A gap-filling, regenerative implant for open-wedge osteotomy

Margot Rikkers , H. Chien Nguyen , Nasim Golafshan , Mylène de Ruijter , Riccardo Levato , Lucienne A. Vonk , Nienke van Egmond , Miguel Castilho , Roel J.H. Custers , Jos Malda
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引用次数: 0

Abstract

Introduction

In patients suffering from unilateral osteoarthritis in the knee, an osteotomy can provide symptomatic relief and postpone the need for replacement of the joint. Nevertheless, open-wedge osteotomies (OWOs) around the knee joint face several challenges like postoperative pain and bone nonunion.

Objectives

In this study, the aim was to design, fabricate, and evaluate a gap-filling implant for OWO using an osteoinductive and degradable biomaterial.

Methods

Design of porous wedge-shaped implants was based on computed tomography scans of cadaveric legs. Implants were 3-dimensionally printed using a magnesium strontium phosphate-polycaprolactone (MgPSr-PCL) biomaterial ink. Standardized scaffolds with different inter-fiber spacing (IFS) were mechanically characterized and osteoinductive properties of the biomaterial were assessed in vitro. Finally, human-sized implants with different heights (5 mm, 10 mm, 15 mm) were designed and fabricated for ex vivo implantation during 3 OWO procedures in human cadaveric legs.

Results

Implants printed with an interior of IFS-1.0 resulted in scaffolds that maintained top and bottom porosity, while the interior of the implant exhibited significant mechanical stability. Bone marrow concentrate and culture expanded mesenchymal stromal cells attached to the MgPSr-PCL material and proliferated over 21 days in culture. The production of osteogenic markers alkaline phosphatase activity, calcium, and osteocalcin was promoted in all culture conditions, independent of osteogenic induction medium. Finally, 3 OWO procedures were planned and fabricated wedges were implanted ex vivo during the procedures. A small fraction of one side of the wedges was resected to assure fit into the proximal biplanar osteotomy gap. Preplanned wedge heights were maintained after implantation as measured by micro-computed tomography.

Conclusion

To conclude, personalized implants for implantation in OWOs were successfully designed and manufactured. The implant material supported osteogenesis of mesenchymal stromal cells and bone marrow concentrate in vitro and full-size implants were successfully implemented into the surgical procedure without compromising preplanned wedge height.

用于开放式楔形截骨术的间隙填充再生植入物
导言:对于患有单侧膝关节骨性关节炎的患者,截骨术可以缓解症状,推迟关节置换的需要。然而,膝关节周围的开放性楔形截骨术(OWO)面临着术后疼痛和骨不愈合等挑战。方法根据尸体腿部的计算机断层扫描结果设计多孔楔形植入物。使用磷酸锶镁-聚己内酯(MgPSr-PCL)生物材料墨水对植入物进行三维打印。对具有不同纤维间距(IFS)的标准化支架进行了机械表征,并在体外评估了生物材料的骨诱导特性。最后,设计并制作了不同高度(5 毫米、10 毫米、15 毫米)的人体大小植入物,在人体尸体腿部的 3 次 OWO 手术中进行体内外植入。骨髓浓缩物和培养扩增的间充质基质细胞附着在 MgPSr-PCL 材料上,并在 21 天的培养过程中不断增殖。在所有培养条件下,成骨标志物碱性磷酸酶活性、钙和骨钙素的生成都得到了促进,与成骨诱导培养基无关。最后,计划进行 3 次 OWO 手术,并在手术过程中将制作好的楔块植入体外。楔块的一侧被切除一小部分,以确保与近端双平面截骨间隙相匹配。通过微型计算机断层扫描测量,植入后保持了预先计划的楔形高度。植入体材料支持间充质基质细胞和骨髓浓缩物在体外的成骨作用,全尺寸植入体在不影响预规划楔形高度的情况下成功应用于手术过程。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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