenbrook M, Kiriyanthan G, Barzilay Y, Bruskin A, Sackerer D, Alexandrovsky V, Stüer 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].

• Responsible Party: Mazor Robotics
• ClinicalTrials.gov Identifier: NCT02058238
• Other Study ID Numbers: CLN105
• First Posted: February 10, 2014
• Last Update Posted: October 5, 2020
• Last Verified: September 2020

Keywords provided by Mazor Robotics:

Robotic-guided spinal fusions; Scoliosis; Kyphoscoliosis; Spinal deformity; Spondylosis

Additional relevant MeSH terms:

Scoliosis; Spondylosis; Kyphosis; Congenital Abnormalities; Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases