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

NCT ID: NCT03185286

Last Updated: 2017-06-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2019-12-31

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.

Conditions

Bone Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

3D-printed personalized metal implant

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

Group Type: EXPERIMENTAL

3d-printed personalized metal implant

Intervention Type: DEVICE

3d-printed personalized metal implant will be used in subtalar arthrodesis.

Interventions

3d-printed personalized metal implant

3d-printed personalized metal implant will be used in subtalar arthrodesis.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Southwest Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

Xiaojun Duan

Deputy Director of the Center for Joint Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiaojun Duan, MD

Role: PRINCIPAL_INVESTIGATOR

Southwest Hospital, China

Locations

Southwest Hospital

Chongqing, Chongqing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiaojun Duan, MD

Role: CONTACT

duanxiaojun@hotmail.com

86-23-68765290

Facility Contacts

Xiaojun Duan, MD

Role: primary

duanxiaojun@hotmail.com

86-23-68765290

Other Identifiers

3DIMPLANT

Identifier Type: -

Identifier Source: org_study_id