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KENTFIELD, Calif., Nov. 07, 2023 (GLOBE NEWSWIRE) -- ZKR Orthopedics, Inc. a clinical stage medical device company, today announced successful completion of two-year follow up on subjects enrolled in the first-in-human clinical trial. The 18-patient trial conducted in the European Union was designed to evaluate the safety of the LIFT implant technology on patients with varying stages of patellofemoral cartilage degeneration.
加利福尼亚州肯特菲尔德,2023年11月7日(GLOBE NEWSWIRE)-临床阶段医疗器械公司ZKR Orthopedics,Inc。今天宣布成功完成为期两年的人体首次临床随访试验。在欧盟进行的18名患者试验旨在评估LIFT植入技术对髌股关节软骨退变不同阶段患者的安全性。
Further, the trial collected data related to pain, function, and radiographic imaging to evaluate the performance of the LIFT implant as a surgical alternative. Dr. Konrad Slynarski, the principal investigator for the trial, expressed his excitement about the results, saying, 'The success of this ZKR trial provides evidence that the patella LIFT implant appears to be a safe and effective surgical alternative for patients with patellofemoral cartilage degeneration and arthritis.
此外,该试验收集了与疼痛,功能和放射照相成像相关的数据,以评估LIFT植入物作为手术替代品的性能。该试验的首席研究员Konrad Slynarski博士对结果表示了兴奋,他说:“这项ZKR试验的成功提供了证据,证明髌骨提升植入物似乎是髌股关节患者安全有效的手术替代方案。软骨退化和关节炎。
Overall, there was a high level of patient satisfaction and improvements in both pain and function.' The first-in-human trial evaluated the performance of two implant geometries in a patient set which included patellofemoral cartilage degeneration ranging from moderate (Outerbridge Grade 2) to severe (bipolar osteoarthritis).
总体而言,患者满意度高,疼痛和功能均得到改善首次人体试验评估了患者组中两种植入物几何形状的表现,其中包括髌股关节软骨退变,范围从中度(Outerbridge 2级)到严重(双极性骨关节炎)。
A review of the data demonstrated an impressive reduction in pain (Visual Analog Scale) and improvement in function (Kujala Scale). No patients progressed to partial or total knee replacement. Additionally, there were no severe adverse events reported in the trial. The LIFT technology developed by Dr.
对数据的回顾表明疼痛显着减轻(视觉模拟评分)和功能改善(Kujala评分)。没有患者进展为部分或全膝关节置换术。此外,试验中没有报告严重不良事件。博士开发的升力技术。
Jeff Halbrecht is designed to elevate and realign the patella tendon to unload the patellofemoral compartment of the knee. Dr. Halbrecht stated, “The data from the pilot trial provides further evidence to our clinical hypothesis – unloading the patellofem.
杰夫·哈尔布雷希特(Jeff Halbrecht)旨在提升和重新调整髌骨肌腱,以卸下膝盖的髌股关节。Halbrecht博士说:“来自试验性试验的数据为我们的临床假设提供了进一步的证据-卸载髌骨。