Design, characterisation, and clinical evaluation of a novel porous Ti-6Al-4V hemipelvic prosthesis based on Voronoi diagram

doi:10.12336/biomatertransl.2024.03.007

Biomaterials Translational ›› 2024, Vol. 5 ›› Issue (3): 314-324.doi: 10.12336/biomatertransl.2024.03.007

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Design, characterisation, and clinical evaluation of a novel porous Ti-6Al-4V hemipelvic prosthesis based on Voronoi diagram

Zhuangzhuang Li¹^,², Yi Luo¹^,², Minxun Lu¹^,², Yitian Wang¹^,², Linsen Zhong³, Yong Zhou¹^,², Zhenfeng Duan⁴, Li Min¹^,²^,^*(), Chongqi Tu¹^,²^,^*()

1 Orthopaedic Research Institute and Department of Orthopaedics, West China Hospital, Sichuan University, Chengdu, Sichuan Province, China
2 Model Worker and Craftsman Talent Innovation Workshop of Sichuan Province, Chengdu, Sichuan Province, China
3 Tianqi Additive Manufacturing Co., Ltd, Chengdu, Sichuan Province, China
4 Department of Orthopaedic Surgery, Sarcoma Biology Laboratory, Sylvester Comprehensive Cancer Centre, and The University of Miami Miller School of Medicine, Miami, FL, USA

Received:2024-07-22 Revised:2024-08-28 Accepted:2024-09-13 Online:2024-09-28 Published:2024-09-28
Contact: Li Min,Chongqi Tu E-mail:minli1204@scu.edu.cn;tucq@scu.edu.cn
About author:Chongqi Tu, tucq@scu.edu.cn.
Li Min, minli1204@scu.edu.cn;

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Abstract

Abstract:

Three-dimensional printed Ti-6Al-4V hemipelvic prosthesis has become a current popular method for pelvic defect reconstruction. This paper presents a novel biomimetic hemipelvic prosthesis design that utilises patient-specific anatomical data in conjunction with the Voronoi diagram algorithm. Unlike traditional design methods that rely on fixed, homogeneous unit cell, the Voronoi diagram enables to create imitation of trabecular structure (ITS). The proposed approach was conducted for six patients. The entire contour of the customised prosthesis matched well with the residual bone. The porosity and pore size of the ITS were evaluated. The distribution of the pore size ranged from 500 to 1400 μm. Porosity calculations indicated the average porosity was 63.13 ± 0.30%. Cubic ITS samples were fabricated for micrograph and mechanical analysis. Scanning electron microscopy images of the ITS samples exhibited rough surface morphology without obvious defects. The Young’s modulus and compressive strength were 1.68 ± 0.05 GPa and 174 ± 8 MPa, respectively. Post-operative X-rays confirmed proper matching of the customised prostheses with the bone defect. Tomosynthesis-Shimadzu metal artifact reduction technology images indicated close contact between the implant and host bone, alongside favourable bone density and absence of resorption or osteolysis around the implant. At the last follow-up, the average Musculoskeletal Tumour Society score was 23.2 (range, 21–26). By leveraging additive manufacturing and Voronoi diagram algorithm, customised implants tailored to individual patient anatomy can be fabricated, offering wide distribution of the pore size, reasonable mechanical properties, favourable osseointegration, and satisfactory function.

Key words: 3D printing, biomimetic prosthesis, bone tumour, pelvic defect reconstruction, porous structure

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Figures/Tables 11

Table 1. Demographics, clinical characteristics, and follow-up outcomes of six patients

Case	Sex	Age (year)	Diagnosis	Enneking zone	Operation time (minute)	Blood loss (mL)	Follow-up (month)	MSTS score	Complication	Oncological status
1	M	55	Chondrosarcoma	II+III	330	300	24	25	-	NED
2	F	48	Metastasis	II	358	700	22	25	-	AWD
3	F	53	Metastasis	I+II+III	195	400	23	24	-	AWD
4	M	67	Chondrosarcoma	I+II+III	295	1500	18	22	-	NED
5	M	45	Haemangioma	I+II+III	316	3000	20	23	DWH	NED
6	F	61	Metastasis	I+II+IV	314	5000	15	20	-	AWD

