Institute of Drug Research, School of Pharmacy-Faculty of Medicine, The Hebrew University of Jerusalem, Jerusalem, 91120, Israel.
Ortho-Space Ltd., Caesarea, Israel.
J Mech Behav Biomed Mater. 2019 Dec;100:103404. doi: 10.1016/j.jmbbm.2019.103404. Epub 2019 Aug 27.
Rotator cuff tendons injuries occurs as a result of trauma, e.g. due to falling, mechanical injuries and frequent overhead activity and as natural degenerative tears in elderly people. Biodegradable balloon shaped spacer of Poly-(L-lactide-co-ε-caprolactone) (PLCL) are applied in the treatment of these injuries. This type of treatment involves insertion of inflated biodegradable implant into the tissues of the damaged region in the shoulder to avoid shoulder impingement and reduce friction between the acromion and the humeral head and propagation of inflammation. The implant must maintain integrity under significant mechanical loading in order to remain effective. However, with time, the implant is exposed to the risk of failure due to the high pressure caused by the muscular motion and the friction with the bones. We report in this study the limits of the mechanical stability of the PLCL balloon shape spacer (implant) under prolonged cyclic loading, so as to be able to predict their physical stability in vivo. We have demonstrated in an in vitro settings that the implant withstands fatigue cycles for significantly longer than 8 weeks, which provides sufficient time window for patients to perform substantial rehabilitation and recover from an injury. The data presented herein is expected to assist medical practitioners in safety and efficacy measurements and assessment following spacer implantation.
肩袖肌腱损伤是由于创伤引起的，例如由于跌倒、机械损伤和频繁的头顶活动以及老年人的自然退行性撕裂。可生物降解的聚（L-丙交酯-co-ε-己内酯）（PLCL）气球形间隔物被应用于这些损伤的治疗。这种治疗方法涉及将充气的可生物降解植入物插入肩部受损区域的组织中，以避免肩部撞击，减少肩峰和肱骨头之间的摩擦以及炎症的传播。为了保持有效性，植入物必须在承受显著机械载荷下保持完整性。然而，随着时间的推移，由于肌肉运动和与骨骼的摩擦产生的高压，植入物面临失效的风险。我们在这项研究中报告了在长时间周期性加载下 PLCL 气球形间隔物（植入物）的机械稳定性极限，以便能够预测其在体内的物理稳定性。我们已经在体外环境中证明，植入物能够承受疲劳循环的时间明显长于 8 周，这为患者提供了足够的时间窗口来进行大量的康复治疗并从损伤中恢复。本文提供的数据有望帮助医疗从业者进行安全性和有效性测量和评估，以确保间隔物植入后的安全性和有效性。
