Prospective Robotic-Guided Registry of Spine Surgery (PRoGRSS)

  • STATUS
    Recruiting
  • End date
    Aug 31, 2023
  • participants needed
    1000
  • sponsor
    The National Spine Health Foundation
Updated on 24 March 2022

Summary

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

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.

Details
Condition Spinal Disease
Treatment Robotic-guided spine surgery
Clinical Study IdentifierNCT05181098
SponsorThe National Spine Health Foundation
Last Modified on24 March 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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