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Clinical Trial of Minimally Invasive Robotic Spine Surgery

Seoul National University logo

Seoul National University

Status

Completed

Conditions

Degenerative Lumbar Spinal Stenosis

Treatments

Device: Renaissance, Mazor Robotics Ltd, Caesare, Israel
Procedure: free hand technique

Study type

Interventional

Funder types

Other

Identifiers

NCT02121249
Mazor_001

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

40 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

40 participants in 2 patient groups

Robot assisted pedicle screw fixation
Experimental group
Description:
posterior lumbar interbody fusion using Robot assisted pedicle screw fixation (Renaissance, Mazor Robotics Ltd, Caesare, Israel)
Treatment:
Device: Renaissance, Mazor Robotics Ltd, Caesare, Israel
Free hand technique
Active Comparator group
Description:
using Free hand technique, posterior lumbar interbody fusion (No specific device)
Treatment:
Procedure: free hand technique

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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