Pedicle screw placement accuracy in robot-assisted versus image-guided freehand surgery of thoraco-lumbar spine (ROBARTHRODESE): study protocol for a single-centre randomized controlled trial.
Trials
; 25(1): 106, 2024 Feb 03.
Article
in En
| MEDLINE
| ID: mdl-38310274
ABSTRACT
BACKGROUND:
Robotic spinal surgery may result in better pedicle screw placement accuracy, and reduction in radiation exposure and length of stay, compared to freehand surgery. The purpose of this randomized controlled trial (RCT) is to compare screw placement accuracy of robot-assisted surgery with integrated 3D computer-assisted navigation versus freehand surgery with 2D fluoroscopy for arthrodesis of the thoraco-lumbar spine.METHODS:
This is a single-centre evaluator-blinded RCT with a 11 allocation ratio. Participants (n = 300) will be randomized into two groups, robot-assisted (Mazor X Stealth Edition) versus freehand, after stratification based on the planned number of pedicle screws needed for surgery. The primary outcome is the proportion of pedicle screws placed with grade A accuracy (Gertzbein-Robbins classification) on postoperative computed tomography images. The secondary outcomes are intervention time, operation room occupancy time, length of stay, estimated blood loss, surgeon's radiation exposure, screw fracture/loosening, superior-level facet joint violation, complication rate, reoperation rate on the same level or one level above, functional and clinical outcomes (Oswestry Disability Index, pain, Hospital Anxiety and Depression Scale, sensory and motor status) and cost-utility analysis.DISCUSSION:
This RCT will provide insight into whether robot-assisted surgery with the newest generation spinal robot yields better pedicle screw placement accuracy than freehand surgery. Potential benefits of robot-assisted surgery include lower complication and revision rates, shorter length of stay, lower radiation exposure and reduction of economic cost of the overall care. TRIAL REGISTRATION ClinicalTrials.gov NCT05553028. Registered on September 23, 2022.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Spinal Fusion
/
Robotics
/
Surgery, Computer-Assisted
/
Robotic Surgical Procedures
/
Pedicle Screws
Type of study:
Observational_studies
Limits:
Humans
Language:
En
Journal:
Trials
Journal subject:
MEDICINA
/
TERAPEUTICA
Year:
2024
Document type:
Article
Affiliation country:
France
Country of publication:
United kingdom