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3D Printed Guide in Ankle Arthrodesis

3D Printed Customized Guide in Ankle Arthrodesis

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03626935
Enrollment
10
Registered
2018-08-13
Start date
2014-01-01
Completion date
2019-07-31
Last updated
2019-03-22

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

Conditions

Ankle Injuries

Keywords

ankle joint, arthrodesis, 3d printing, customized guide

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.

Interventions

DEVICE3D-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.

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 ankle arthrodesis and consider internal fixation with screws

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Operation timeIntraoperativeOperation time for internal fixation

Secondary

MeasureTime frameDescription
Postoperative ankle AOFAS scalePostoperative 1,6,12 monthsPostoperative 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.
Fusion ratePostoperative 1,6,12 monthsFusion rate of the ankle joint

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026