Ignite Creation Date:
2024-05-06 @ 9:29 AM
Last Modification Date:
2024-10-26 @ 12:15 PM
Study NCT ID:
NCT02998060
Status:
WITHDRAWN
Last Update Posted:
2018-10-22
First Post:
2016-12-11
Brief Title:
Clinical Evidence of Robot Guided vs Navigated vs Free Hand Lumbar Spinal Fusion
Sponsor:
Marc Schröder
Organization:
Bergman Clinics
Study Overview
Official Title:
Clinical Evidence of Robot Guided vs Navigated vs Free Hand Lumbar Spinal Fusion
Status:
WITHDRAWN
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Change in study design Randomization not feasible
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Computer-based navigation systems were first introduced to spine surgery in 1995 and while they have been long established as standards in certain cranial procedures they have not been similarly adopted in spine surgery Designed to overcome some of the limitations of navigation-based technologies robot-guided surgical systems have become commercially available to surgeons worldwideThese systems are rapidly challenging the gold standards
The aim is to conduct a prospective randomized controlled trial The randomized variable will be the screw placement technique used One arm will be treated with lumbar fusion using robotic guidance RG one arm will receive the same procedure but with a free hand technique FH and the third arm will use navigation NV CT or Fluoroscopy-assisted Intraoperative screw revisions and revision surgery for screw malposition as well as clinical patient-reported outcomes to identify any such differences between these methods of screw insertion will be assessed
The aim is to conduct a prospective randomized controlled trial The randomized variable will be the screw placement technique used One arm will be treated with lumbar fusion using robotic guidance RG one arm will receive the same procedure but with a free hand technique FH and the third arm will use navigation NV CT or Fluoroscopy-assisted Intraoperative screw revisions and revision surgery for screw malposition as well as clinical patient-reported outcomes to identify any such differences between these methods of screw insertion will be assessed
Detailed Description:
A decade ago minimally invasive surgery MIS was considered a promising development in spine surgery yet the value of the pioneering technologies was questionable With the growing number of experienced MIS surgeons the influx of evidence in favour of MIS is rapidly increasing This makes a compelling argument towards MIS offering distinct clinical benefits over open approaches in terms of blood loss length of stay rehabilitation cost-effectiveness and perioperative patient comfort Due to the limited or inexistent line-of-sight in MIS procedures surgeons need to rely on imaging navigation and guidance technologies to operate in a safe and efficient manner Therefore a plethora of new and ever improving navigational systems have been developed These systems allow a consistent level of safety and accuracy on par with results achieved by very experienced free hand surgeons with a reasonably short learning curve
Computer-based navigation systems were first introduced to spine surgery in 1995 and while they have been long established as standards in certain cranial procedures they have not been similarly adopted in spine surgery Designed to overcome some of the limitations of navigation-based technologies robot-guided surgery has become commercially available to surgeons worldwide like SpineAssist Mazor Robotics Ltd Caesarea Israel and the recently launched ROSA Spine Zimmer-Biomet Warsaw Indiana USA These systems are rapidly challenging the gold standards
SpineAssist and its upgraded version the Renaissance provides a stable drilling platform and restricts the surgeons natural full range of motion to 2 degrees of freedom updown motion and yaw in the cannula The systems guidance unit moves into the trajectory based on exact preoperative planning of pedicle screws while accounting for changes in intervertebral relationships such as due to distraction cage insertion or changes between the supine patient position in the preoperative CT and the prone patient on the operating table Published evidence on robot-guided screw placement has demonstrated high levels of accuracy with most reports ranging around 98 of screws placed within the pedicle or with a cortical encroachment of less than 2 mm
Although the reliability and accuracy of robot-guided spine surgery have been established the actual benefits for the patient in terms of clinical outcomes and revision surgeries remain unknown
The investigators recently conducted a cohort study that showed some evidence that robotic guidance lowers the rate of intraoperative screw revisions and implant related reoperations compared to free hand procedures while achieving comparable clinical outcomes Now these factors among others have to be assessed on a higher level of evidence This would be to date the first randomized controlled trial comparing clinical patient reported outcomes of robotic guided RG pedicle screw placement vs navigated NV vs free hand FH pedicle screw placement
The investigators aim is to conduct a prospective randomized controlled trial The randomized variable will be the screw placement technique used One arm will be treated with lumbar fusion using robotic guidance RG one arm will receive the same procedure but with a free hand technique FH and the third arm will use navigation NV CT or Fluoroscopy-assisted
Computer-based navigation systems were first introduced to spine surgery in 1995 and while they have been long established as standards in certain cranial procedures they have not been similarly adopted in spine surgery Designed to overcome some of the limitations of navigation-based technologies robot-guided surgery has become commercially available to surgeons worldwide like SpineAssist Mazor Robotics Ltd Caesarea Israel and the recently launched ROSA Spine Zimmer-Biomet Warsaw Indiana USA These systems are rapidly challenging the gold standards
SpineAssist and its upgraded version the Renaissance provides a stable drilling platform and restricts the surgeons natural full range of motion to 2 degrees of freedom updown motion and yaw in the cannula The systems guidance unit moves into the trajectory based on exact preoperative planning of pedicle screws while accounting for changes in intervertebral relationships such as due to distraction cage insertion or changes between the supine patient position in the preoperative CT and the prone patient on the operating table Published evidence on robot-guided screw placement has demonstrated high levels of accuracy with most reports ranging around 98 of screws placed within the pedicle or with a cortical encroachment of less than 2 mm
Although the reliability and accuracy of robot-guided spine surgery have been established the actual benefits for the patient in terms of clinical outcomes and revision surgeries remain unknown
The investigators recently conducted a cohort study that showed some evidence that robotic guidance lowers the rate of intraoperative screw revisions and implant related reoperations compared to free hand procedures while achieving comparable clinical outcomes Now these factors among others have to be assessed on a higher level of evidence This would be to date the first randomized controlled trial comparing clinical patient reported outcomes of robotic guided RG pedicle screw placement vs navigated NV vs free hand FH pedicle screw placement
The investigators aim is to conduct a prospective randomized controlled trial The randomized variable will be the screw placement technique used One arm will be treated with lumbar fusion using robotic guidance RG one arm will receive the same procedure but with a free hand technique FH and the third arm will use navigation NV CT or Fluoroscopy-assisted
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None