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出境医 / 临床实验 / Clinical Effects of Large Segmental Bone Defects With 3D Printed Titanium Implant

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

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Large Segmental Bone Defect Device: 3D printed titanium implant Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Effects of Large Segmental Bone Defects Caused by Trauma, Infection and Tumor With 3D Printed Titanium Implant
Actual Study Start Date : January 12, 2019
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : December 30, 2021
Arms and Interventions
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.
Outcome Measures
Primary Outcome Measures :
  1. Bone reconstruction [ Time Frame: 1 year ]
    X-rays and CT scans are used to evaluate the bone reconstruction


Secondary Outcome Measures :
  1. Questionnaire of limb function [ Time Frame: 1 year ]
    Restoration of limb function.


Other Outcome Measures:
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Contacts
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Contact: Bingchuan Liu, MD +86-18310188678 liubc@bjmu.edu.cn

Locations
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China, Beijing
Peking University Third Hospital Recruiting
Beijing, Beijing, China, 100191
Contact: Yun Tian, MD    +8610-82267010    tiany@bjmu.edu.cn   
Sponsors and Collaborators
Peking University Third Hospital
Investigators
Layout table for investigator information
Principal Investigator: Yun Tian, MD Peking University Third Hospital
Tracking Information
First Submitted Date  ICMJE April 15, 2019
First Posted Date  ICMJE May 7, 2019
Last Update Posted Date May 7, 2019
Actual Study Start Date  ICMJE January 12, 2019
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 5, 2019) 		Bone reconstruction [ Time Frame: 1 year ]
X-rays and CT scans are used to evaluate the bone reconstruction
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 5, 2019) 		Questionnaire of limb function [ Time Frame: 1 year ]
Restoration of limb function.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 5, 2019) 		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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Clinical Effects of Large Segmental Bone Defects With 3D Printed Titanium Implant
Official Title  ICMJE Clinical Effects of Large Segmental Bone Defects Caused by Trauma, Infection and Tumor With 3D Printed Titanium Implant
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Large Segmental Bone Defect
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: bone defects caused by trauma
    Large bone defects (>6cm) caused by trauma
    Intervention: Device: 3D printed titanium implant
  • Experimental: bone defects caused by infection
    Large bone defects caused by chronic osteomyelitis
    Intervention: Device: 3D printed titanium implant
  • Experimental: bone defects caused by tumor
    Large bone defects caused by benign tumor
    Intervention: Device: 3D printed titanium implant
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 5, 2019) 		20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2021
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Bingchuan Liu, MD +86-18310188678 liubc@bjmu.edu.cn
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03941028
Other Study ID Numbers  ICMJE Z181100001718195
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Peking University Third Hospital
Study Sponsor  ICMJE Peking University Third Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yun Tian, MD Peking University Third Hospital
PRS Account Peking University Third Hospital
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP