NCT02057744

Brief Summary

To quantify potential short- and long-term benefits of robotically-guided minimally invasive spine surgery (MIS) for adult patients with lower back degeneration, in comparison a matching group of control patients operated in a minimally invasive approach whether freehand or with image guidance or navigation techniques.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2014

Longer than P75 for all trials

Geographic Reach
1 country

9 active sites

Status
unknown

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 5, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 7, 2014

Completed
8 months until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

August 20, 2019

Status Verified

August 1, 2019

Enrollment Period

5.3 years

First QC Date

February 5, 2014

Last Update Submit

August 19, 2019

Conditions

Degenerative Spine DiseaseSpondylolisthesisSpondylosis

Keywords

Robotic-guided surgeryMinimally invasive spinal surgerySpinal fusionPedicle screws

Outcome Measures

Primary Outcomes (3)

  • Intra-operative exposure to x-ray radiation

    Reading of exposure in seconds (and KvP if available) from C-arm or other imaging system used in the operating room.

    Day of surgery

  • Surgical complications

    New neural deficits, implant-related durotomy, infection requiring return to surgery, hardware failure requiring removal, vertebral body fracture, failure to fuse

    Within first year from day of surgery

  • Revision surgeries

    All cause revisions

    1 year

Secondary Outcomes (6)

  • Pedicle screw instrumentation accuracy

    Within 1 year of surgery, if indicated by surgeon and clinically necessary

  • Incidence of pseudoarthrosis (malunion)

    Within 1 year from surgery

  • Length of convalescence

    Within 1 year of surgery

  • Times of intra-operative stages

    Day of surgery

  • Ratio of executed vs. planned screws

    Day of surgery

  • +1 more secondary outcomes

Study Arms (2)

Robotic-guided

Adult patients (21 years or older) undergoing short (4 or less consecutive vertebrae) thoracic, lumbar or lumbosacral percutaneous/minimally invasive robotic-guided spinal fixation surgery.

Freehand image-guided

Adult patients (21 years or older) undergoing short (4 or less consecutive vertebrae) thoracic, lumbar or lumbosacral percutaneous/minimally invasive image-guided freehand or navigated spinal fixation surgery.

Eligibility Criteria

Age21 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients (21 years or older) undergoing short (4 or less consecutive vertebrae) thoracic, lumbar or lumbosacral percutaneous/minimally invasive spinal fixation sugery.

You may qualify if:

  • Adult patients (age over 21 years), undergoing short (4 or less consecutive vertebrae) lumbar or lumbosacral percutaneous/MIS spinal fixation surgery.
  • May include surgeries involving iliac screws, although these screws will not be included in the data analysis.
  • Primary fusion surgery
  • Patient capable of complying with study requirements
  • Signed informed consent by patient

You may not qualify if:

  • Pregnancy
  • Revision surgery (prior laminectomy or discectomy is not excluded).
  • 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
  • Patients requiring anterior release or instrumentation
  • 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.
  • 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 (9)

Florida Hospital Celebration Health

Celebration, Florida, 34747, United States

Location

Baptist Health

Jacksonville, Florida, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Central Florida Neurosurgery Institute

Orlando, Florida, 32801, United States

Location

Southeastern Spine Center & Research Institute

Sarasota, Florida, 34232, United States

Location

The Rothman Institute

Abington, Pennsylvania, 19001, United States

Location

Tabor Orthopedics

Memphis, Tennessee, 38116, United States

Location

Atlantic Brain & Spine

Fairfax, Virginia, 22031, United States

Location

Virginia Spine Institute

Reston, Virginia, 20191, United States

Location

Related Publications (3)

  • 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

  • Kantelhardt SR, Martinez R, Baerwinkel S, Burger R, Giese A, Rohde V. Perioperative course and accuracy of screw positioning in conventional, open robotic-guided and percutaneous robotic-guided, pedicle screw placement. Eur Spine J. 2011 Jun;20(6):860-8. doi: 10.1007/s00586-011-1729-2. Epub 2011 Mar 8.

    PMID: 21384205BACKGROUND

  • Hu X, Ohnmeiss DD, Lieberman IH. Robotic-assisted pedicle screw placement: lessons learned from the first 102 patients. Eur Spine J. 2013 Mar;22(3):661-6. doi: 10.1007/s00586-012-2499-1. Epub 2012 Sep 14.

    PMID: 22975723BACKGROUND

MeSH Terms

Conditions

SpondylolisthesisSpondylosis

Condition Hierarchy (Ancestors)

SpondylolysisSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Doron Dinstein, MD

    Mazor Robotics, Ltd

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

February 5, 2014

First Posted

February 7, 2014

Study Start

October 1, 2014

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

August 20, 2019

Record last verified: 2019-08

Locations

US(9)