Prospective, Observational Registry of Renaissance-guided Spine Surgeries
Status: | Terminated |
---|---|
Conditions: | Orthopedic, Orthopedic, Orthopedic, Women's Studies |
Therapuetic Areas: | Orthopedics / Podiatry, Reproductive |
Healthy: | No |
Age Range: | 6 - 90 |
Updated: | 8/19/2018 |
Start Date: | February 2015 |
End Date: | December 30, 2016 |
To establish an observational registry for systematic collection of clinical data from
Renaissance-guided spine surgeries.
Renaissance-guided spine surgeries.
The key objective of this observational registry is to prospectively collect data to
facilitate the quantification of potential short- and long-term benefits of
Renaissance-guided spine surgery. It establishes a common framework for collaboration between
surgeons performing Renaissance-guided spine surgeries in either minimally invasive (MIS) or
open surgical approaches.
The main endpoints that will be collected are surgical endpoints (e.g. complication rates),
patient reported outcomes (e.g. VAS, ODI), imaging parameters (e.g. coronal and sagittal
alignment, mainly in reconstructive surgeries for spinal deformities) and technical
parameters (e.g. use of intraoperative fluoroscopy, ratio of planned vs. executed screws).
facilitate the quantification of potential short- and long-term benefits of
Renaissance-guided spine surgery. It establishes a common framework for collaboration between
surgeons performing Renaissance-guided spine surgeries in either minimally invasive (MIS) or
open surgical approaches.
The main endpoints that will be collected are surgical endpoints (e.g. complication rates),
patient reported outcomes (e.g. VAS, ODI), imaging parameters (e.g. coronal and sagittal
alignment, mainly in reconstructive surgeries for spinal deformities) and technical
parameters (e.g. use of intraoperative fluoroscopy, ratio of planned vs. executed screws).
Inclusion Criteria:
Patients undergoing spinal surgery in a posterior approach where the surgeon used
Renaissance surgical guidance system.
Patient capable of complying with study requirements. Signed informed consent by patient.
Exclusion Criteria:
Any significant disease or disorder which, in the opinion of the Investigator, may either
put the participant 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 cannot or will not sign
informed consent.
We found this trial at
4
sites
Houston, Texas 77063
Principal Investigator: Richard R.M. Francis, MD
Phone: 7133837100
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Jacksonville, Florida 32207
Principal Investigator: Andrew Cannestra, MD
Phone: 904-398-0125
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Memphis, Tennessee 38116
Principal Investigator: Samuel R Schroerlucke, MD
Phone: 901-767-8662
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Reston, Virginia 20190
Principal Investigator: Christopher R Good, MD
Phone: 703-766-5405
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