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NCT03152916 Clinical Trial

Application of 3D Printing Technology in Subtalar Arthrodesis

Ankle Injuries Clinical Trial

Official title:
Application of 3D Printing Technology in Subtalar Arthrodesis

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03152916
Other study ID # CfJSSouthwestH
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2014
Est. completion date December 31, 2018

Study information
Verified date November 2018
Source Southwest Hospital, China
Contact Xiaojun Duan, MD
Phone 86-23-68765290
Email duanxiaojun@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to use 3D printing personalized plate to locate the position in which the K-wires would be drilled to save operation time and decrease the number of times that the K-wires are drilled.

Description:

Subtalar arthrodesis is a standard procedure for treating joint injuries in terminal stage. In this study, in order to improve efficacy and shorten the operation time, personalized plate is prepared before surgery. During the surgery, the articular cartilage is scraped, then the fusion joint is reset to the functional position; the 2-2mm Kirschner wires are drilled with the assistance of the personalized plate,then the position of the fusion joint as well as the Kirschner wires are confirmed under the C-arm; lastly, cannulated screws are screwed in along the Kirschner wires for effective fixation.

In the past surgeries without personalized plate, surgeons could only rely on their experience to locate the position for drilling and then confirm under the C-arm. This would prolong the operation time and be more traumatic to the patients. Using 3D printing personalized plate can solve this problem.

The preparation procedure for the personalized plate: firstly, ankle model are established according to the patient's CT scan data, then select modular pieces to prepare the personalized plate, sterilize it for future use. Apply conventional surgical treatment to the subtalar surface, reset the fusion joint to the functional position, and drill 2-2mm Kirschner wires with the guidance of the plate. If the locations of the fusion joint and the Kirschner wires are satisfying under the C-arm inspection, drill the hollow screw for final fixation.

Recruitment information / eligibility
Status Recruiting
Enrollment 10
Est. completion date December 31, 2018
Est. primary completion date August 30, 2018
Accepts healthy volunteers No
Gender All
Age group 14 Years and older
Eligibility Inclusion Criteria:

- Patients who receive subtalar arthrodesis and consider internal fixation with screws

Exclusion Criteria:

- Patients who receive subtalar arthrodesis but do not consider internal fixation with screws

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• 3d printing personalized plate
3d printing personalized plate will be used in the subtalar arthrodensis

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 Operation time Operation time for internal fixation Intraoperative
Secondary Postoperative subtalar VAS score Postoperative subtalar VAS score of the patients Postoperative 1,6,12 months
Secondary Fusion rate Fusion rate of the subtalar joint Postoperative 1,6,12 months
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