Clinical trial NCT02058238: ADDRESS - Adult Deformity Robotic vs. Freehand Surgery to Correct Spinal Deformity
Official title: ADDRESS - Multicenter, Partially-randomized Controlled Trial of Adult Deformity Robotic vs. Freehand Surgery to Correct Adult Spine Deformity
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Scoliosis
Kyphosis
Kyphoscoliosis
Spinal Deformity
Spondylosis
Keywords: Robotic-guided spinal fusions
Scoliosis
Kyphoscoliosis
Spinal deformity
Spondylosis
Lead sponsor: Mazor Robotics
Sponsor class: INDUSTRY
First posted: 2014-02-10
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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

Primary outcomes:
measure: Incidence of surgical complications
timeFrame: 1 year
measure: Intraoperative radiation exposure
timeFrame: Day of operation
measure: Revision surgeries
timeFrame: 2 years
Secondary outcomes:
measure: Deformity correction as measured on plain radiographs
timeFrame: Within 2 years from surgery
measure: Clinical outcome measures assessed using health-related quality of life questionnaires
timeFrame: up to 10 years post-operative
measure: Pedicle screw instrumentation accuracy
timeFrame: Within 1 year of surgery
measure: Length of convalescence
timeFrame: Within 2 years of surgery
measure: Ratio of executed vs. planned screws
timeFrame: Day of surgery
measure: Times of intra-operative stages
timeFrame: Day of surgery
measure: Implant Failure
timeFrame: Within 1 year post-surgery
measure: Number of Abandoned Screws
timeFrame: Day of surgery
measure: Number of screws instrumented freehand
timeFrame: Day of surgery
measure: Clinical performance of instrumentation technique
timeFrame: Day of surgery
measure: Fusion rate/pseudoarthrosis
timeFrame: Within one year post-surgery
measure: Neuromonitoring events
timeFrame: Day of surgery
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: Mazor Robotics
name: Doron Dinstein, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.