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Clinical study for 3D printed guiding device assisted bilateral crossing cervical microendoscopic laminoplasty for cervical spondylotic myelopathy

3D printed guiding device assisted bilateral crossing cervical microendoscopic laminoplasty for cervical spondylotic myelopathy: a study protocol for single-centre randomised controlled trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900023100
Enrollment
Unknown
Registered
2019-05-11
Start date
2019-06-01
Completion date
Unknown
Last updated
2019-05-13

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

Conditions

Cervical spondylotic myelopathy

Interventions

Experimental group:3D printed guiding device assisted bilateral crossing cervical microendoscopic laminoplasty
Control group:Cervical microendoscopic laminoplasty

Sponsors

The First Affiliated Hospital of Zhengzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged > 16 years; 2. 2 to 5 levels of cervical degenerative disc disease or spinal canal stenosis at C3-C7; 3. Diagnosis of degenerative disc disease or spinal canal stenosis verified by medical history and physical examination; 4. MRI and CT showed that the canal/vertebral body sagittal ratio was less than 0.75, but no focal protrusion, fragment protrusion or nerve root compression; 5. Strict conservative treatment was ineffective for more than 3 months.

Exclusion criteria

Exclusion criteria: 1. Single-level spinal canal stenosis or degenerative disc disease; 2. Cervical spondylotic radiculopathy, radiological evidence of nerve root compression caused by disc herniation; 3. Severe osteoporosis; 4. Greater than grade 1 spondylolisthesis; 5. Unwilling to sign informed consent for the study.

Design outcomes

Primary

MeasureTime frame
Incision length;Operative time;Intraoperative blood loss;Adverse events;

Secondary

MeasureTime frame
The Japanese Orthopedic Association (JOA) score;The visual analogue scales (VAS);Cervical curvature index;Range of motion;The sagittal diameter of the spinal canal;The healing of the grooves;

Countries

China

Contacts

Public ContactChunlin Zhang

The First Affiliated Hospital of Zhengzhou University

zzclin@126.com+86 13903835325

Outcome results

None listed

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