Clinical trial NCT03152916: Application of 3D Printing Technology in Subtalar Arthrodesis
Official title: Application of 3D Printing Technology in Subtalar Arthrodesis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ankle Injuries
Keywords: subtalar joint
arthrodesis
3d printing
Lead sponsor: Southwest Hospital, China
Sponsor class: OTHER
First posted: 2017-05-15
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 aims to use 3D printing personalized plate to locate the position in which the K-wires would be drilled to save operation time and decrease the number of times that the K-wires are drilled.

Detailed description: Subtalar arthrodesis is a standard procedure for treating joint injuries in terminal stage. In this study, in order to improve efficacy and shorten the operation time, personalized plate is prepared before surgery. During the surgery, the articular cartilage is scraped, then the fusion joint is reset to the functional position; the 2-2mm Kirschner wires are drilled with the assistance of the personalized plate,then the position of the fusion joint as well as the Kirschner wires are confirmed under the C-arm; lastly, cannulated screws are screwed in along the Kirschner wires for effective fixation.

In the past surgeries without personalized plate, surgeons could only rely on their experience to locate the position for drilling and then confirm under the C-arm. This would prolong the operation time and be more traumatic to the patients. Using 3D printing personalized plate can solve this problem.

The preparation procedure for the personalized plate: firstly, ankle model are established according to the patient's CT scan data, then select modular pieces to prepare the personalized plate, sterilize it for future use. Apply conventional surgical treatment to the subtalar surface, reset the fusion joint to the functional position, and drill 2-2mm Kirschner wires with the guidance of the plate. If the locations of the fusion joint and the Kirschner wires are satisfying under the C-arm inspection, drill the hollow screw for final fixation.

Eligibility criteria: Inclusion Criteria:

* Patients who receive subtalar arthrodesis and consider internal fixation with screws

Exclusion Criteria:

* Patients who receive subtalar arthrodesis but do not consider internal fixation with screws

Primary outcomes:
measure: Operation time
timeFrame: Intraoperative
Secondary outcomes:
measure: Postoperative subtalar VAS score
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, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhang C, Cao J, Zhu H, Fan H, Yang L, Duan X. Endoscopic Treatment of Symptomatic Foot and Ankle Bone Cyst with 3D Printing Application. Biomed Res Int. 2020 Dec 26;2020:8323658. doi: 10.1155/2020/8323658. eCollection 2020.