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

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

Study Overview

• Status: Unknown
• Conditions: Bone Diseases
• Intervention / Treatment: Device: 3d-printed personalized metal implant

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiaojun Duan, MD; Phone Number: 86-23-68765290; Email: duanxiaojun@hotmail.com

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400030
      • Recruiting
      • Southwest Hospital
      • Contact: Xiaojun Duan, MD; Phone Number: 86-23-68765290; Email: duanxiaojun@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Southwest Hospital, China
• Investigators: Principal Investigator: Xiaojun Duan, MD, Southwest Hospital, China

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2015
• Primary Completion (Anticipated): December 31, 2018
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: June 9, 2017
• First Submitted That Met QC Criteria: June 12, 2017
• First Posted (Actual): June 14, 2017

Study Record Updates

• Last Update Posted (Actual): June 14, 2017
• Last Update Submitted That Met QC Criteria: June 12, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: 3D printing, metal implant, bone defect
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases
• Other Study ID Numbers: 3DIMPLANT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No