Clinical Trial of Minimally Invasive Robotic Spine Surgery

Not Applicable

Completed

• Conditions: Degenerative Lumbar Spinal Stenosis
• Interventions: Device: Renaissance, Mazor Robotics Ltd, Caesare, Israel; Procedure: free hand technique

• Registration Number: NCT02121249
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12
• Primary Completion: 2014-04
• Study First Submitted: 2014-04-15
• Study First Submitted QC: 2014-04-19
• Study First Posted: 2014-04-23
• Study Completion: 2019-12
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-29
• Last Update Posted: 2020-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Robot assisted pedicle screw fixation	Renaissance, Mazor Robotics Ltd, Caesare, Israel	posterior lumbar interbody fusion using Robot assisted pedicle screw fixation (Renaissance, Mazor Robotics Ltd, Caesare, Israel)
Free hand technique	free hand technique	using Free hand technique, posterior lumbar interbody fusion (No specific device)

Primary Outcome Measures

Name	Time	Method
Oswestry Disability Index	up to 5 year after operation, every year	Health status
Pedicle screw instrumentation accuracy	within 7 days after operation	The location of pedicle screw is evaluated by postoperative CTs in a subset of patients

Secondary Outcome Measures

Name	Time	Method
postoperative drainage	within 3 days after operation	Total drainage after surgery
Fusion rates	up to 5 year after operation	This is assessed by postoperative computed tomography at 1 year after surgery
Operation duration	After operation	Intraoperative time
time to ambulation	within 3 days after operation	immediate postop to ambulation start
SF-36	up to 5 year after operation, every year	Health status
Radiographic adjacent level degeneration	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
intraoperative blood loss	after operation	intraoperative blood loss
amount of transfusion	within 7 days after operation	Total transfusion during and after surgery
Visual Analog Pain Scale	up to 5 year after operation, every year	Pain status
Change of Oswestry Disability Index	up to 5 year after surgery, every year	Health status

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of