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

Bone Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03185286
• Other study ID #: 3DIMPLANT
• Status: Recruiting
• Phase: N/A
• First received: June 9, 2017
• Last updated: June 12, 2017
• Start date: December 31, 2015
• Est. completion date: December 31, 2019

Study information

• Verified date: June 2017
• Source: Southwest Hospital, China
• Contact: Xiaojun Duan, MD
• Phone: 86-23-68765290
• Email: duanxiaojun[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bone Diseases

Intervention

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

Locations

Country	Name	City	State
China	Southwest Hospital	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Southwest Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogue Scale (VAS)	The decrease in VAS score from baseline	Postoperative 24 months
Secondary	American Orthopedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Scale	The increase in AOFAS score from baseline	Postoperative 24 months
Secondary	Lower limb alignment	Analyze the lower limb alignment by radiography	Postoperative 24 months
Secondary	Osteotylus growth	Analyze the osteotylus growth by radiography	Postoperative 24 months
Secondary	Implant displacement	Assess the implant displacement by radiography	Postoperative 24 months