Application of 3D Printing Technology in Subtalar Arthrodesis

NCT ID: NCT03152916

Last Updated: 2018-11-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-01
• Study Completion Date: 2018-12-31

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.

Conditions

Ankle Injuries

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

3D printing personalized plate

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

Group Type: EXPERIMENTAL

3d printing personalized plate

Intervention Type: DEVICE

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

Interventions

3d printing personalized plate

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Southwest Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

Xiaojun Duan

Deputy Director of the Center for Joint Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiaojun Duan, MD

Role: PRINCIPAL_INVESTIGATOR

Southwest Hospital, China

Locations

Southwest Hospital

Chongqing, Chongqing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiaojun Duan, MD

Role: CONTACT

duanxiaojun@hotmail.com

86-23-68765290

Facility Contacts

Xiaojun Duan, MD

Role: primary

duanxiaojun@hotmail.com

86-23-68765290

References

Zhang C, Cao J, Zhu H, Fan H, Yang L, Duan X. Endoscopic Treatment of Symptomatic Foot and Ankle Bone Cyst with 3D Printing Application. Biomed Res Int. 2020 Dec 26;2020:8323658. doi: 10.1155/2020/8323658. eCollection 2020.

Reference Type: DERIVED

PMID: 33426066 (View on PubMed)

Other Identifiers

CfJSSouthwestH

Identifier Type: -

Identifier Source: org_study_id