An evaluation of a spinal minimally invasive surgical robot positioning system for spinal arches in spinal surgery Multi-center, randomized, blinded assessment of safety and effectiveness of intra-root surgical channel fabrication Controlled non-inferiority clinical trial

Controlled clinical study of a spinal minimally invasive surgical robot

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1900028678

Enrollment

Unknown

Registered

2019-12-30

Start date

2018-07-01

Completion date

Unknown

Last updated

2020-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

spinal disease or trauma

Interventions

Experimental group:Robotic positioning using spinal minimally invasive surgery

Control group:Conventional operation

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 18-75 years old; 2. Patients in accordance with the indications for spinal disease or trauma surgery (such as thoracolumbar fractures and dislocations, degenerative changes in the intervertebral disc, spondylolisthesis, etc.); 3. Surgical site is planned to be below the thoracic vertebra 10 (including chest 10); 4. ASA grade of American Association of Anesthesiologists I, II; 5. Subjects are willing and able to sign informed consent.

Exclusion criteria

Exclusion criteria: 1. The patient is mentally incapable or unable to understand the requirements for participating in the study; 2. People with metal allergies, allergies or allergies to various drugs; 3. pregnant and lactating women; 4. Patients are unwilling or unable to restrict activities or follow medical advice; 5. Those who are critically ill and whose life expectancy is not more than 2 years, and it is difficult to make an accurate evaluation of the effectiveness and safety of the device; 6. pedicle malformation; 7. People with severe scoliosis (Cobb angle> 30 degree C); 8. Patients with severe osteoporosis; 9. Patients with vertebral tumors; 10. Other researchers consider it unsuitable for inclusion.

Design outcomes

Primary

Measure	Time frame
Surgical channel positioning accuracy;	—

Secondary

Measure	Time frame
The difference between the entry point location and the planned location;The difference between the end position and the planned position;Level A positioning precision rate of channel positioning;positioning time for a single guide pin;Times of X-ray exposure;Device performance evaluation;	—

Countries

China

Contacts

Public ContactZhang Lihai

Department of Orthopaedics, Chinese PLA General Hospital

zhanglihai74@qq.com+86 13810745151

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026