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Robotic Surgery
Robotic-Assisted Spine Surgery for Spinal Conditions
N/A
Waitlist Available
Research Sponsored by Ohio State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up study completion average 2years
Awards & highlights
Study Summary
This trial will measure how accurately a robotic system guides spine screws during surgery.
Who is the study for?
This trial is for adults over 18 with conditions like scoliosis, spinal infections, trauma, cancer, or degenerative issues in the spine needing screws placed between T2-S1 vertebrae. Surgery must be done at The Ohio State University Wexner Medical Center by a study investigator.Check my eligibility
What is being tested?
The study tests how accurately pedicle screws can be inserted using the Mazor X robotic system during spine surgery. It measures any deviation from the planned screw path in thoracolumbar arthrodesis procedures.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects may include typical surgical risks such as infection, nerve damage, bleeding and pain where the screws are placed.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ study completion average 2years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~study completion average 2years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Total deviation (mm) from the pre-planned screw entry point
Secondary outcome measures
Accuracy assessment for degree of pedicle breach
Trial Design
1Treatment groups
Experimental Treatment
Group I: Arm 1Experimental Treatment1 Intervention
Single Arm. All participants undergoing posterior thoracolumbar arthrodesis procedures betweenT2-S1 in which preplanning is done using the Mazor X robotic system.
Find a Location
Who is running the clinical trial?
MedtronicIndustry Sponsor
607 Previous Clinical Trials
828,625 Total Patients Enrolled
Ohio State UniversityLead Sponsor
830 Previous Clinical Trials
505,570 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My surgery will be done at OSUWMC by a study investigator.I do not have severe heart, lung, or kidney diseases.I am 18 years old or older.I have or had a tumor in my spine.I do not speak English.I have had previous spine surgery with screws at L4-5 but am now getting an L4-S1 fusion.I need screws in my spine due to a condition or injury between my upper back and tailbone.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still vacancies available for individuals to volunteer in this clinical trial?
"As per clinicaltrials.gov's records, this medical trial is no longer enrolling patients; the initial posting was on March 5th 2021 and it was last edited on May 22nd 2023. Although not actively recruiting at this present time, there are 75 other studies that have vacancies for participants right now."
Answered by AI
Who else is applying?
What site did they apply to?
The Ohio State University Wexner Medical Center Neurological Surgery
What portion of applicants met pre-screening criteria?
Met criteria
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