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Completed

NCT Number: NCT02121249

Clinical Trial of Minimally Invasive Robotic Spine Surgery

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.

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Key information

Conditions

Degenerative Lumbar Spinal Stenosis

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Bundang Hospital

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Renaissance, Mazor Robotics Ltd, Caesare, Israel

Device

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

Other names: (Renaissance, Mazor Robotics Ltd, Caesare, Israel)

Free hand technique

Procedure

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

Primary outcomes

  1. Pedicle screw instrumentation accuracy

    Time frame: within 7 days after operation

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

  2. Oswestry Disability Index

    Time frame: up to 5 year after operation, every year

    Health status

Secondary outcomes

  1. Fusion rates

    Time frame: up to 5 year after operation

    This is assessed by postoperative computed tomography at 1 year after surgery

  2. Operation duration

    Time frame: After operation

    Intraoperative time

  3. intraoperative blood loss

    Time frame: after operation

    intraoperative blood loss

  4. postoperative drainage

    Time frame: within 3 days after operation

    Total drainage after surgery

  5. amount of transfusion

    Time frame: within 7 days after operation

    Total transfusion during and after surgery

  6. time to ambulation

    Time frame: within 3 days after operation

    immediate postop to ambulation start

  7. Change of Oswestry Disability Index

    Time frame: up to 5 year after surgery, every year

    Health status

  8. Visual Analog Pain Scale

    Time frame: up to 5 year after operation, every year

    Pain status

  9. SF-36

    Time frame: up to 5 year after operation, every year

    Health status

  10. Radiographic adjacent level degeneration

    Time frame: up to 5 year after operation, every year

    Radiographic changes according to UCLA, vertebral body translation, motion change, segmental kyphosis or lordosis, disc height changes

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Randomized Comparative Trial of Minimally Invasive Robotic vs. Freehand in Short Adult Degenerative Spinal Fusion Surgeries

Important dates

Study start
2013
Primary completion
2014
Study completion
2019
First posted
Apr 23, 2014
Registry last updated
Mar 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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