3D Printed Guide in Ankle Arthrodesis

Ankle Injuries Clinical Trial

Official title:

3D Printed Customized Guide in Ankle Arthrodesis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03626935
• Other study ID #: 3DAnkleGuide
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2014
• Est. completion date: July 31, 2019

Study information

• Verified date: March 2019
• Source: Southwest Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: July 31, 2019
• Est. primary completion date: October 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ankle Injuries

Intervention

Device:
• 3D-printed customized guide plate
3D-printed customized guide plate will be used in the ankle arthrodesis to help reduce operation time and reduce intra-operative radiation.

Locations

Country	Name	City	State
China	Southwest Hospital	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Southwest Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operation time	Operation time for internal fixation	Intraoperative
Secondary	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
Secondary	Fusion rate	Fusion rate of the ankle joint	Postoperative 1,6,12 months