Clinical trial NCT05181098: Prospective Robotic-Guided Registry of Spine Surgery
Official title: Prospective Robotic-Guided Registry of Spine Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Spinal Disease
Keywords: Robotic-guided spine surgery
Lead sponsor: The National Spine Health Foundation
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2022-01-06
Enrollment: 1000
Sex: ALL
Minimum age (years): 12
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any pediatric, adolescent or adult patient undergoing robotic-guided spine surgery, ages 12-80.

Brief summary: This study aims to combine multi-center data of robotic assisted spine surgery, to evaluate the true scope of this advancing technology.

Detailed description: What is the impact on clinical and patient-reported outcomes for participants who undergo robot assisted surgery? This will be the first multi-center study to prospectively collect data on robotic assisted spine surgery outcomes. The primary objective of this study will be to facilitate quantification of potential short- and long-term benefits of robotically guided spine surgeries.

It is hypothesized that use of robotic guidance during spinal instrumentation will have numerous short- and long-term benefits to both participant and surgeon. Expected benefits include improved surgical and clinical outcomes, lower incidence of procedure-related adverse events (e.g., fewer new neurological deficits, implant-related durotomies, and implant misplacements), improved implant accuracy, lower intraoperative radiation exposure, and lower reoperation rates, when compared to the published literature.

The secondary objective of this study is to assess the clinical performance of robotic instrumentation as per the pre-operative plan. To this end, data on a number of common clinical metrics will be analyzed to determine the extent to which they are affected by the use of robotic guidance during implantation.

Eligibility criteria: Inclusion Criteria:

* Any pediatric, adolescent or adult patient
* Undergoing open or MIS robotic-guided spine surgery using the Mazor Core Technology.

Exclusion Criteria:

* Pregnancy
* active infection
* malignancy
* primary abnormalities of bone
* primary muscle diseases (e.g., muscular dystrophy)
* neurologic diseases
* spinal cord abnormalities/lesions
* paraplegia.

Primary outcomes:
measure: To evaluate the success of robotic-guided spine surgery, from planning to execution.
timeFrame: 1 year after surgery
measure: To evaluate the success of robotic-guided spine surgery, by screw placement accuracy.
timeFrame: 1 year after surgery
measure: To evaluate the success of robotic-guided spine surgery, by revision surgery rates.
timeFrame: 1 year after surgery
measure: To evaluate the success of robotic-guided spine surgery, by the radiation exposure.
timeFrame: 1 year after surgery
Secondary outcomes:
measure: To evaluate clinical outcomes, as determined by all cause revisions
timeFrame: 1 year after surgery
measure: To evaluate clinical outcomes, by surgical complications
timeFrame: 1 year after surgery
measure: To evaluate clinical outcomes, by patient reported outcome measures
timeFrame: 1 year after surgery
measure: To evaluate clinical outcomes, by patient disability rating
timeFrame: 1 year after surgery
Other outcomes:
Locations:
city: Reston
country: United States
facility: National Spine Health Foundation
state: Virginia
Study officials:
affiliation: Virginia Spine Institute
name: Christopher Good, MD
role: PRINCIPAL_INVESTIGATOR
References: