NCT02058238

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 10, 2014

Completed
8 months until next milestone

Study Start

First participant enrolled

October 3, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

October 5, 2020

Status Verified

September 1, 2020

Enrollment Period

5 months

First QC Date

February 6, 2014

Last Update Submit

September 30, 2020

Conditions

ScoliosisKyphosisKyphoscoliosisSpinal DeformitySpondylosis

Keywords

Robotic-guided spinal fusionsScoliosisKyphoscoliosisSpinal deformitySpondylosis

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (12)

  • Deformity correction as measured on plain radiographs

    Within 2 years from surgery

  • Clinical outcome measures assessed using health-related quality of life questionnaires

    up to 10 years post-operative

  • Pedicle screw instrumentation accuracy

    Within 1 year of surgery

  • Length of convalescence

    Within 2 years of surgery

  • Ratio of executed vs. planned screws

    Day of surgery

  • +7 more secondary outcomes

Study Arms (4)

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.

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Related Publications (2)

  • 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.

    PMID: 23584231BACKGROUND

  • 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.

    PMID: 21079498BACKGROUND

MeSH Terms

Conditions

ScoliosisKyphosisSpondylosis

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Doron Dinstein, MD

    Mazor Robotics

    STUDY DIRECTOR
0

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2014

First Posted

February 10, 2014

Study Start

October 3, 2014

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

October 5, 2020

Record last verified: 2020-09

Locations

US(1)