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A single-group multicenter clinical study to evaluate the safety and efficacy of robotic positioning systems for minimally invasive spine surgery in the fabrication of internal pedicle surgical channels during spine surgery

A single-group multicenter clinical study to evaluate the safety and efficacy of robotic positioning systems for minimally invasive spine surgery in the fabrication of internal pedicle surgical channels during spine surgery

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000040333
Enrollment
Unknown
Registered
2020-11-28
Start date
2020-11-17
Completion date
Unknown
Last updated
2021-02-16

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

Conditions

spinal diseases

Interventions

Case series:The robot positioning system for minimally invasive spine surgery was used to complete the fabrication of the pedicle surgical channel in spinal surgery

Sponsors

First Affiliated Hospital of Xinjiang Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 18-75 years (including 18 and 75 years old), regardless of gender; 2. In line with the surgical indications of spinal diseases (such as thoracolumbar fracture and dislocation, degenerative intervertebral disc change, spondylolisthesis, etc.), minimally invasive or minimally invasive is proposed Patients with intracranial pedicle surgical channels of thoracic and lumbar vertebrae guided by C-arm under open conditions; 3. The site of spinal disease to be operated is below 10 (including 10) chest; 4, the American society of anesthesiologists ASA class I/II; 5. Subjects are willing and able to sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. The patient is mentally incapable or unable to understand the requirements of participating in the study; 2. Allergy to metals, allergic constitution or allergic to multiple drugs; 3. Pregnant and lactating women; 4. Subjects are unwilling or unable to restrict activities or follow medical advice; 5. The patient is critically ill and the expected survival time is not more than 2 years, so it is difficult to make an exact evaluation on the effectiveness and safety of the device; 6. Patients with vertebral pedicle development malformation; 7. Severe scoliosis (Cobb Angle >30 degree); 8. Patients with severe osteoporosis; 9. Vertebra tumor patients; 10. Other researchers think it is not suitable for the candidates.

Design outcomes

Primary

MeasureTime frame
Accuracy of channel positioning;

Secondary

MeasureTime frame
The difference between the entry point position and the planning position;Difference between dead center and planned location;A-level accuracy of channel positioning;Positioning time of single guide wire;Number of X-ray exposures;Instrument performance evaluation;

Countries

China

Contacts

Public ContactLi Cao

First Affiliated Hospital of Xinjiang Medical University

xjbone@163.com+86 13909915960

Outcome results

None listed

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