An early health technology assessment (HTA) study was performed to assess the need for developing a new bioabsorbable implant for the treatment of specific orthopedic injuries. The Anterior Cruciate Ligament Reconstruction (ACLR) procedure was selected based on the need and potential impact of bioabsorbable implants in the treatment of ACL injuries. The economic model considers the possible health events after an ACLR (failures and other complications such as stiffness and pain). A decision tree approach was used, and several sensitivity analyses were performed using a Monte Carlo simulation. A cost estimating model was applied comparatively for currently available metal and bioabsorbable implants against a potential new bioabsorbable implant with improved performance. A reduction in stiffness and pain symptoms were considered as targets for these new implants performance, with reduced inflammation resulting from the use of materials with appropriate biological and mechanical properties.

The current study estimates that, under the assumptions made, the introduction of a new bioabsorbable implant in ACLR surgeries may generate yearly cost savings. The model estimates positive cost-benefits of the new implant when it reduces the probability of failure by more than 30%, or reduces at least 14% the probability of complications of an inflammatory nature. The development of a new bioabsorbable orthopedic implant for ACLR is encouraged by this study identifying the need for new bioabsorbable implants with improved biological and mechanical performance.

The results of this early HTA have made it possible to anticipate design needs and objectives for the research and development of new orthopedic bioabsorbable implants.

进行了一项早期健康技术评估 (HTA) 研究，以评估开发用于治疗特定骨科损伤的新型生物可吸收植入物的必要性。根据生物可吸收植入物在治疗 ACL 损伤中的需求和潜在影响，选择了前交叉韧带重建 (ACLR) 程序。经济模型考虑了 ACLR 后可能发生的健康事件（失败和其他并发症，如僵硬和疼痛）。使用了决策树方法，并使用蒙特卡罗模拟进行了若干敏感性分析。成本估算模型被比较应用于当前可用的金属和生物可吸收植入物与具有改进性能的潜在新型生物可吸收植入物。

目前的研究估计，根据所做的假设，在 ACLR 手术中引入新的生物可吸收植入物可能会每年节省成本。当新植入物将失败概率降低 30% 以上或炎症性质并发症的概率降低至少 14% 时，该模型估计了新植入物的正成本效益。这项研究确定了对具有改进生物和机械性能的新型生物可吸收植入物的需求，这鼓励了开发用于 ACLR 的新型生物可吸收骨科植入物。

这一早期 HTA 的结果使得预测新的骨科生物可吸收植入物的研究和开发的设计需求和目标成为可能。