Clinical Trial of Minimally Invasive Robotic Spine Surgery

Degenerative Lumbar Spinal Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02121249
• Other study ID #: Mazor_001
• Status: Completed
• Phase: N/A
• Start date: December 2013
• Est. completion date: December 2019

Study information

• Verified date: March 2020
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2019
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Degenerative Lumbar Spinal Stenosis
• Spinal Stenosis

Intervention

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

Procedure:
• free hand technique
No specific device is necessary in the "free hand technique"

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pedicle screw instrumentation accuracy	The location of pedicle screw is evaluated by postoperative CTs in a subset of patients	within 7 days after operation
Primary	Oswestry Disability Index	Health status	up to 5 year after operation, every year
Secondary	Fusion rates	This is assessed by postoperative computed tomography at 1 year after surgery	up to 5 year after operation
Secondary	Operation duration	Intraoperative time	After operation
Secondary	intraoperative blood loss	intraoperative blood loss	after operation
Secondary	postoperative drainage	Total drainage after surgery	within 3 days after operation
Secondary	amount of transfusion	Total transfusion during and after surgery	within 7 days after operation
Secondary	time to ambulation	immediate postop to ambulation start	within 3 days after operation
Secondary	Change of Oswestry Disability Index	Health status	up to 5 year after surgery, every year
Secondary	Visual Analog Pain Scale	Pain status	up to 5 year after operation, every year
Secondary	SF-36	Health status	up to 5 year after operation, every year
Secondary	Radiographic adjacent level degeneration	Radiographic changes according to UCLA, vertebral body translation, motion change, segmental kyphosis or lordosis, disc height changes	up to 5 year after operation, every year