3D-Printed Personalized Metal Implant in Surgical Treatment of Ankle Bone Defects
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Bone Diseases
- Sponsor
- Southwest Hospital, China
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Visual Analogue Scale (VAS)
- Last Updated
- 8 years ago
Overview
Brief Summary
This study aims to use 3D-printed personalized metal implants for bone defect surgeries in order to reduce pain of the patients.
Detailed Description
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.
Investigators
Xiaojun Duan
Deputy Director of the Center for Joint Surgery
Southwest Hospital, China
Eligibility Criteria
Inclusion Criteria
- •Receive ankle or subtalar arthrodesis;
- •Refuse to use autologous bone graft or allogeneic bone graft.
Exclusion Criteria
- •The local defect area is small;
- •Refuse to use permanent metal metal implant.
Outcomes
Primary Outcomes
Visual Analogue Scale (VAS)
Time Frame: Postoperative 24 months
The decrease in VAS score from baseline
Secondary Outcomes
- Osteotylus growth(Postoperative 24 months)
- Implant displacement(Postoperative 24 months)
- Lower limb alignment(Postoperative 24 months)
- American Orthopedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Scale(Postoperative 24 months)