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

Army Medical University

Status: Unknown

Conditions: Bone Diseases

Treatments: Device: 3d-printed personalized metal implant

Study type: Interventional

Funder types: Other

Identifiers

NCT03185286

3DIMPLANT

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 14+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

3D-printed personalized metal implant

Experimental group

Description:

3D-printed personalized metal implant will be used in bone defect surgeries.

Treatment:

Device: 3d-printed personalized metal implant