3D-Printed Personalized Metal Implant in Surgical Treatment of Ankle Bone Defects
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|ClinicalTrials.gov Identifier: NCT03185286|
Recruitment Status : Recruiting
First Posted : June 14, 2017
Last Update Posted : June 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|Bone Diseases||Device: 3d-printed personalized metal implant||Not Applicable|
Bone defects are common in ankle disease, and the conventional treatment includes autologous or allogeneic bone grafts. However, autologous bone graft may cause complications and its source is rather limited; allogeneic bone graft may cause disease transmission and the mechanical strength of the graft is low after processing.
The 3D printing technology has provided a new way of solving this problem. It has the following technical advantages: wide range of graft sources, high mechanical strength, and can be prepared in advance according to various shapes.
Preparation procedure: first, establish the individualized ankle model according to the patient's ankle CT scan data and then prepare the implant model; second, conduct surgery rehearsal and place the implant model in the ankle model for observation; third, after confirmation, use titanium alloy in the 3D printing machine to prepare the individualized metal implant, which is in line with the Chinese National Standard "Wrought titanium and titanium alloy for surgical implants" (GB/T 13810-2007); fourth, implant the individualized metal implant into the bone defect area after sterilization.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||3D-Printed Personalized Metal Implant in Surgical Treatment of Ankle Bone Defects|
|Actual Study Start Date :||December 31, 2015|
|Estimated Primary Completion Date :||December 31, 2018|
|Estimated Study Completion Date :||December 31, 2019|
Experimental: 3D-printed personalized metal implant
3D-printed personalized metal implant will be used in bone defect surgeries.
Device: 3d-printed personalized metal implant
3d-printed personalized metal implant will be used in subtalar arthrodesis.
- Visual Analogue Scale (VAS) [ Time Frame: Postoperative 24 months ]The decrease in VAS score from baseline
- American Orthopedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Scale [ Time Frame: Postoperative 24 months ]The increase in AOFAS score from baseline
- Lower limb alignment [ Time Frame: Postoperative 24 months ]Analyze the lower limb alignment by radiography
- Osteotylus growth [ Time Frame: Postoperative 24 months ]Analyze the osteotylus growth by radiography
- Implant displacement [ Time Frame: Postoperative 24 months ]Assess the implant displacement by radiography
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03185286
|Contact: Xiaojun Duan, MDfirstname.lastname@example.org|
|Chongqing, Chongqing, China, 400030|
|Contact: Xiaojun Duan, MD 86-23-68765290 email@example.com|
|Principal Investigator:||Xiaojun Duan, MD||Southwest Hospital, China|