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Minimally invasive spinal surgery robot positioning system is used to complete a prospective, randomized controlled non-inferior clinical trial of pedicle puncture in PVP under local anesthesia

Minimally invasive spinal surgery robot positioning system is used to complete a prospective, randomized controlled non-inferior clinical trial of pedicle puncture in PVP under local anesthesia

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000041510
Enrollment
Unknown
Registered
2020-12-27
Start date
2021-01-01
Completion date
Unknown
Last updated
2021-03-15

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

Conditions

Osteoporotic vertebral compression fractures

Interventions

Robotic group:Robot-assisted
Freehand group:Freehand

Sponsors

Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Male > 60 years old, female > 55 years old; the clinical diagnosis of thoracolumbar fractures was determined by orthopedic doctors, and they were to receive PVP surgery; 2. Patients with osteoporosis diagnosed by bone mineral density (BMD); 3. Patients with fresh fracture indicated by MRI examination; 4. CT examination showed that there was no intraspinal space occupying and spinal cord compression; 5. Patients without lower extremity neurological symptoms; 6. The patients who are willing to participate in this study should sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with pathological fracture; 2. Patients with vertebral burst fracture or compression fracture with vertebral posterior wall rupture; 3. Patients with old thoracolumbar fractures; 4. Patients with poor physical condition, unable to tolerate surgery or cooperate with surgery; 5. Patients who did not receive surgical treatment due to various reasons; 6. Patients with mental illness, etc., who are expected to lead to poor compliance; 7. Patients considered unsuitable by clinical institutions.

Design outcomes

Primary

MeasureTime frame
Oswestry Disability Index scale;Visual Analogue Scale;

Secondary

MeasureTime frame
Incidence and location of bone cement leakage;Diffusion of bone cement;The difference between the implantation position of puncture needle and the planned position;Operation time;Perspective time;Bleeding volume;

Countries

China

Contacts

Public ContactZhang Lihai

Chinese PLA General Hospital

Zhanglihai74@qq.com+86 13810745151

Outcome results

None listed

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