- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03626935
3D Printed Guide in Ankle Arthrodesis
3D Printed Customized Guide in Ankle Arthrodesis
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Chongqing
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Chongqing, Chongqing, China, 400030
- Southwest Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Device Feasibility
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 3D-printed customized guide plate
3D-printed customized guide plate will be used to guide the Kirschner wires in ankle arthrodesis.
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3D-printed customized guide plate will be used in the ankle arthrodesis to help reduce operation time and reduce intra-operative radiation.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Operation time
Time Frame: Intraoperative
|
Operation time for internal fixation
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Intraoperative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative ankle AOFAS scale
Time Frame: Postoperative 1,6,12 months
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Postoperative 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.
|
Postoperative 1,6,12 months
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Fusion rate
Time Frame: Postoperative 1,6,12 months
|
Fusion rate of the ankle joint
|
Postoperative 1,6,12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Xiaojun Duan, M.D., Southwest Hospital, China
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3DAnkleGuide
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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