High-Temperature Polylactic Acid Proves Reliable and Safe for Manufacturing 3D-Printed Patient-Specific Instruments...

Area of Science:

• Orthopedic Surgery
• Biomaterials Engineering
• Medical Device Manufacturing

Background:

• 3D-printed personalized surgical instruments (3DP-PSIs) are revolutionizing orthopedic surgery by enhancing precision and reducing complications.
• Hospitals are increasingly adopting in-house 3D printing, utilizing cost-effective Fused Deposition Modeling (FDM) with Polylactic acid (PLA).
• Annealing High-Temperature PLA (ann-HTPLA) addresses PLA's temperature limitations, enabling steam sterilization and maintaining material integrity for surgical applications.

Purpose of the Study:

• To evaluate the in vivo safety and efficacy of ann-HTPLA 3DP-PSIs in pediatric orthopedic surgery.
• To assess the usability and complication rates associated with 3DP-PSIs produced at an in-office 3D-printing Point-of-Care (3DP-PoC).
• To determine the suitability of ann-HTPLA for creating patient-specific instruments for correcting limb deformities.

Main Methods:

• Utilized ann-HTPLA 3DP-PSIs manufactured at an in-office 3DP-PoC for pediatric limb deformity correction.
• Collected data on 3DP-PSI dimensions, printing parameters, intraoperative usability, and patient complications.
• Analyzed 83 ann-HTPLA 3DP-PSIs used across 33 patients involving 47 bone segments.

Main Results:

• Ninety-five percent (79/83) of ann-HTPLA 3DP-PSIs were used effectively without complications.
• Eleven complications occurred across 47 procedures, with 2 infections (4.3%).
• Intraoperative use of 3DP-PSIs did not significantly elevate infection or complication rates.

Conclusions:

• ann-HTPLA demonstrates satisfactory usability and safety for producing 3DP-PSIs.
• In-office 3DP-PoC using ann-HTPLA is a viable option for creating personalized orthopedic surgical instruments.
• This technology offers a cost-effective and precise solution for pediatric orthopedic interventions.