van der Stok J, Hartholt K A, Schoenmakers D A L, Arts J J C
Department of Orthopaedics, Reinier de Graaf Group, Delft, and Erasmus MC, University Medical Centre Rotterdam, Rotterdam, The Netherlands.
Department of Surgery-Traumatology, Reinier de Graaf Group, Delft, The Netherlands.
Bone Joint Res. 2017 Jul;6(7):423-432. doi: 10.1302/2046-3758.67.BJR-2017-0027.R1.
The aim of this systematic literature review was to assess the clinical level of evidence of commercially available demineralised bone matrix (DBM) products for their use in trauma and orthopaedic related surgery.
A total of 17 DBM products were used as search terms in two available databases: Embase and PubMed according to the Preferred Reporting Items for Systematic Reviews and Meta Analyses statement. All articles that reported the clinical use of a DBM-product in trauma and orthopaedic related surgery were included.
The literature search resulted in 823 manuscripts of which 64 manuscripts met the final inclusion criteria. The included manuscripts consisted of four randomised controlled trials (level I), eight cohort studies (level III) and 49 case-series (level IV). No clinical studies were found for ten DBM products, and most DBM products were only used in combination with other grafting materials. DBM products were most extensively investigated in spinal surgery, showing limited level I evidence that supports the use Grafton DBM (Osteotech, Eatontown, New Jersey) as a bone graft extender in posterolateral lumbar fusion surgery. DBM products are not thoroughly investigated in trauma surgery, showing mainly level IV evidence that supports the use of Allomatrix (Wright Medical, London, United Kingdom), DBX (DePuy Synthes, Zuchwil, Switzerland), Grafton DBM, or OrthoBlast (Citagenix Laval, Canada) as bone graft extenders.
The clinical level of evidence that supports the use of DBM in trauma and orthopaedic surgery is limited and consists mainly of poor quality and retrospective case-series. More prospective, randomised controlled trials are needed to understand the clinical effect and impact of DBM in trauma and orthopaedic surgery. J. van der Stok, K. A. Hartholt, D. A. L. Schoenmakers, J. J. C. Arts. The available evidence on demineralised bone matrix in trauma and orthopaedic surgery: A systemati c review. 2017;6:423-432. DOI: 10.1302/2046-3758.67.BJR-2017-0027.R1.
本系统文献综述旨在评估市售脱矿骨基质（DBM）产品在创伤及骨科相关手术中应用的临床证据水平。
根据系统评价和Meta分析的首选报告项目声明，在两个可用数据库Embase和PubMed中，将总共17种DBM产品用作检索词。纳入所有报道DBM产品在创伤及骨科相关手术中临床应用的文章。
文献检索得到823篇手稿，其中64篇符合最终纳入标准。纳入的手稿包括四项随机对照试验（I级）、八项队列研究（III级）和49个病例系列（IV级）。未发现关于十种DBM产品的临床研究，且大多数DBM产品仅与其他移植材料联合使用。DBM产品在脊柱手术中研究最为广泛，显示有限的I级证据支持使用Grafton DBM（Osteotech公司，伊顿镇，新泽西州）作为后外侧腰椎融合手术中的骨移植扩展材料。DBM产品在创伤手术中未得到充分研究，主要显示IV级证据支持使用Allomatrix（Wright Medical公司，伦敦，英国）、DBX（DePuy Synthes公司，祖奇维尔，瑞士）、Grafton DBM或OrthoBlast（Citagenix公司，拉瓦尔，加拿大）作为骨移植扩展材料。
支持在创伤和骨科手术中使用DBM的临床证据水平有限，主要包括质量较差的回顾性病例系列。需要更多前瞻性随机对照试验来了解DBM在创伤和骨科手术中的临床效果和影响。J. van der Stok，K. A. Hartholt，D. A. L. Schoenmakers，J. J. C. Arts。创伤和骨科手术中脱矿骨基质的现有证据：一项系统评价。2017年；6：423 - 432。DOI：10.1302/2046 - 3758.67.BJR - 2017 - 0027.R1。
