Clinical Trials/NCT03166917

NCT03166917

Unknown

Not Applicable

Shenzhen Hospital of Southern Medical University

fang guofang3 sites in 1 country300 target enrollmentJuly 1, 2017

ConditionsDefect; Internal Prosthetic Device, Implants and Grafts, Orthopedic, Bone Graft

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Defect; Internal Prosthetic Device, Implants and Grafts, Orthopedic, Bone Graft
Sponsor: fang guofang
Enrollment: 300
Locations: 3
Primary Endpoint: operative time
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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 .

Registry

clinicaltrials.gov

Start Date

July 1, 2017

End Date

December 31, 2021

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

fang guofang

Responsible Party

Sponsor Investigator

Principal Investigator

fang guofang

Shenzhen Hospital of Southern Medical University

Shenzhen Hospital of Southern Medical University

Eligibility Criteria

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

Outcomes

Primary Outcomes

operative time

Time Frame: 3 years

Study Sites (3)

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