NCT02121249

Brief Summary

The purpose of this study was to quantify potential short- and long-term benefits of robotically-guided minimally invasive spine surgery in instrumentation of degenerative lumbar or lumbosacral spine disease in adult patients, in comparison to instrumentation in a matching cohort of control patients performed using conventional freehand technique.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

December 1, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

April 15, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 23, 2014

Completed
5.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

March 31, 2020

Status Verified

March 1, 2020

Enrollment Period

4 months

First QC Date

April 15, 2014

Last Update Submit

March 29, 2020

Conditions

Degenerative Lumbar Spinal Stenosis

Outcome Measures

Primary Outcomes (2)

  • Pedicle screw instrumentation accuracy

    The location of pedicle screw is evaluated by postoperative CTs in a subset of patients

    within 7 days after operation

  • Oswestry Disability Index

    Health status

    up to 5 year after operation, every year

Secondary Outcomes (10)

  • Fusion rates

    up to 5 year after operation

  • Operation duration

    After operation

  • intraoperative blood loss

    after operation

  • postoperative drainage

    within 3 days after operation

  • amount of transfusion

    within 7 days after operation

  • +5 more secondary outcomes

Study Arms (2)

Robot assisted pedicle screw fixation

EXPERIMENTAL

posterior lumbar interbody fusion using Robot assisted pedicle screw fixation (Renaissance, Mazor Robotics Ltd, Caesare, Israel)

Device: Renaissance, Mazor Robotics Ltd, Caesare, Israel

Free hand technique

ACTIVE COMPARATOR

using Free hand technique, posterior lumbar interbody fusion (No specific device)

Procedure: free hand technique

Interventions

Renaissance, Mazor Robotics Ltd, Caesare, IsraelDEVICE

Renaissance (Mazor Robotics Ltd, Caesare, Israel) is the name of the robot

Also known as: (Renaissance, Mazor Robotics Ltd, Caesare, Israel)
Robot assisted pedicle screw fixation
free hand techniquePROCEDURE

No specific device is necessary in the "free hand technique"

Free hand technique

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients (age from 40 years to 85 years), undergoing short (below 3 consecutive vertebrae) lumbar or lumbosacral fixation surgery.
  • Primary surgery and revision surgery
  • Patient capable of complying with study requirements
  • Signed informed consent of patient or legal guardian

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, neurofibroma)
  • Spinal cord abnormalities with any neurologic symptoms or signs
  • Spinal cord lesions requiring neurosurgical interventions, such as hydromyelia
  • Paraplegia
  • 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 (or legal guardian, when applicable) cannot or will not sign informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

Study Officials

  • Ho-Joong Kim, MD

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 15, 2014

First Posted

April 23, 2014

Study Start

December 1, 2013

Primary Completion

April 1, 2014

Study Completion

December 1, 2019

Last Updated

March 31, 2020

Record last verified: 2020-03

Locations

KR(1)