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

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

Detailed Description
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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.

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

Conditions
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Bone Diseases

Intervention / Treatment
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* Device: 3d-printed personalized metal implant


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3D-printed personalized metal implant<br>3D-printed personalized metal implant will be used in bone defect surgeries. | Device: 3d-printed personalized metal implant<br>* 3d-printed personalized metal implant will be used in subtalar arthrodesis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale (VAS) | 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 | The increase in AOFAS score from baseline | Postoperative 24 months | 
| Lower limb alignment | Analyze the lower limb alignment by radiography | Postoperative 24 months | 
| Osteotylus growth | Analyze the osteotylus growth by radiography | Postoperative 24 months | 
| Implant displacement | Assess the implant displacement by radiography | Postoperative 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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3D printing, metal implant, bone defect