Managing bone defects.
Aaron Nauth, Michael D McKee, Thomas A Einhorn...
https://pubmed.ncbi.nlm.nih.gov/21738065Actively Recruiting
Early Phase 1
Age: 18Years +
All Genders
ID04449211
The Effectiveness in the Treatment of Long Bone Defect in Adults Using 3D-printed Titanium Alloy Implant
Led by Cho Ray Hospital · Updated on 2024-09-03
10
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
C
Cho Ray Hospital
Lead Sponsor
C
Commonwealth Scientific and Industrial Research Organisation, Australia
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate the effectiveness of 3D-printed titanium alloy implants in treating adults with long bone defects caused by trauma or tumor resection. The study focuses on reconstructing these bone defects to improve limb function and recovery. Participants undergo a full CT scan of both limbs to help design a custom implant based on the healthy limb's data. The implant is made from Titanium - 6 Aluminum - 4 Vanadium ELI using Electron Beam Melting technology and tested for mechanical strength in Australia. Once approved, the implant is post-processed, sterilized, and prepared for surgery. During the study, researchers will record surgical details like blood loss and operative time. Participants' limb function will be assessed from 1 to 12 months after surgery using functional and radiological imaging outcomes. Complications will be monitored throughout the study, which lasts approximately one year.
CONDITIONS
Brief Title
The Effectiveness in the Treatment of Long Bone Defect Using 3D-printed Implant
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adult participants with health insurance regardless of sex
- Bone defect greater than 5 cm due to trauma or tumor resection
- Agree to participate in the research
You will not qualify if you...
- Contraindication to surgery
- Do not agree to undergo surgery
- Local infection or soft tissue defect
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Implementation
Duration - Up to 1 day for surgery
Participants undergo surgery to reconstruct the long bone defect using a customised 3D-printed Titanium alloy implant.
1 surgical visit (in-person)
Post-operative Follow-up
Duration - Up to 12 months
Participants are monitored for functional and radiological outcomes, complications, and recovery after the implant surgery.
Multiple visits from post-operative day 1 to 12 months
Trial Site Locations
Total: 1 location
1
Cho Ray hospital
Ho Chi Minh City, Vietnam, 700000
Actively Recruiting
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Research Team
H
Hung Do Phuoc, MD, PhD
P
Phu Nguyen Hoang, MD, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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