Accelerated Aging Effect on the Stability of the 3D-Printed Biodegradable Implant for Bone Defect Repairs.

Area of Science:

• Biomaterials Science
• Orthopedic Engineering
• Medical Device Development

Background:

• Biodegradable implants are crucial for bone defect repair, especially in pediatric patients where bone growth is ongoing.
• 3D printing offers patient-specific solutions for complex bone defects.
• Assessing implant longevity under simulated use is vital for clinical application.

Purpose of the Study:

• To evaluate the impact of accelerated aging on the structural properties of 3D-printed biodegradable PLA/HAp bone implants.
• To determine the shelf-life and confirm the safety and effectiveness of these implants for pediatric traumatic bone defect treatment.
• To assess changes in physicomechanical and chemical properties after simulated long-term storage and use.

Main Methods:

• Biodegradable PLA/HAp implants were fabricated using 3D printing technology.
• Implants underwent sterilization (25 kGy radiation) and accelerated aging per ASTM F 1980:2002, simulating three years of use.
• Physicomechanical and chemical properties were analyzed using FT-IR spectra and Differential Scanning Calorimetry (DSC).

Main Results:

• Accelerated aging confirmed the stability of structural, physical, and mechanical properties of the PLA/HAp implants.
• FT-IR and DSC analyses indicated no significant degradation affecting implant performance.
• The study demonstrated the effectiveness and safety of the implants for their intended application.

Conclusions:

• 3D-printed biodegradable PLA/HAp implants exhibit stable properties after accelerated aging, suitable for traumatic bone defect repair.
• The findings support the use of these implants in pediatric and adolescent patients, ensuring safety throughout their shelf-life.
• Accelerated aging methodologies effectively predict long-term performance and safety of medical devices for growing bone.