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A randomized parallel controlled trial of ultrasound-assisted percutaneous pedicle screw placement to reduce intraoperative radiation

A randomized parallel controlled trial of ultrasound-assisted percutaneous pedicle screw placement to reduce intraoperative radiation

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200057131
Enrollment
Unknown
Registered
2022-02-28
Start date
2022-04-01
Completion date
Unknown
Last updated
2023-10-03

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

Conditions

lumbar degenerative disease

Interventions

ultrasound-assisted group:the combination of ultrasound guidance and fluoroscopy guidance is used in percutaneous pedicle screw placement
fluoroscopic group:fluoroscopy guidance is used in percutaneous pedicle screw placement

Sponsors

Shengjing Hospital of China Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Aged >18 years and <85 years; 2. Chronic low back pain or lower limb neurological symptoms failed after 6 months of conservative treatment; 3. Single-level or double-level lumbar degenerative diseases (including lumbar spinal stenosis, lumbar instability, lumbar disc herniation and degenerative lumbar spondylolisthesis); 4. Informed consent to the study content, voluntary participation in the study and cooperation in follow-up work.

Exclusion criteria

Exclusion criteria: 1. Severe spinal deformity; 2. Pedicle dysplasia or severe sclerosis of the pedicle; 3. Severe osteoporosis; 4. BMI > 32kg/m^2; 5. Lumbar spondylolisthesis with Meyerding grade greater than 2 degrees; 6. Lumbar tumors or infectious diseases; 7. Surgical history of target or adjacent segments.

Design outcomes

Primary

MeasureTime frame
nail setting fluoroscopy time;radiation dose of screw insertion;exposure times of screw placement;

Secondary

MeasureTime frame
Oswestry disability index;insertion time of guidewire;rate of pedicle perforation;rate of facet joint violation;visual analogue scale (VAS) for back pain;complications;

Countries

China

Contacts

Public ContactLiu Da

Shengjing Hospital of China Medical University

spinecmu@163.com+86 18940257508

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 9, 2026