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Application of 3D Printing Technology in Subtalar Arthrodesis

Primary Purpose

Ankle Injuries

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
3d printing personalized plate
Sponsored by
Southwest Hospital, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Ankle Injuries focused on measuring subtalar joint, arthrodesis, 3d printing

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Southwest HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

3D printing personalized plate

Arm Description

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

Outcomes

Primary Outcome Measures

Operation time
Operation time for internal fixation

Secondary Outcome Measures

Postoperative subtalar VAS score
Postoperative subtalar VAS score of the patients
Fusion rate
Fusion rate of the subtalar joint

Full Information

First Posted
May 5, 2017
Last Updated
November 18, 2018
Sponsor
Southwest Hospital, China
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1. Study Identification

Unique Protocol Identification Number
NCT03152916
Brief Title
Application of 3D Printing Technology in Subtalar Arthrodesis
Official Title
Application of 3D Printing Technology in Subtalar Arthrodesis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2014 (Actual)
Primary Completion Date
August 30, 2018 (Actual)
Study Completion Date
December 31, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southwest Hospital, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Injuries
Keywords
subtalar joint, arthrodesis, 3d printing

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
3D printing personalized plate
Arm Type
Experimental
Arm Description
3D printing personalized plate will be used to guide the Kirschner wires in the joint fusion surgery.
Intervention Type
Device
Intervention Name(s)
3d printing personalized plate
Intervention Description
3d printing personalized plate will be used in the subtalar arthrodensis
Primary Outcome Measure Information:
Title
Operation time
Description
Operation time for internal fixation
Time Frame
Intraoperative
Secondary Outcome Measure Information:
Title
Postoperative subtalar VAS score
Description
Postoperative subtalar VAS score of the patients
Time Frame
Postoperative 1,6,12 months
Title
Fusion rate
Description
Fusion rate of the subtalar joint
Time Frame
Postoperative 1,6,12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaojun Duan, MD
Phone
86-23-68765290
Email
duanxiaojun@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaojun Duan, MD
Organizational Affiliation
Southwest Hospital, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southwest Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaojun Duan, MD
Phone
86-23-68765290
Email
duanxiaojun@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33426066
Citation
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.
Results Reference
derived

Learn more about this trial

Application of 3D Printing Technology in Subtalar Arthrodesis

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