PDF(Pubmed)
Abstract：
To date, insufficient investigation has been carried out on the biocompatibility of synthetic bioactive bone substitute materials after traumatically induced bone fractures in clinical conditions. This study encompasses the safety, resorption, healing process, and complications of surgical treatment. Our current hypothesis posits that calcium phosphate-based bone substitutes could improve bone healing. In this retrospective case-control study, over 290 patients who underwent surgical treatment for acute fractures were examined. Bone defects were augmented with calcium phosphate-based bone substitute material (CP) in comparison to with empty defect treatment (ED) between 2011 and 2018. A novel scoring system for fracture healing was introduced to assess bone healing in up to six radiological follow-up examinations. Furthermore, demographic data, concomitant diseases, and complications were subjected to analysis. Data analysis disclosed significantly fewer postoperative complications in the CP group relative to the ED group (p < 0.001). The CP group revealed decreased risks of experiencing complications (p < 0.001), arthrosis (p = 0.01), and neurological diseases (p < 0.001). The fracture edge, the fracture gap, and the articular surface were definably enhanced. Osteosynthesis and general bone density demonstrated similarity (p > 0.05). Subgroup analysis focusing on patients aged 64 years and older revealed a diminished complication incidence within the CP group (p = 0.025). Notably, the application of CP bone substitute materials showed discernible benefits in geriatric patients, evident by decreased rates of pseudarthrosis (p = 0.059). Intermediate follow-up evaluations disclosed marked enhancements in fracture gap, edge, and articular surface conditions through the utilization of CP-based substitutes (p < 0.05). In conclusion, calcium phosphate-based bone substitute materials assert their clinical integrity by demonstrating safety in clinical applications. They substantiate an accelerated early osseous healing trajectory while concurrently decreasing the severity of complications within the bone substitute cohort. In vivo advantages were demonstrated for CP bone graft substitutes.
摘要：
迄今为止,在临床条件下，对创伤引起的骨折后合成生物活性骨替代材料的生物相容性进行了不足的研究。这项研究包括安全性，再吸收,愈合过程，手术治疗的并发症。我们目前的假设假设是基于磷酸钙的骨替代物可以改善骨愈合。在这项回顾性病例对照研究中，超过290例接受手术治疗的急性骨折患者接受了检查。在2011年至2018年期间，与空缺损治疗（ED）相比，磷酸钙基骨替代材料（CP）增加了骨缺损。引入了一种新颖的骨折愈合评分系统，以在多达6次放射学随访检查中评估骨愈合。此外，人口统计数据，伴随疾病，并对并发症进行分析。数据分析显示，与ED组相比，CP组术后并发症明显减少（p<0.001）。CP组显示出现并发症的风险降低（p<0.001），关节病（p=0.01），和神经系统疾病（p<0.001）。骨折边缘，断裂间隙,并且关节表面被明确地增强。骨合成和一般骨密度显示相似性(p>0.05)。针对64岁及以上患者的亚组分析显示，CP组的并发症发生率降低（p=0.025）。值得注意的是,CP骨替代材料的应用在老年患者中显示出明显的益处，假关节发生率降低（p=0.059）。中间随访评估显示骨折间隙显著增强，边缘,和关节表面条件通过利用基于CP的替代品（p<0.05）。总之,基于磷酸钙的骨替代材料通过证明其在临床应用中的安全性来维护其临床完整性。他们证实了加速的早期骨愈合轨迹，同时降低了骨替代队列中并发症的严重程度。证明了CP骨移植替代品的体内优势。
