3D-printed Patient-Specific Implants made of Polylactide (PLDLLA) and β-Tricalcium Phosphate (β-TCP) for Corrective Osteotomies of The Distal Radius

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Abstract

The most common surgical procedure to manage the malunion of the bones is corrective osteotomy. The current gold standard for securing the bone segments after osteotomy is the use of titanium plates and allografts which has disadvantages such as possible allergic reaction, additional operations such as extraction of the graft from other sites and removal operation. The utilization of resorbable materials presents an opportunity to mitigate these drawbacks, but has not yet been thoroughly researched in literature. This study assesses viability of using biodegradable, 3D-printed patient-specific implants made of Poly(-L-lactide-co-D,L-lactide) (PLDLLA) and β-Tricalcium Phosphate (β-TCP) as an alternative material in an in-vitro biomechanical study involving ex vivo biomechanical compression testing, biodegradation testing, and calorimetric measurements.. These implants possess a unique shape, resembling a wedge and are fixated as a connection between the osteotomized bone using resorbable screws. Following point-of-care virtual planning, bio-mechanical compressive tests with (n = 5) ex vivo radii equipped with PLDLLA/ β-TCP implants were performed to prove sufficient stability of the connection. All PLDLLA/ β-TCP implants withstood a compressive force of at least 1’211 N which exceeds the maximum force reported in literature in case of a fall from the height of 1 m. Furthermore, the results showed a consistent surface chemistry and slow degradation rate. The outcomes are encouraging, establishing the groundwork for an innovative distal radius corrective osteotomy surgical method. However, further research is necessary to thoroughly evaluate the long-term biodegradability and mechanical efficacy of the implants.

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