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

May 24, 2017 updated by: fang guofang

Shenzhen Hospital of Southern Medical University

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 .

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Guangzhou, China
        • Recruiting
        • Nanfang Hospital of Southern Medical University
        • Contact:
      • Guanzhou, China
        • Recruiting
        • Zhujing hospital of southern medical university
        • Contact:
      • Shenzhen, China
        • Recruiting
        • Shenzhen Hospital of Southern Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
operative time
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

fang guofang

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2017

Primary Completion (Anticipated)

August 1, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

May 24, 2017

First Submitted That Met QC Criteria

May 24, 2017

First Posted (Actual)

May 25, 2017

Study Record Updates

Last Update Posted (Actual)

May 25, 2017

Last Update Submitted That Met QC Criteria

May 24, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • C1033429

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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