Trial record 7 of 16 for:    Open Studies | "Kyphosis"

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2014 by Mazor Robotics
Sponsor:
Information provided by (Responsible Party):
Mazor Robotics
ClinicalTrials.gov Identifier:
NCT02058238
First received: February 6, 2014
Last updated: August 25, 2014
Last verified: August 2014
  Purpose

The goal of ADDRESS is to quantify potential short- and long-term benefits of robotically-guided minimally invasive (MIS) or open spine surgery in adult spinal deformity patients, 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
Scoliosis
Kyphosis
Kyphoscoliosis
Spinal Deformity
Spondylosis

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Mazor Robotics:

Primary Outcome Measures:
  • Incidence of surgical complications [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    New neural deficits, implant-related durotomy, infection requiring surgery, excessive blood loss

  • Intraoperative radiation exposure [ Time Frame: Day of operation ] [ Designated as safety issue: No ]
    as measured by the C-arm, normalized per screw

  • Revision surgeries [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    All cause revisions, including medical and surgical complications.


Secondary Outcome Measures:
  • Deformity correction as measured on plain radiographs [ Time Frame: Within 2 years from surgery ] [ Designated as safety issue: No ]
    Parameters of sagittal and coronal balance

  • Clinical outcome measures assessed using health-related quality of life questionnaires [ Time Frame: up to 10 years post-operative ] [ Designated as safety issue: No ]
    Visual Analog Scale (VAS) back and leg, Oswestry Disability Index (ODI), SRS22 questionnaire, European Quality - 5 dimensions (EQ-5D-5L)

  • Pedicle screw instrumentation accuracy [ Time Frame: Within 1 year of surgery ] [ Designated as safety issue: No ]
    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.

  • Length of convalescence [ Time Frame: Within 2 years of surgery ] [ Designated as safety issue: No ]
    Length of stay at the hospital, destination at discharge, time to return to normal activities, time to return to work

  • Ratio of executed vs. planned screws [ Time Frame: Day of surgery ] [ Designated as safety issue: No ]
    Number of screws planned to be robotically inserted but manually inserted instead, and cause.

  • Times of intra-operative stages [ Time Frame: Day of surgery ] [ Designated as safety issue: No ]
    Instrumentation time per screw, total surgery time

  • Implant Failure [ Time Frame: Within 1 year post-surgery ] [ Designated as safety issue: No ]
    The implant failure rate as measured within one year post-surgery

  • Number of Abandoned Screws [ Time Frame: Day of surgery ] [ Designated as safety issue: No ]
    Number of screws intended to be instrumented with the robot and abandoned for cause.

  • Number of screws instrumented freehand [ Time Frame: Day of surgery ] [ Designated as safety issue: No ]
    Number of screws planned to be instrumented robotically and instrumented freehand instead.

  • Clinical performance of instrumentation technique [ Time Frame: Day of surgery ] [ Designated as safety issue: No ]
    Implant instrumentation time, length of surgery

  • Fusion rate/pseudoarthrosis [ Time Frame: Within one year post-surgery ] [ Designated as safety issue: No ]
    Fusion/pseudoarthrosis as measured within one year of surgery

  • Neuromonitoring events [ Time Frame: Day of surgery ] [ Designated as safety issue: No ]
    The number of clinically significant neuromonitoring events that may or may not lead to removal or reinstrumentation of the pedicle screw.


Estimated Enrollment: 2000
Study Start Date: August 2014
Estimated Study Completion Date: January 2027
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
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 as a primary procedure for a significant 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 as a primary procedure for a significant kypho/scoliotic curve, sagittal or coronal imbalance or a combination of these.
Arm 3: robotic-guided, MIS appraoch
Adult patients (age> 21 years) undergoing long (>4 consecutive vertebrae) open instrumentation, correction and fusion surgery in the thoracic, lumbar or sacral spine as a primary procedure for a significant 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 as a primary procedure for a significant kypho/scoliotic curve, sagittal or coronal imbalance or a combination of these.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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 as a primary procedure for a significant kypho/scoliotic curve, sagittal or coronal imbalance or a combination of these.

Criteria

Inclusion Criteria:

  1. Adult patients (age over 21 years), undergoing long (5 or more consecutive vertebrae) spinal fusion surgery, between T1 to the sacrum, as a primary correction surgery of a significant kypho/scoliotic curve, and/or sagittal and/or coronal imbalance.
  2. Including surgeries involving iliac screws (e.g., Galveston technique or S2-Ala-Iliac screws) although these screws will not be included in the data analysis.
  3. Including 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02058238

Contacts
Contact: Doron Dinstein, MD 800-80-MAZOR linicalstudy@mazorrobotics.com

Locations
United States, California
University of California, Irvine Medical Center Not yet recruiting
Irvine, California, United States, 92697
Contact: Deeba Pourmand, MS    714-456-7012    dpourman@uci.edu   
Principal Investigator: Samuel S Bederman, MD, PhD         
United States, Florida
Florida Hospital Celebration Health Not yet recruiting
Celebration, Florida, United States
Contact: Jill M Sager    407-764-4270    jillmsager@gmail.com   
Principal Investigator: Faissal Zahrawi, MD         
United States, Texas
Texas Health Presbyterian Hospital Plano Not yet recruiting
Plano, Texas, United States
Contact: Xiaobang Hu, MD, PhD    972-608-5000    Xiaobang Hu <xhu@texasback.com>   
Principal Investigator: Isador H Lieberman, MD         
Sponsors and Collaborators
Mazor Robotics
Investigators
Study Director: Doron Dinstein, MD Mazor Robotics
  More Information

Publications:
Responsible Party: Mazor Robotics
ClinicalTrials.gov Identifier: NCT02058238     History of Changes
Other Study ID Numbers: CLN105
Study First Received: February 6, 2014
Last Updated: August 25, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mazor Robotics:
Robotic-guided spinal fusions
Scoliosis
Kyphoscoliosis
Spinal deformity
Spondylosis

Additional relevant MeSH terms:
Congenital Abnormalities
Kyphosis
Scoliosis
Spondylosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on August 28, 2014