3D Printed Guide in Ankle Arthrodesis

NCT ID: NCT03626935

Last Updated: 2019-03-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-01
• Study Completion Date: 2019-07-31

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.

Conditions

Ankle Injuries

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

3D-printed customized guide plate

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

Group Type: EXPERIMENTAL

3D-printed customized guide plate

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Southwest Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

Xiaojun Duan

Deputy Director of the Center for Joint Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiaojun Duan, M.D.

Role: PRINCIPAL_INVESTIGATOR

Southwest Hospital, China

Locations

Southwest Hospital

Chongqing, Chongqing Municipality, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 30276205 (View on PubMed)

Other Identifiers

3DAnkleGuide

Identifier Type: -

Identifier Source: org_study_id