This study aims to use 3D-printed personalized metal implants for bone defect surgeries in order to reduce pain of the patients.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
3d-printed personalized metal implant will be used in subtalar arthrodesis.
Southwest Hospital
Chongqing, Chongqing Municipality, China
RECRUITINGVisual Analogue Scale (VAS)
The decrease in VAS score from baseline
Time frame: Postoperative 24 months
American Orthopedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Scale
The increase in AOFAS score from baseline
Time frame: Postoperative 24 months
Lower limb alignment
Analyze the lower limb alignment by radiography
Time frame: Postoperative 24 months
Osteotylus growth
Analyze the osteotylus growth by radiography
Time frame: Postoperative 24 months
Implant displacement
Assess the implant displacement by radiography
Time frame: Postoperative 24 months
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