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3D-Printed Personalized Metal Implant in Surgical Treatment of Ankle Bone Defects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03185286
Recruitment Status : Recruiting
First Posted : June 14, 2017
Last Update Posted : June 14, 2017
Information provided by (Responsible Party):
Xiaojun Duan, Southwest Hospital, China

Brief Summary:
This study aims to use 3D-printed personalized metal implants for bone defect surgeries in order to reduce pain of the patients.

Condition or disease Intervention/treatment Phase
Bone Diseases Device: 3d-printed personalized metal implant Not Applicable

Detailed Description:

Bone defects are common in ankle disease, and the conventional treatment includes autologous or allogeneic bone grafts. However, autologous bone graft may cause complications and its source is rather limited; allogeneic bone graft may cause disease transmission and the mechanical strength of the graft is low after processing.

The 3D printing technology has provided a new way of solving this problem. It has the following technical advantages: wide range of graft sources, high mechanical strength, and can be prepared in advance according to various shapes.

Preparation procedure: first, establish the individualized ankle model according to the patient's ankle CT scan data and then prepare the implant model; second, conduct surgery rehearsal and place the implant model in the ankle model for observation; third, after confirmation, use titanium alloy in the 3D printing machine to prepare the individualized metal implant, which is in line with the Chinese National Standard "Wrought titanium and titanium alloy for surgical implants" (GB/T 13810-2007); fourth, implant the individualized metal implant into the bone defect area after sterilization.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 3D-Printed Personalized Metal Implant in Surgical Treatment of Ankle Bone Defects
Actual Study Start Date : December 31, 2015
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Diseases

Arm Intervention/treatment
Experimental: 3D-printed personalized metal implant
3D-printed personalized metal implant will be used in bone defect surgeries.
Device: 3d-printed personalized metal implant
3d-printed personalized metal implant will be used in subtalar arthrodesis.

Primary Outcome Measures :
  1. Visual Analogue Scale (VAS) [ Time Frame: Postoperative 24 months ]
    The decrease in VAS score from baseline

Secondary Outcome Measures :
  1. American Orthopedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Scale [ Time Frame: Postoperative 24 months ]
    The increase in AOFAS score from baseline

  2. Lower limb alignment [ Time Frame: Postoperative 24 months ]
    Analyze the lower limb alignment by radiography

  3. Osteotylus growth [ Time Frame: Postoperative 24 months ]
    Analyze the osteotylus growth by radiography

  4. Implant displacement [ Time Frame: Postoperative 24 months ]
    Assess the implant displacement by radiography

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Receive ankle or subtalar arthrodesis;
  • Refuse to use autologous bone graft or allogeneic bone graft.

Exclusion Criteria:

  • The local defect area is small;
  • Refuse to use permanent metal metal implant.

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 identifier (NCT number): NCT03185286

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Contact: Xiaojun Duan, MD 86-23-68765290

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China, Chongqing
Southwest Hospital Recruiting
Chongqing, Chongqing, China, 400030
Contact: Xiaojun Duan, MD    86-23-68765290   
Sponsors and Collaborators
Southwest Hospital, China
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Principal Investigator: Xiaojun Duan, MD Southwest Hospital, China

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Responsible Party: Xiaojun Duan, Deputy Director of the Center for Joint Surgery, Southwest Hospital, China Identifier: NCT03185286     History of Changes
Other Study ID Numbers: 3DIMPLANT
First Posted: June 14, 2017    Key Record Dates
Last Update Posted: June 14, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Xiaojun Duan, Southwest Hospital, China:
3D printing, metal implant, bone defect

Additional relevant MeSH terms:
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Bone Diseases
Musculoskeletal Diseases