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陶瓷骨移植替代物(镁羟基磷灰石)用于脊柱融合术:一项前瞻性初步研究。

Ceramic bone graft substitute (Mg-HA) in spinal fusion: A prospective pilot study.

作者信息

Griffoni Cristiana, Tedesco Giuseppe, Canella Valentina, Nataloni Angelo, Zerbi Alberto, Tosini Giovanni, Gasbarrini Alessandro, Barbanti-Brodano Giovanni

机构信息

Department of Spine Surgery, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy.

Finceramica Faenza S.p.A., Faenza, Italy.

出版信息

Front Bioeng Biotechnol. 2022 Nov 17;10:1050495. doi: 10.3389/fbioe.2022.1050495. eCollection 2022.

Abstract

Iliac crest bone graft (ICBG) is considered the gold standard for spine surgical procedures to achieve a successful fusion due to its known osteoinductive and osteoconductive properties. However, complications related to harvesting procedure and donor site morbidity have been largely reported in the literature, favoring the development of a wide range of alternative products to be used as bone graft extenders or substitutes for spine fusion. Among all, ceramic-based biomaterials have been widely studied and employed in the last years as bone graft substitutes. We report here the results of a prospective pilot study aimed to evaluating the grade of ossification obtained by the use of an Mg-doped hydroxyapatite (HA) product to achieve postero-lateral fusion in degenerative spine diseases. Results show a successful degree of fusion of about 62% at the 12-month follow-up and an improvement of quality of life and health status following surgery, as evaluated by clinical scores (ODI, VAS, and EQ-5L). No adverse events related to the material were reported. The present pilot study shows the effectiveness and the safety profile of an Mg-doped HA bone graft substitute used to achieve postero-lateral fusion in the treatment of degenerative spine diseases, laying down the basis for further larger clinical investigations.

摘要

由于其已知的骨诱导和骨传导特性,髂嵴骨移植(ICBG)被认为是脊柱外科手术实现成功融合的金标准。然而,与采集过程相关的并发症和供体部位发病率在文献中已有大量报道,这促使人们开发了多种替代产品,用作骨移植扩展剂或脊柱融合替代品。其中,基于陶瓷的生物材料在过去几年中作为骨移植替代品得到了广泛研究和应用。我们在此报告一项前瞻性试点研究的结果,该研究旨在评估使用镁掺杂羟基磷灰石(HA)产品在退行性脊柱疾病中实现后外侧融合所获得的骨化程度。结果显示,在12个月的随访中,融合成功率约为62%,并且通过临床评分(ODI、VAS和EQ-5L)评估,术后生活质量和健康状况有所改善。未报告与该材料相关的不良事件。本试点研究显示了镁掺杂HA骨移植替代品在治疗退行性脊柱疾病中实现后外侧融合的有效性和安全性,为进一步开展更大规模的临床研究奠定了基础。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ff48/9748738/46cac57376c1/fbioe-10-1050495-g001.jpg

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