Department of Orthopaedics and Traumatology, Ghent University Hospital, Ghent, Belgium.
Am J Sports Med. 2011 Apr;39(4):774-82. doi: 10.1177/0363546511398040. Epub 2011 Mar 7.
A novel, biodegradable, aliphatic polyurethane scaffold was designed to fulfill an unmet clinical need in the treatment of patients with irreparable partial meniscal lesions.
Treatment of irreparable partial meniscal lesions with an acellular polyurethane scaffold supports new tissue ingrowth.
Case series; Level of evidence, 4.
Fifty-two patients (with 34 medial and 18 lateral lesions) were recruited into a prospective, single-arm, multicenter, proof-of-principle study and treated with the polyurethane scaffold. The scaffold was implanted after partial meniscectomy using standard surgeon-preferred techniques for suturing. Tissue ingrowth was assessed at 3 months by dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) and at 12 months by gross examination during second-look arthroscopy, in the course of which a biopsy sample from the inner free edge of the scaffold meniscus was taken for qualitative histologic analysis.
Tissue ingrowth at 3 months was demonstrated on DCE-MRI in 35 of 43 (81.4%) patients. All but one 12-month second-look (43 of 44 [97.7%]) showed integration of the scaffold with the native meniscus and all biopsy specimens (44) showed fully vital material, with no signs of cell death or necrosis. Three distinct layers were observed based on morphologic structure, vessel structure presence or absence, and extracellular matrix composition.
The DCE-MRI demonstrated successful early tissue ingrowth into the scaffold. The biopsy findings demonstrated the biocompatibility of the scaffold and ingrowth of tissue with particular histologic characteristics suggestive of meniscus-like tissue. In conclusion, these data show for the first time consistent regeneration of tissue when using an acellular polyurethane scaffold to treat irreparable partial meniscus tissue lesions.
设计了一种新型可生物降解的脂肪族聚氨酯支架，以满足治疗不可修复的半月板部分损伤患者的临床需求。
使用去细胞聚氨酯支架治疗不可修复的半月板部分损伤可支持新组织的长入。
病例系列；证据水平，4 级。
52 例患者（34 例内侧和 18 例外侧病变）入组前瞻性、单臂、多中心、原理验证研究，并接受聚氨酯支架治疗。支架在半月板部分切除术后使用标准的外科医生首选缝合技术植入。通过动态对比增强磁共振成像（DCE-MRI）在 3 个月时评估组织长入，在 12 个月时通过第二次关节镜检查时的大体检查评估，在此过程中从支架半月板的内游离缘取活检样本进行定性组织学分析。
在 43 例（81.4%）患者中的 35 例中，DCE-MRI 在 3 个月时显示出组织长入。除了 1 例（44 例中有 1 例）在 12 个月的第二次观察中未显示出组织整合（97.7%）外，所有患者的支架均与正常半月板整合，所有活检标本（44 例）均显示出完全有活力的材料，无细胞死亡或坏死的迹象。根据形态结构、血管结构的存在与否以及细胞外基质的组成，观察到 3 个不同的层。
DCE-MRI 显示支架内的组织成功地早期长入。活检结果显示了支架的生物相容性和具有特定组织学特征的组织的长入，这些特征提示类似半月板的组织。总之，这些数据首次显示，使用去细胞聚氨酯支架治疗不可修复的半月板组织病变时，组织可一致再生。
