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The 3D navigation template in guiding unilateral lumbar pedicle screw with contralateral translaminar facet screw fixation: A randomized controlled trial

The 3D navigation template in guiding unilateral lumbar pedicle screw with contralateral translaminar facet screw fixation: A randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IDR-17010466
Enrollment
Unknown
Registered
2017-01-18
Start date
2017-11-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

lumbar degenerative conditions

Interventions

1:3D navigation template
2:X???

Sponsors

The Second Affiliated Hospital of Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Adult patients with age between 18 and 60 years old; 2. All of participants will be informed consent; 3. Chronic low back pain or combined with neurological symptoms of lower extremities; 4. Single-segment lower lumbar vertebral disease (Including lumbar spinal cannal stenosis, foraminal stenosis, segmental instability, lumbar disc herniation, and painful disc degeneration (back disc)); 5. Inefficacy after strict conservative treatment for more than 6 months.

Exclusion criteria

Exclusion criteria: 1. Serious deformity of lumbar vertebrae; 2. Dysplasia of lumbar pedicle or vertebral laminar; 3. Obvious osteoporosis of lumbar vertebrae; 4. Metabolic bone diseases such as osteomalacia or Pagets disease; 5. Spondylolisthesis > grade 2 (Meyerding); 6. Caudaequina injury or severe radiculopathy; 7. Post inflammatory instability of the vertebral spine; 8. Body mass index > 30; 9. Immunologic diseases or Metabolicsyndrome; 10. Therapy with systemic corticosteroids or immunosuppressants; 11. Current using Coumadin (or Warfarin) or Heparin therapy for more than 6 months at the time of operation.

Design outcomes

Primary

MeasureTime frame
wound incision length;operative time;intra-operative blood loss;Screw angles;the position of the screws;

Secondary

MeasureTime frame
Visual Analog Scale for back pain (VAS back);Visual Analog Scale for leg pain (VAS leg);Oswestry Disability Index (ODI);

Countries

China

Contacts

Public ContactAimin Wu

Wenzhou Medical University

aiminwu@163.com+86 f13758745616

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 26, 2026