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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

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

Clinicaltrials.gov identifier NCT03941028

Recruitment Status Recruiting

First Posted May 7, 2019

Last update posted May 7, 2019

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:Large Segmental Bone Defect
  • Intervention/Treatment: Device: 3D printed titanium implant
  • Phase: N/A
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
  • Study Type: Interventional
  • 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 2019
  • Estimated Primary Completion Date: June 2021
  • Estimated Study Completion Date: December 2021
Arms and interventions
Arm Intervention/treatment
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 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 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
  • 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

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

Locations

China, Beijing
Peking University Third Hospital
Beijing

Sponsors and Collaborators

Peking University Third Hospital

Investigators

Principal Investigator: Yun Tian, MD Peking University Third Hospital

More Information
  • Responsible Party: Peking University Third Hospital
  • ClinicalTrials.gov Identifier: NCT03941028 History of Changes
  • Other Study ID Numbers: Z181100001718195
  • First Posted: May 7, 2019 Key Record Dates
  • Last Update Posted: May 7, 2019
  • Last Verified: April 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No