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

fang guofang

Status: Unknown

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

Treatments: Procedure: 3D printing implant; Procedure: autogenous bone grafting

Study type: Interventional

Funder types: Other

Identifiers

NCT03166917

C1033429

Details and patient eligibility

About

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 .

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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300 participants in 2 patient groups, including a placebo group

3D printing implant

Experimental group

Description:

3D printing implant in bone defect

Treatment:

Procedure: 3D printing implant

Autogenous bone grafting

Placebo Comparator group

Description:

autogenous bone grafting in bone defect

Treatment:

Procedure: autogenous bone grafting