Using 3D-printed implants to treat long bone defects
The Effectiveness in the Treatment of Long Bone Defect in Adults Using 3D-printed Titanium Alloy Implant
EARLY_PHASE1 · Cho Ray Hospital · NCT04449211
This study is testing if custom-made 3D-printed titanium implants can help adults with serious bone loss from injuries or tumors heal better.
Quick facts
| Phase | EARLY_PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cho Ray Hospital (other) |
| Locations | 1 site (Ho Chi Minh City) |
| Trial ID | NCT04449211 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of customized 3D-printed titanium alloy implants for treating long bone defects in adults. Participants with significant bone loss due to trauma or tumor resection will undergo CT scans to design patient-specific implants. The implants are created using advanced Electron Beam Melting technology and undergo rigorous mechanical testing to ensure they meet safety and efficacy standards before implantation. The process involves collaboration with international experts to ensure precision and quality in the implant design and manufacturing.
Who should consider this trial
Good fit: Ideal candidates are adults with health insurance who have a bone defect greater than 5cm due to trauma or tumor resection.
Not a fit: Patients with contraindications to surgery, local infections, or soft tissue defects may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve recovery outcomes for patients with long bone defects.
How similar studies have performed: Other studies have shown promise in using 3D-printed implants for similar applications, indicating a growing body of evidence supporting this innovative approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult participants with health insurance regardless of sex having bone defect greater than 5cm due to trauma or tumour resection agree to participate the research Exclusion Criteria: * Participants with contraindication to surgery * Participants do not agree to undergo surgery * Participants with local infection or soft tissue defect
Where this trial is running
Ho Chi Minh City
- Cho Ray hospital — Ho Chi Minh City, Vietnam (RECRUITING)
Study contacts
- Study coordinator: Hung Do Phuoc, MD, PhD
- Email: dphungcr@ump.edu.vn
- Phone: +84903775579
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Bone Loss, Defect Limb, bone defect, 3D-printed Titanium alloy implant, Electron Beam Melting, customised implant, patient-specific implant