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Application of 3D Printing Technology in Subtalar Arthrodesis

Application of 3D Printing Technology in Subtalar Arthrodesis

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03152916
Enrollment
10
Registered
2017-05-15
Start date
2014-01-01
Completion date
2018-12-31
Last updated
2018-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankle Injuries

Keywords

subtalar joint, arthrodesis, 3d printing

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.

Interventions

DEVICE3d printing personalized plate

3d printing personalized plate will be used in the subtalar arthrodensis

Sponsors

Southwest Hospital, China
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Operation timeIntraoperativeOperation time for internal fixation

Secondary

MeasureTime frameDescription
Postoperative subtalar VAS scorePostoperative 1,6,12 monthsPostoperative subtalar VAS score of the patients
Fusion ratePostoperative 1,6,12 monthsFusion rate of the subtalar joint

Countries

China

Contacts

Primary ContactXiaojun Duan, MD
duanxiaojun@hotmail.com86-23-68765290

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026