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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robot assisted pedicle screw fixation | Experimental | posterior lumbar interbody fusion using Robot assisted pedicle screw fixation (Renaissance, Mazor Robotics Ltd, Caesare, Israel) |
|
| Free hand technique | Active Comparator | using Free hand technique, posterior lumbar interbody fusion (No specific device) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Renaissance, Mazor Robotics Ltd, Caesare, Israel | Device | Renaissance (Mazor Robotics Ltd, Caesare, Israel) is the name of the robot |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pedicle screw instrumentation accuracy | The location of pedicle screw is evaluated by postoperative CTs in a subset of patients | within 7 days after operation |
| Oswestry Disability Index | Health status | up to 5 year after operation, every year |
| Measure | Description | Time Frame |
|---|---|---|
| Fusion rates | This is assessed by postoperative computed tomography at 1 year after surgery | up to 5 year after operation |
| Operation duration | Intraoperative time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ho-Joong Kim, MD | Seoul National University Bundang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | 463-707 | South Korea |
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| free hand technique | Procedure | No specific device is necessary in the "free hand technique" |
|
| After operation |
| intraoperative blood loss | intraoperative blood loss | after operation |
| postoperative drainage | Total drainage after surgery | within 3 days after operation |
| amount of transfusion | Total transfusion during and after surgery | within 7 days after operation |
| time to ambulation | immediate postop to ambulation start | within 3 days after operation |
| Change of Oswestry Disability Index | Health status | up to 5 year after surgery, every year |
| Visual Analog Pain Scale | Pain status | up to 5 year after operation, every year |
| SF-36 | Health status | up to 5 year after operation, every year |
| 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 |