Clinical Trial for the Application of Robotic System in Spinal Surgery

Study Overview
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Brief Summary
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This randomized controlled study was designed to evaluate the accuracy, safety and clinical outcomes of the robot assisted spinal surgery.

Detailed Description
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Robot assisted operation is new for spinal surgery, in this study, we will evaluate the accuracy, safety and clinical outcomes compared with traditional free hand operation and navigation assisted operation.

Official Title
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Clinical Trial for the Application of Robotic System in Spinal Surgery: a Randomized Controlled Study

Conditions
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Safety, Robotic Surgical Procedures, Spinal Surgery

Intervention / Treatment
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* Device: TIANJI Robot
* Device: Fluoroscopy
* Device: Navigation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Spinal disease required for screw fixation；signed the inform consent Exclusion Criteria: Patients with severe osteoporosis; patients with old fractures; patients with pedicle deformity; patients with severe systemic diseases; patients with coagulation disorders; patients who are considered unsuitable for this trail by the clinician.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Robot-assisted surgery group Free-hand surgery group Navigation-assisted surgery group
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robot assisted surgery group<br>Spinal surgery using TIANJI Robot system. | Device: TIANJI Robot<br>* A robotic system for spinal surgery<br>|
| Active Comparator: Free hand surgery group<br>Spinal surgery using fluoroscopy-based free hand technique | Device: Fluoroscopy<br>* For fluoroscopy-based free hand surgery<br>|
| Active Comparator: Navigation-assisted surgery group<br>Spinal surgery using Navigation-assisted technique | Device: Navigation<br>* For navigation-assisted spinal surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Screw guide wire adjustment times | The adjustment times of screw guide wire during surgery | During surgery | 
| Screw adjustment times | The adjustment times of screw during surgery | During surgery | 
| Deviation of screw | The deviation between the actual position of screw and the preoperative designed position | Up to 12 weeks | 
| Perforation rate of screw | Rate of screws breaching out pedicles on postoperative CT image | Up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operation time | Operation time | During surgery | 
| Blood loss | Blood loss during surgery | During surgery | 
| Complications | Complications after surgery | Up to 4 weeks | 
| Hospital stay after surgery | Hospital stay after surgery | Up to 4 weeks | 
| Hospitalization costs | Hospitalization costs | Up to 4 weeks | 
| Visual Analogue Scale | Visual Analogue Scale | 3 days before surgery | 
| Visual Analogue Scale | Visual Analogue Scale | 3 days after surgery | 
| Neck Disability Index | Neck Disability Index | 3 days before surgery | 
| Neck Disability Index | Neck Disability Index | 3 days after surgery | 
| Oswestry Disability Index | Oswestry Disability Index | 3 days before surgery | 
| Oswestry Disability Index | Oswestry Disability Index | 3 days after surgery | 
| modified Japanese orthopaedic association score | modified Japanese orthopaedic association score | 3 days before surgery | 
| modified Japanese orthopaedic association score | modified Japanese orthopaedic association score | 3 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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robot-assisted surgery, pedicle screw, spine