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A non randomized controlled study of 3D printing artificial vertebral body in the treatment of spinal tumors

A non randomized controlled study of 3D printing artificial vertebral body in the treatment of spinal tumors

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000038145
Enrollment
Unknown
Registered
2020-09-11
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-11-30

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

Conditions

Spinal Tumor

Interventions

experimental group :Vertebral excision and 3D printed artificial vertebral reconstruction
control group:Vertebral body resection and titanium cage reconstruction

Sponsors

Zhongnan Hospital Of Wuhan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Subjects who met all the following conditions were enrolled in the study 1. Primary or metastatic spinal malignant tumor diagnosed clinically; 2. Preoperative Tomita score was 1-5; 3. The patient is in good health and can accept tumor resection surgery; 4. Understand and follow the research process, participate voluntarily and sign the informed consent form.

Exclusion criteria

Exclusion criteria: Subjects who meet one of the following conditions will not be enrolled in this study: 1. Patients with advanced malignant tumors with multiple metastases; 2. Patients who do not accept or cannot understand the purpose of treatment; 3. Patients with other medical diseases who cannot tolerate the operation as assessed by the department of anesthesiology; 4. Persons with incomplete capacity for civil conduct; 5. The investigator task is not suitable for the subjects participating in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Whether the implant is loose or sink;The degree of fusion between artificial prosthesis and adjacent vertebral bodies at different time points;Operation time;estimated blood loss;ASIA spinal cord injury classification;ECOG score standard;VAS;

Secondary

MeasureTime frame
clinical symptoms;Quality of life;

Countries

China

Contacts

Public ContactLin Cai

Zhongnan Hospital of Wuhan University

orthopedics@whu.edu.cn+86 13886096467

Outcome results

None listed

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