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Study on the efficacy and safety of lumbar pedicle screw implantation assisted by single-port non-coaxial spinal endoscopic surgery: A randomized controlled trial

Study on the efficacy and safety of lumbar pedicle screw implantation assisted by single-port non-coaxial spinal endoscopic surgery: A randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500107581
Enrollment
Unknown
Registered
2025-08-14
Start date
2025-08-31
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Spinal degenerative diseases

Interventions

UNSES Group:Pedicle screw placement was performed using UNSES technology. With the patient positioned identically to the control group, a single 2-cm incision was made posterolaterally (3-4 cm from mi
Control group:Percutaneous pedicle screw placement was performed using conventional C-arm fluoroscopy. With the patient in the prone position and abdomen

Sponsors

The First Affiliated Hospital of Guangxi Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients requiring lumbar pedicle screw fixation. ??Inclusion criteria:?? (1) Patients with surgical indications (lumbar instability, spondylolisthesis, lumbar burst fracture, severe lumbar spinal stenosis, or lumbar spondylolysis); (2) Patients showing no improvement after >6 weeks of standardized conservative treatment.

Exclusion criteria

Exclusion criteria: ??Exclusion criteria:?? (1) Patients declining participation in this study; (2) Patients with prior lumbar spine surgery; (3) Severe femoral/sciatic neuropathy with motor deficits (potentially interfering with neurological assessment accuracy); (4) Severe cardiopulmonary compromise precluding safe surgical procedures; (5) Concurrent severe osteoporosis; (6) Significant coagulopathy; (7) Active malignancies; (8) Patients with developmental pedicle anomalies.

Design outcomes

Primary

MeasureTime frame
Accuracy rate of screw placement;The number of fluoroscopy sessions during the operation;Intraoperative blood loss;Operation time;

Secondary

MeasureTime frame
VAS scores pre- and post-operation;ODI scores pre- and post-operation;Serum creatine kinase levels;Length of hospital stay;

Countries

China

Contacts

Public ContactLiu Yun

Department of Spinal and Orthopedic Surgery, the First Affiliated Hospital of Guangxi Medical University

liuyun200450250@sina.com+86 134 8119 5445

Outcome results

None listed

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