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

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ClinicalTrials.gov Identifier: NCT03166917
Recruitment Status : Recruiting
First Posted : May 25, 2017
Last Update Posted : May 25, 2017
Sponsor:
Information provided by (Responsible Party):
fang guofang, Shenzhen Hospital of Southern Medical University

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 .


Condition or disease Intervention/treatment Phase
Defect; Internal Prosthetic Device, Implants and Grafts, Orthopedic, Bone Graft Procedure: 3D printing implant Procedure: autogenous bone grafting Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Shenzhen Hospital of Southern Medical University
Estimated Study Start Date : July 1, 2017
Estimated Primary Completion Date : August 1, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Grafts

Arm Intervention/treatment
Experimental: 3D printing implant
3D printing implant in bone defect
Procedure: 3D printing implant
3D printing implants in bone defect

Placebo Comparator: Autogenous bone grafting
autogenous bone grafting in bone defect
Procedure: autogenous bone grafting
3D printing implants in bone defect




Primary Outcome Measures :
  1. operative time [ Time Frame: 3 years ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03166917


Locations
China
Nanfang Hospital of Southern Medical University Recruiting
Guangzhou, China
Contact: gang wang, doctor    13902989637    13902989637@139.com   
Zhujing hospital of southern medical university Recruiting
Guanzhou, China
Contact: lixin Zhu, doctor    13926114760    13926114760@139.com   
Shenzhen Hospital of Southern Medical University Recruiting
Shenzhen, China
Contact: guofang fang, doctor    18820153828    fanguofan@163.com   
Sponsors and Collaborators
fang guofang

Publications:
Responsible Party: fang guofang, Shenzhen Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT03166917     History of Changes
Other Study ID Numbers: C1033429
First Posted: May 25, 2017    Key Record Dates
Last Update Posted: May 25, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No