3D Printed Guide in Ankle Arthrodesis
Primary Purpose
Ankle Injuries
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
3D-printed customized guide plate
Sponsored by
About this trial
This is an interventional device feasibility trial for Ankle Injuries focused on measuring ankle joint, arthrodesis, 3d printing, customized guide
Eligibility Criteria
Inclusion Criteria:
- Patients who receive ankle arthrodesis and consider internal fixation with screws
Exclusion Criteria:
- Patients who receive ankle arthrodesis but do not consider internal fixation with screws
Sites / Locations
- Southwest Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
3D-printed customized guide plate
Arm Description
3D-printed customized guide plate will be used to guide the Kirschner wires in ankle arthrodesis.
Outcomes
Primary Outcome Measures
Operation time
Operation time for internal fixation
Secondary Outcome Measures
Postoperative ankle AOFAS scale
Postoperative American Orthopaedic Foot and Ankle Society (AOFAS) Scale of the ankle joint. Scale range: 0-100 points. Outcome evaluation: Excellent, 90-100; Good, 75-89; Average, 50-74;Poor, <50.
Fusion rate
Fusion rate of the ankle joint
Full Information
NCT ID
NCT03626935
First Posted
August 8, 2018
Last Updated
March 20, 2019
Sponsor
Southwest Hospital, China
1. Study Identification
Unique Protocol Identification Number
NCT03626935
Brief Title
3D Printed Guide in Ankle Arthrodesis
Official Title
3D Printed Customized Guide in Ankle Arthrodesis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2014 (Actual)
Primary Completion Date
October 31, 2018 (Actual)
Study Completion Date
July 31, 2019 (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 applies 3D-printed customized guide plate in assisting the accurate drilling of Kirschner wire in ankle arthrodesis. This technique can shorten the operation time, reduce the intra-operative radiation, and do not affect the surgical outcome.
Detailed Description
Ankle arthrodesis is the standard procedure for treating end-stage joint diseases. In order to improve the surgical outcome and reduce the operation time, 3D-printed customized guide plates are fabricated using patients' ankle DICM data of ankle via CT examinations. Two 2mm Kirschner wires are drilled with the help of the guides; the C-arm fluoroscopy is used to confirm the position of the wires before applying the cannulated screws for effective fixation.
In the past when there were no customized guides, the surgeons would drill the Kirschner wire according to his/her previous experience and then use C-arm fluoroscopy to confirm whether the position of the wire is satisfactory; if not, repeated procedure will be performed. This would lead to an increase in the duration of surgery and intra-operative radiation, which is detrimental to both the surgeon and the patient. This problem is well solved by applying the 3D-printed customized guides.
The application procedure for the customized guide plates: the model of the ankle joint is established according to the patient's CT scan data to prepare the customized guide plate, then sterilize them for future use. Apply routine surgical treatment to the ankle joint surface, reset the fusion joint to the functional position, and drill two 2mm Kirschner wires with the guidance of the guide plate. If the locations of the fusion joint and the Kirschner wires are satisfactory under the C-arm fluoroscopy, drill the cannulated screws 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
ankle joint, arthrodesis, 3d printing, customized guide
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-printed customized guide plate
Arm Type
Experimental
Arm Description
3D-printed customized guide plate will be used to guide the Kirschner wires in ankle arthrodesis.
Intervention Type
Device
Intervention Name(s)
3D-printed customized guide plate
Intervention Description
3D-printed customized guide plate will be used in the ankle arthrodesis to help reduce operation time and reduce intra-operative radiation.
Primary Outcome Measure Information:
Title
Operation time
Description
Operation time for internal fixation
Time Frame
Intraoperative
Secondary Outcome Measure Information:
Title
Postoperative ankle AOFAS scale
Description
Postoperative American Orthopaedic Foot and Ankle Society (AOFAS) Scale of the ankle joint. Scale range: 0-100 points. Outcome evaluation: Excellent, 90-100; Good, 75-89; Average, 50-74;Poor, <50.
Time Frame
Postoperative 1,6,12 months
Title
Fusion rate
Description
Fusion rate of the ankle 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 ankle arthrodesis and consider internal fixation with screws
Exclusion Criteria:
Patients who receive ankle arthrodesis but do not consider internal fixation with screws
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaojun Duan, M.D.
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
12. IPD Sharing Statement
Citations:
PubMed Identifier
30276205
Citation
Duan X, He P, Fan H, Zhang C, Wang F, Yang L. Application of 3D-Printed Personalized Guide in Arthroscopic Ankle Arthrodesis. Biomed Res Int. 2018 Sep 12;2018:3531293. doi: 10.1155/2018/3531293. eCollection 2018.
Results Reference
derived
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3D Printed Guide in Ankle Arthrodesis
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