Clinical trial NCT03626935: 3D Printed Guide in Ankle Arthrodesis
Official title: 3D Printed Customized Guide in Ankle Arthrodesis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ankle Injuries
Keywords: ankle joint
arthrodesis
3d printing
customized guide
Lead sponsor: Southwest Hospital, China
Sponsor class: OTHER
First posted: 2018-08-13
Enrollment: 10
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.

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

Primary outcomes:
measure: Operation time
timeFrame: Intraoperative
Secondary outcomes:
measure: Postoperative ankle AOFAS scale
timeFrame: Postoperative 1,6,12 months
measure: Fusion rate
timeFrame: Postoperative 1,6,12 months
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Southwest Hospital
state: Chongqing
Study officials:
affiliation: Southwest Hospital, China
name: Xiaojun Duan, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.