Iundusi Riccardo, Gasbarra Elena, D'Arienzo Michele, Piccioli Andrea, Tarantino Umberto
Department of Orthopedics and Traumatology, University "Tor Vergata", "Policlinico Tor Vergata" Foundation, Viale Oxford 81, 00133, Rome, Italy.
Orthopaedic Department, University of Palermo, Via del Vespro, 90100, Palermo, Italy.
BMC Musculoskelet Disord. 2015 May 13;16:115. doi: 10.1186/s12891-015-0574-6.
Reduction of tibial plateau fractures and maintain a level of well aligned congruent joint is key to a satisfactory clinical outcome and is important for the return to pre-trauma level of activity. Stable internal fixation support early mobility and weight bearing. The augmentation with bone graft substitute is often required to support the fixation to mantain reduction. For these reasons there has been development of novel bone graft substitutes for trauma applications and in particular synthetic materials based on calcium phosphates and/or apatite combined with calcium sulfates. Injectable bone substitutes can optimize the filling of irregular bone defects. The purpose of this study was to assess the potential of a novel injectable bone substitute CERAMENT™|BONE VOID FILLER in supporting the initial reduction and preserving alignment of the joint surface until fracture healing.
From June 2010 through May 2011 adult patients presenting with acute, closed and unstable tibial plateau fractures which required both grafting and internal fixation, were included in a prospective study with percutaneous or open reduction and internal fixation (ORIF) augmented with an injectable ceramic biphasic bone substitute CERAMENT™|BONE VOID FILLER (BONESUPPORT™, Lund, Sweden) to fill residual voids. Clinical follow up was performed at 1, 3, 9 and 12 months and any subsequent year; including radiographic analysis and Rasmussen system for knee functional grading.
Twenty four patients, balanced male-to-female, with a mean age of 47 years, were included and followed with an average of 44 months (range 41-52 months). Both Schatzker and Müller classifications were used and was type II or 41-B3 in 7 patients, type III or 41-B2 in 12 patients, type IV or 41-C1 in 2 patients and type VI or 41-C3 in 3 patients, respectively. The joint alignement was satisfactory and manteined within a range of 2 mm, with an average of 1.18 mm. The mean Rasmussen knee function score was 26.5, with 14 patients having an excellent result and the remaining 10 with a good result.
It can be concluded that radiological and clinical outcome was satisfactory and obtained in all cases without complications. This injectable novel biphasic hydroxyapatite and calcium sulfate ceramic material is a valuable armamentarium in the treatment of trauma where bone graft is required.
胫骨平台骨折的复位并维持关节面良好对齐是获得满意临床结果的关键，对于恢复创伤前的活动水平也很重要。稳定的内固定有助于早期活动和负重。通常需要使用骨移植替代物来加强固定以维持复位。因此，已经开发出用于创伤应用的新型骨移植替代物，特别是基于磷酸钙和/或磷灰石与硫酸钙结合的合成材料。可注射骨替代物可以优化不规则骨缺损的填充。本研究的目的是评估一种新型可注射骨替代物CERAMENT™|骨缺损填充剂在支持初始复位并在骨折愈合前保持关节面 alignment 的潜力。
从2010年6月至2011年5月，纳入患有急性、闭合性和不稳定胫骨平台骨折且需要植骨和内固定的成年患者，进行一项前瞻性研究，采用经皮或切开复位内固定（ORIF），并用可注射双相陶瓷骨替代物CERAMENT™|骨缺损填充剂（BONESUPPORT™，瑞典隆德）填充残余骨缺损。在1、3、9和12个月以及随后的任何一年进行临床随访；包括影像学分析和膝关节功能分级的拉斯穆森系统。
纳入24例患者，男女比例均衡，平均年龄47岁，平均随访44个月（范围41 - 52个月）。同时使用了沙茨克和米勒分类法，其中7例为II型或41 - B3型，12例为III型或41 - B2型，2例为IV型或41 - C1型，3例为VI型或41 - C3型。关节 alignment 令人满意，维持在2毫米范围内，平均为1.18毫米。拉斯穆森膝关节功能平均评分为26.5分，14例结果优秀，其余10例结果良好。
可以得出结论，所有病例的放射学和临床结果均令人满意且无并发症。这种可注射的新型双相羟基磷灰石和硫酸钙陶瓷材料是治疗需要骨移植的创伤的有价值的手段。
