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

• Sponsor: Southwest Hospital, China (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03185286
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 48
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Bone Diseases	Device: 3d-printed personalized metal implant	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 3D-Printed Personalized Metal Implant in Surgical Treatment of Ankle Bone Defects
• Actual Study Start Date: Dec 31, 2015
• Anticipated Primary Completion Date: Dec 31, 2018
• Anticipated Study Completion Date: Dec 31, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Visual Analogue Scale (VAS) [Postoperative 24 months]

   The decrease in VAS score from baseline

Secondary Outcome Measures

1. American Orthopedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Scale [Postoperative 24 months]

   The increase in AOFAS score from baseline

2. Lower limb alignment [Postoperative 24 months]

   Analyze the lower limb alignment by radiography

3. Osteotylus growth [Postoperative 24 months]

   Analyze the osteotylus growth by radiography

4. Implant displacement [Postoperative 24 months]

   Assess the implant displacement by radiography

Eligibility Criteria

Criteria

• Ages Eligible for Study: 14 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Southwest Hospital	Chongqing	Chongqing	China	400030

Sponsors and Collaborators

• Southwest Hospital, China

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Xiaojun Duan, Deputy Director of the Center for Joint Surgery, Southwest Hospital, China
• ClinicalTrials.gov Identifier: NCT03185286
• Other Study ID Numbers: 3DIMPLANT
• First Posted: Jun 14, 2017
• Last Update Posted: Jun 14, 2017
• Last Verified: Jun 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Xiaojun Duan, Deputy Director of the Center for Joint Surgery, Southwest Hospital, China: 3D printing, metal implant, bone defect
• Additional relevant MeSH terms: Bone Diseases

Study Results

No Results Posted as of Jun 14, 2017