NuvaMap O.R.
DeviceClinical imaging software used to assess intraoperative spinal alignment
NCT Number: NCT02606695
A comprehensive approach to the evaluation of alignment in spinal surgery patients - through preoperative planning, intraoperative assessment, and postoperative confirmation - has not been well-studied. This study aims to assess the value of such planning through clinical and radiographic outcomes.
Looking for future studies?
Notify Me18 year and older
All sexes
Observational
Scripps Clinic Medical Group, La Jolla, California, United States
Preoperative planning using tools such as NuvaMapTM (NuVasive®, Inc., San Diego, CA) enable a surgeon to preoperatively evaluate these alignment parameters and simulate a patient-specific plan using a combination of procedures, techniques, and implants. Once in the operating room, realignment objectives can be verified from a lateral fluoroscopic image in real-time using NuvaMap O.R. (NuVasive, Inc.), a software application integrated with the NVM5® neuromonitoring platform (NuVasive, Inc.). This real-time verification allows for confirmation and subsequent changing of the plan as necessary. The objective of this study is to validate the utility and effectiveness of comprehensive surgical planning in restoring and preserving sagittal alignment through the collection of clinical and radiographic outcomes.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Clinical imaging software used to assess intraoperative spinal alignment
Clinical imaging software used to assess spinal alignment
Time frame: Postoperative (3 months)
The incidence of a change in plan (pre- or intraoperative) based on alignment measurement feedback, and the consequential achievement of postoperative (at 3 months) alignment relative to planned goals.
NuVasive
Industry
A Prospective Multicenter Study Evaluating the Clinical and Radiographic Outcomes of Thoracolumbar Spine Surgery When Comprehensive Sagittal Alignment Surgical Planning is Used
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05887375
Female Urogenital Diseases, Female Urogenital Diseases and Pregnancy Complications
Columbia, Missouri, United States
View Trial DetailsNCT06210061
Dexmedetomidine, Fentanyl
Cairo, Egypt
View Trial DetailsNCT04473508
AdverseEvent, Morphine
Nîmes, Gard, France
View Trial DetailsNCT07238101
Hemodynamic Stability During Anesthesia, Spine Surgery
Medan, North Sumatra, Indonesia
View Trial Details