Clinical trial NCT02121249: Clinical Trial of Minimally Invasive Robotic Spine Surgery
Official title: Randomized Comparative Trial of Minimally Invasive Robotic vs. Freehand in Short Adult Degenerative Spinal Fusion Surgeries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Degenerative Lumbar Spinal Stenosis
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2014-04-23
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Pedicle screw instrumentation accuracy
timeFrame: within 7 days after operation
measure: Oswestry Disability Index
timeFrame: up to 5 year after operation, every year
Secondary outcomes:
measure: Fusion rates
timeFrame: up to 5 year after operation
measure: Operation duration
timeFrame: After operation
measure: intraoperative blood loss
timeFrame: after operation
measure: postoperative drainage
timeFrame: within 3 days after operation
measure: amount of transfusion
timeFrame: within 7 days after operation
measure: time to ambulation
timeFrame: within 3 days after operation
measure: Change of Oswestry Disability Index
timeFrame: up to 5 year after surgery, every year
measure: Visual Analog Pain Scale
timeFrame: up to 5 year after operation, every year
measure: SF-36
timeFrame: up to 5 year after operation, every year
measure: Radiographic adjacent level degeneration
timeFrame: up to 5 year after operation, every year
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Ho-Joong Kim, MD
role: PRINCIPAL_INVESTIGATOR
References: