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、膝关节、肩部、踝关节或肘部设备被植入患者体内，用于治疗骨科疼痛、疾病和创伤。这些植入物在骨内的安全固定对手术的成功至关重要，但由于骨是一种活组织，术后会适应和改变，因此实现这一目标具有挑战性。研究人员和工业界都在努力开发新技术来改善固定，许多人的目标是利用骨骼的活性反应，使其能够生长到植入物中。这些新技术的设计意图总是善意的，但为了保护患者，有必要对它们进行临床前测试，以确认它们既安全又能达到目的。然而，缺乏适当的测试方法。传统的实验室临床前测试方法不允许对活骨样本进行测试，因此无法测量种植体骨的生长/适应。活体动物试验存在伦理问题，价格昂贵，并且由于解剖差异和未知负荷而变得复杂。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，即在患者身上进行有效的实验。它也经常需要数年/数十年的等待来确定结果，因此只适合作为新产品开发的最后一步。该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，从而使植入物固定技术能够在实验室中针对“活”骨进行测试。开发的方法将与已建立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，减少对无效活体动物试验的需求，并通过优化固定技术来改善骨科植入物的体内性能。

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.