Evaluation of novel implant fixation technology with a new pre-clinical testing method

在英国，每年有超过30万个髋关节、膝盖、肩膀、脚踝或肘部装置被植入患者体内，用于治疗骨科疼痛、疾病和创伤。将这些植入物牢固地固定在骨骼上是手术成功的关键，但实现这一目标具有挑战性，因为骨骼是一种活组织，可以在手术后适应和变化。研究人员和行业努力开发新技术来改善固定，许多人的目标是通过使骨骼生长到植入物中来利用骨骼的活反应。这些新技术的设计意图总是善意的，但为了保护患者，有必要对他们进行临床前测试，以确认他们都是安全的，并实现他们的目标。然而，目前还缺乏合适的方法来测试这一点。传统的实验室临床前测试方法不允许使用活的骨骼样本进行测试，因此无法测量种植体骨生长/适应性。活体动物试验有伦理问题，费用昂贵，而且由于解剖差异和未知的负载而变得复杂。计算模型需要输入和验证数据，因此需要先前的实验室/动物/临床研究。另一种选择是临床试验，这是在患者身上进行有效的实验。它还经常需要数年或数十年的等待才能确定结果，因此只适合作为新产品开发的最后一步。这项研究项目旨在通过使用生物反应器系统来克服临床前测试的局限性，使种植固定技术能够在实验室中针对“活的”骨骼进行测试。开发的方法将通过成熟的临床技术进行验证，然后应用于临床前测试一种新的植入物固定概念。这项研究的长期目标是降低患者参加临床试验的风险，减少无效的活体动物测试的需要，并通过使固定技术针对体内性能进行优化来改进矫形植入物。

Every year in the UK, more than 300,000 hip, knee, shoulder, ankle or elbow devices are implanted into patients for the treatment of orthopaedic pain, disease and trauma. Secure fixation of these implants in bone is essential for the procedure's success, yet is challenging to achieve as bone is a living tissue that adapts and changes postoperatively.Researchers and industry strive to develop new technologies to improve fixation, with many aiming to take advantage of bone's living response by enabling it to grow into the implant. The design intent of these new technologies is always well-meaning, but to protect patients, it is necessary to pre-clinically test them, to confirm they are both safe and achieve their aim. However, there is a lack of appropriate methods for testing this.Traditional laboratory pre-clinical testing methods do not allow for testing with living bone samples and thus cannot measure implant bone ingrowth/adaptation. Live animal testing has ethical issues, is expensive and is complicated by anatomical differences and unknown loading. Computational models require input and validation data and so require a previous laboratory/animal/clinical study. The other alternative is clinical trial, which is effectively experimenting on patients. It also often requires years/decades of waiting to determine the outcome, and thus is only suitable as the final step of new product development.This research project aims to overcome limitations in pre-clinical testing by using a bioreactor system to enable implant fixation technologies to be tested against 'living' bone in the laboratory. The developed methods will be validated with established clinical technologies, before being applied to pre-clinically test a novel implant fixation concept.The long-term ambition for this research is to lower the risk for patients enrolling on clinical trials, reduce the need for ineffective live animal testing, and improve orthopaedic implants through enabling fixation technology to be optimised for in vivo performance.