3D-Printed Personalized Metal Implant in Surgical Treatment of Ankle Bone Defects
Primary Purpose
Bone Diseases
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
3d-printed personalized metal implant
Sponsored by
About this trial
This is an interventional treatment trial for Bone Diseases focused on measuring 3D printing, metal implant, bone defect
Eligibility Criteria
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.
Sites / Locations
- Southwest HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
3D-printed personalized metal implant
Arm Description
3D-printed personalized metal implant will be used in bone defect surgeries.
Outcomes
Primary Outcome Measures
Visual Analogue Scale (VAS)
The decrease in VAS score from baseline
Secondary Outcome Measures
American Orthopedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Scale
The increase in AOFAS score from baseline
Lower limb alignment
Analyze the lower limb alignment by radiography
Osteotylus growth
Analyze the osteotylus growth by radiography
Implant displacement
Assess the implant displacement by radiography
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03185286
Brief Title
3D-Printed Personalized Metal Implant in Surgical Treatment of Ankle Bone Defects
Official Title
3D-Printed Personalized Metal Implant in Surgical Treatment of Ankle Bone Defects
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 31, 2015 (Actual)
Primary Completion Date
December 31, 2018 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southwest Hospital, China
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study aims to use 3D-printed personalized metal implants for bone defect surgeries in order to reduce pain of the patients.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Diseases
Keywords
3D printing, metal implant, bone defect
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
3D-printed personalized metal implant
Arm Type
Experimental
Arm Description
3D-printed personalized metal implant will be used in bone defect surgeries.
Intervention Type
Device
Intervention Name(s)
3d-printed personalized metal implant
Intervention Description
3d-printed personalized metal implant will be used in subtalar arthrodesis.
Primary Outcome Measure Information:
Title
Visual Analogue Scale (VAS)
Description
The decrease in VAS score from baseline
Time Frame
Postoperative 24 months
Secondary Outcome Measure Information:
Title
American Orthopedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Scale
Description
The increase in AOFAS score from baseline
Time Frame
Postoperative 24 months
Title
Lower limb alignment
Description
Analyze the lower limb alignment by radiography
Time Frame
Postoperative 24 months
Title
Osteotylus growth
Description
Analyze the osteotylus growth by radiography
Time Frame
Postoperative 24 months
Title
Implant displacement
Description
Assess the implant displacement by radiography
Time Frame
Postoperative 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaojun Duan, MD
Phone
86-23-68765290
Email
duanxiaojun@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaojun Duan, MD
Organizational Affiliation
Southwest Hospital, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southwest Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaojun Duan, MD
Phone
86-23-68765290
Email
duanxiaojun@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
3D-Printed Personalized Metal Implant in Surgical Treatment of Ankle Bone Defects
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