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

Not Applicable

• Conditions: Bone Diseases

• Registration Number: NCT03185286
• Lead Sponsor: Southwest Hospital, China

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.

Study Timeline

• Study Start: 2015-12-31
• Status Verified: 2017-06
• Study First Submitted: 2017-06-09
• Study First Submitted QC: 2017-06-12
• Last Update Submitted: 2017-06-12
• Study First Posted: 2017-06-14
• Last Update Posted: 2017-06-14
• Primary Completion: 2018-12-31
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale (VAS)	Postoperative 24 months	The decrease in VAS score from baseline

Secondary Outcome Measures

Name	Time	Method
Osteotylus growth	Postoperative 24 months	Analyze the osteotylus growth by radiography
Implant displacement	Postoperative 24 months	Assess the implant displacement by radiography
Lower limb alignment	Postoperative 24 months	Analyze the lower limb alignment by radiography
American Orthopedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Scale	Postoperative 24 months	The increase in AOFAS score from baseline

Trial Locations

Locations (1)

Southwest Hospital; 🇨🇳 Chongqing, Chongqing, China