- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03185286
3D-Printed Personalized Metal Implant in Surgical Treatment of Ankle Bone Defects
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Xiaojun Duan, MD
- Phone Number: 86-23-68765290
- Email: duanxiaojun@hotmail.com
Study Locations
-
-
Chongqing
-
Chongqing, Chongqing, China, 400030
- Recruiting
- Southwest Hospital
-
Contact:
- Xiaojun Duan, MD
- Phone Number: 86-23-68765290
- Email: duanxiaojun@hotmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 3D-printed personalized metal implant
3D-printed personalized metal implant will be used in bone defect surgeries.
|
3d-printed personalized metal implant will be used in subtalar arthrodesis.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analogue Scale (VAS)
Time Frame: Postoperative 24 months
|
The decrease in VAS score from baseline
|
Postoperative 24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
American Orthopedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Scale
Time Frame: Postoperative 24 months
|
The increase in AOFAS score from baseline
|
Postoperative 24 months
|
Lower limb alignment
Time Frame: Postoperative 24 months
|
Analyze the lower limb alignment by radiography
|
Postoperative 24 months
|
Osteotylus growth
Time Frame: Postoperative 24 months
|
Analyze the osteotylus growth by radiography
|
Postoperative 24 months
|
Implant displacement
Time Frame: Postoperative 24 months
|
Assess the implant displacement by radiography
|
Postoperative 24 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Xiaojun Duan, MD, Southwest Hospital, China
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3DIMPLANT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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