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3D-Printed Personalized Metal Implant in Surgical Treatment of Ankle Bone Defects

3D-Printed Personalized Metal Implant in Surgical Treatment of Ankle Bone Defects

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03185286
Enrollment
40
Registered
2017-06-14
Start date
2015-12-31
Completion date
2019-12-31
Last updated
2017-06-14

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

Conditions

Bone Diseases

Keywords

3D printing, metal implant, bone defect

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.

Interventions

DEVICE3d-printed personalized metal implant

3d-printed personalized metal implant will be used in subtalar arthrodesis.

Sponsors

Southwest Hospital, China
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Visual Analogue Scale (VAS)Postoperative 24 monthsThe decrease in VAS score from baseline

Secondary

MeasureTime frameDescription
American Orthopedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot ScalePostoperative 24 monthsThe increase in AOFAS score from baseline
Lower limb alignmentPostoperative 24 monthsAnalyze the lower limb alignment by radiography
Osteotylus growthPostoperative 24 monthsAnalyze the osteotylus growth by radiography
Implant displacementPostoperative 24 monthsAssess the implant displacement by radiography

Countries

China

Contacts

Primary ContactXiaojun Duan, MD
duanxiaojun@hotmail.com86-23-68765290

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026