Application of 3D Printing Technology in Subtalar Arthrodesis

Not Applicable

• Conditions: Ankle Injuries
• Interventions: Device: 3d printing personalized plate

• Registration Number: NCT03152916
• Lead Sponsor: Southwest Hospital, China

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2014-01-01
• Study First Submitted: 2017-05-05
• Study First Submitted QC: 2017-05-12
• Study First Posted: 2017-05-15
• Primary Completion: 2018-08-30
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-18
• Last Update Posted: 2018-11-20
• Study Completion: 2018-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
3D printing personalized plate	3d printing personalized plate	3D printing personalized plate will be used to guide the Kirschner wires in the joint fusion surgery.

Primary Outcome Measures

Name	Time	Method
Operation time	Intraoperative	Operation time for internal fixation

Secondary Outcome Measures

Name	Time	Method
Fusion rate	Postoperative 1,6,12 months	Fusion rate of the subtalar joint
Postoperative subtalar VAS score	Postoperative 1,6,12 months	Postoperative subtalar VAS score of the patients

Trial Locations

Locations (1)

Southwest Hospital; 🇨🇳 Chongqing, Chongqing, China