Clinical Effects of Large Segmental Bone Defects With 3D Printed Titanium Implant

May 5, 2019 updated by: Peking University Third Hospital

Clinical Effects of Large Segmental Bone Defects Caused by Trauma, Infection and Tumor With 3D Printed Titanium Implant

The investigators apply 3D printed titanium implant to treat bone defects. Without using bone grafts and growth factors, the investigators anticipate the titanium implant alone can help bone reconstruction.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The investigators treat large segmental bone defects caused by three reasons, including trauma, infection and tumor. In this study, polyporous 3D printed titanium implant is applied to reconstruct the bone defects and the investigators will follow up patients' function and bone regeneration.

Study Type

Interventional

Enrollment (Anticipated)

20

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
    • Beijing
      • Beijing, Beijing, China, 100191
        • Recruiting
        • Peking University Third Hospital
        • 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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • bone defects caused by trauma or infection or tumor
  • the length of bone defect is more than 6cm
  • more than 18 years old

Exclusion Criteria:

  • malignant tumor
  • patients with bad conditions failing to tolerate surgery

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: bone defects caused by trauma
Large bone defects (>6cm) caused by trauma
Device: 3D printed titanium implant
The 3D printed titanium implant is fabricated by related companies. And some implants have been used in spinal disease in our hospital.
Experimental: bone defects caused by infection
Large bone defects caused by chronic osteomyelitis
Device: 3D printed titanium implant
The 3D printed titanium implant is fabricated by related companies. And some implants have been used in spinal disease in our hospital.
Experimental: bone defects caused by tumor
Large bone defects caused by benign tumor
Device: 3D printed titanium implant
The 3D printed titanium implant is fabricated by related companies. And some implants have been used in spinal disease in our hospital.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone reconstruction
Time Frame: 1 year
X-rays and CT scans are used to evaluate the bone reconstruction
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Questionnaire of limb function
Time Frame: 1 year
Restoration of limb function.
1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Questionnaire of patients' satisfaction degree
Time Frame: 1 year
VAS score is used to evaluate the satisfaction degree. The score ranges from 0 to 10, 0 means very dissatisfied and 10 means very satisfied.
1 year

Collaborators and Investigators

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

Sponsor

Peking University Third Hospital

Investigators

  • Principal Investigator: Yun Tian, MD, Peking University Third Hospital

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 (Actual)

January 12, 2019

Primary Completion (Anticipated)

June 30, 2021

Study Completion (Anticipated)

December 30, 2021

Study Registration Dates

First Submitted

April 15, 2019

First Submitted That Met QC Criteria

May 5, 2019

First Posted (Actual)

May 7, 2019

Study Record Updates

Last Update Posted (Actual)

May 7, 2019

Last Update Submitted That Met QC Criteria

May 5, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • Z181100001718195

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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