Clinical Application of Personal Designed 3D Printing Implants in Bone Defect Restoration

Not Applicable

• Conditions: Defect; Internal Prosthetic Device, Implants and Grafts, Orthopedic, Bone Graft

• Registration Number: NCT03166917
• Lead Sponsor: fang guofang

Brief Summary

Objective: Clinical application of 3D printing implant in bone defect treatment.

Study design: multicenter randomized controlled study . Methods:patients randomly grouped according to register number into internal fixation and bone graft group and 3D printing group. Reconstruct 3D models ,evaluate models preoperatively , simulate surgery in computer,design 3D implant, and 3D print implants,perform surgery with 3D implants to achieve the greatest degree of physiological reconstruction.Evaluate surgical efficacy .

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-05
• Study First Submitted: 2017-05-24
• Study First Submitted QC: 2017-05-24
• Last Update Submitted: 2017-05-24
• Study First Posted: 2017-05-25
• Last Update Posted: 2017-05-25
• Study Start: 2017-07-01
• Primary Completion: 2021-08-01
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Open fracture with bone defect
• Burst fracture of spine with bone defect
• Bone tumor with bone defect
• Bone tuberculosis with bone defect
• Nonunion with bone defect

Exclusion Criteria

• Patients who can not tolerate anesthesia and surgery due to severe impairment of heart and lung function
• Systemic or local infection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
operative time	3 years

Trial Locations

Locations (3)

Nanfang Hospital of Southern Medical University; 🇨🇳 Guangzhou, China

Zhujing hospital of southern medical university; 🇨🇳 Guanzhou, China

Shenzhen Hospital of Southern Medical University; 🇨🇳 Shenzhen, China