3D Printed Guide in Ankle Arthrodesis

Not Applicable

• Conditions: Ankle Injuries
• Interventions: Device: 3D-printed customized guide plate

• Registration Number: NCT03626935
• Lead Sponsor: Southwest Hospital, China

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.

Study Timeline

• Study Start: 2014-01-01
• Study First Submitted: 2018-08-08
• Study First Submitted QC: 2018-08-08
• Study First Posted: 2018-08-13
• Primary Completion: 2018-10-31
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-20
• Last Update Posted: 2019-03-22
• Study Completion: 2019-07-31

Recruitment & Eligibility

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
3D-printed customized guide plate	3D-printed customized guide plate	3D-printed customized guide plate will be used to guide the Kirschner wires in ankle arthrodesis.

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 ankle joint
Postoperative ankle AOFAS scale	Postoperative 1,6,12 months	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.

Trial Locations

Locations (1)

Southwest Hospital; 🇨🇳 Chongqing, Chongqing, China