Prospective Robotic-Guided Registry of Spine Surgery

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational [Patient Registry]
Eligible Ages	12 Years - 80 Years
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05181098
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	The National Spine Health Foundation
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Christopher Good, MD
Principal Investigator Affiliation	Virginia Spine Institute
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, Industry
Overall Status	Enrolling by invitation
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Spinal Disease

Additional Details

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.

Arms & Interventions

Arms

: Robotic-guided surgery group

Any pediatric, adolescent or adult patient undergoing robotic-guided spine surgery, ages 12-80.

Interventions

Procedure: - Robotic-guided spine surgery

The Mazor X Stealth Edition robotic platform will be used to guide posterior instrumentation during spine fusion surgery.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

National Spine Health Foundation, Reston, Virginia

Status

Address

National Spine Health Foundation

Reston, Virginia, 20191

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