3D Printed Guide in Ankle Arthrodesis

Study Overview
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Brief Summary
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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
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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.

Official Title
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3D Printed Customized Guide in Ankle Arthrodesis

Conditions
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Ankle Injuries

Intervention / Treatment
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* Device: 3D-printed customized guide plate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3D-printed customized guide plate<br>3D-printed customized guide plate will be used to guide the Kirschner wires in ankle arthrodesis. | Device: 3D-printed customized guide plate<br>* 3D-printed customized guide plate will be used in the ankle arthrodesis to help reduce operation time and reduce intra-operative radiation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operation time | Operation time for internal fixation | Intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Postoperative 1,6,12 months | 
| Fusion rate | Fusion rate of the ankle joint | Postoperative 1,6,12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ankle joint, arthrodesis, 3d printing, customized guide