Figure 1. Workflow of designing the customised hemipelvic prosthesis with ITS. (A-G) Segmentation of the pelvis 3D model (A), determination of the osteotomy planes (B), simulation of the tumour resection (C), design of the guiding plate for bone-cutting (D), prosthesis model by mirroring the contralateral unaffected hemipelvis, followed by modifications (E), distribution of the porous part and solid architecture within the prosthesis model (F), creation of the ITS through the Voronoi diagram (G). 3D: three-dimensional; ITS: imitation of trabecular structure.

Figure 2. (A) Three-dimensional models of the reconstructed pelvis at the anteroposterior, inlet and outlet views. (B) The prosthesis models with delicate-defined solid architecture and porous structure. (C) The distribution of the pore size ranging from 500 to 1400 μm. (D, E) The average pore size (D) and the porosity (E).

Table 2. Details of the customised hemipelvic prosthesis models

Case	Imitation of trabecular structure				Large pore size-imitation of trabecular structure
Case	Distribution of the pore size (μm)	Average pore size (μm)	Unit cell strut thickness (μm)	Porosity (%)	Distribution of the pore size (μm)	Average pore size (μm)	Unit cell strut thickness (μm)	Porosity (%)
1	502–1397	917	400	63.29	–	–	–	–
2	508–1395	914	400	62.89	–	–	–	–
3	501–1398	919	400	63.19	505–1893	1256	600	63.93
4	500–1381	916	400	62.65	509–1897	1285	600	64.54
5	502–1391	918	400	63.43	501–1898	1248	600	64.32
6	503–1390	919	400	63.31	500–1894	1251	600	64.28

Figure 3. The characterisation of the Ti-6Al-4V powder utilised in this work. (A) Morphology; (B, C) chemical composition; (D) particle size distribution.

Figure 4. (A, B) SEM images of the cubic ITS and L-ITS samples. (C, D) Micro-CT scans of the cubic ITS and L-ITS samples. (E, F) The stress-strain curves of the as-fabricated ITS and L-ITS samples. ITS: imitation of trabecular structure; L-ITS: large pore size imitation of trabecular structure; Micro-CT: micro-computed tomography; SEM: scanning electron microscopy.

Figure 5. (A) The photographs of prostheses fabricated by EBM. (B, C) Intraoperative photographs of tumour resection and prosthesis implantation. EBM: electron beam melting; ITS: Imitation of trabecular structure; L-ITS: large pore size imitation of trabecular structure.

Figure 6. Post-operative pelvic X-rays confirmed proper matching of the customised prostheses with the bone defect. Tomosynthesis-Shimadzu metal artifact reduction technology images of typical 2 patients two months after surgery indicated close contact between the implant and host bone, alongside favourable bone density and absence of resorption or osteolysis around the implant.

Table 3. Previous studies on the application of three-dimensional-printed hemipelvic prosthesis

Study	Porous type	Pore size (μm)	Mean follow-up (month)	Osseointegration outcome	Mechanical stability outcome	Patient-reported outcomes (MSTS score)
Wong et al.³³	Regular	720	10	NA	No loosening	NA
Peng et al.¹²	Honeycomb like	400–450	33	NA	No loosening	19.8
Xu et al.¹⁸	Irregular	600	22	Good	No loosening	22.0
Han et al.⁵⁰	Regular	400	12	NA	No loosening	16.0
Current study	Voronoi-based	917 (500–1400)	20	Good	No loosening	23.2

Additional Figure 1. The pore size of the Voronoi unit cell was assessed through “pore sphere” analysis.

Additional Figure 2. The distribution of the pore size among the L-ITS ranges from 500 to 1900 μm. (A–D) Cases 3–6.L-ITS: large pore size imitation of trabecular structure.

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Design, characterisation, and clinical evaluation of a novel porous Ti-6Al-4V hemipelvic prosthesis based on Voronoi diagram

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