Clinical Trial for the Application of Robotic System in Spinal Surgery

Beijing Jishuitan Hospital

Status: Unknown

Conditions: Spinal Surgery; Robotic Surgical Procedures; Safety

Treatments: Device: Navigation; Device: Fluoroscopy; Device: TIANJI Robot

Study type: Interventional

Funder types: Other

Identifiers

NCT03512379

JST-201508

Details and patient eligibility

About

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

Full description

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.

Enrollment: 1,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,000 participants in 3 patient groups

Robot assisted surgery group

Experimental group

Description:

Spinal surgery using TIANJI Robot system.

Treatment:

Device: TIANJI Robot

Free hand surgery group

Active Comparator group

Description:

Spinal surgery using fluoroscopy-based free hand technique

Treatment:

Device: Fluoroscopy

Navigation-assisted surgery group

Active Comparator group

Description:

Spinal surgery using Navigation-assisted technique

Treatment:

Device: Navigation