Radboud University Medical Centre, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen, The Netherlands.
ATRO Medical BV, Liessentstraat 9-A, 5405 AH, Uden, The Netherlands.
Knee Surg Sports Traumatol Arthrosc. 2023 Jun;31(6):2526-2533. doi: 10.1007/s00167-022-07205-x. Epub 2022 Nov 7.
The purpose of this first-in-human study was to evaluate the effect of a polycarbonate anatomical meniscus prosthesis system, including the surgical procedure, on knee pain and describe potential adverse events in patients with post-meniscectomy pain syndrome.
Eleven patients with post-meniscectomy pain syndrome and limited underlying cartilage damage were enrolled in the study. Five received a medial polycarbonate urethane meniscus prosthesis which was clicked onto 2 titanium screws fixated at the native horn attachments on the tibia. The KOOS score was planned to be collected at baseline and at 3, 6, 12 and 24 months following the intervention including radiographs at 6, 12 and 24 months. MRI scans were repeated after 12 and 24 months.
The surgical technique to select an appropriately sized implant and correct positioning of the fixation screws and meniscus prosthesis onto the tibia was demonstrated to be feasible and reproducible. Inclusion stopped after 5 patients because of serious adverse device-related events. All patients reported knee joint stiffness and slight effusion in their knee at 6 months follow-up. In 3 patients the implant was removed because of implant failure and in 1 patient the implant was removed because of persistent pain and extension limitation. In none of the patients did the KOOS score improve in the first 6 months after surgery. However, in the patient who still has the implant in situ, PROMs started to improve 1 year after surgery and this improvement continued through 2 years of follow-up. The KOOS Pain, symptoms and ADL were close to the maximal 100 points. KOOS QoL and sport did improve but remained suboptimal.
This first version of the meniscus prosthesis led to impaired knee function and failed in four out of five patients. The patients where the prosthesis was removed were salvable and the PROMs returned to pre-study levels. The results in the patient where the device is still in place are promising.
Level II.
本项首次人体研究的目的是评估一种聚碳酸酯解剖半月板假体系统的效果，包括手术过程，以减轻膝关节疼痛，并描述半月板切除术后疼痛综合征患者的潜在不良事件。
本研究纳入了 11 例半月板切除术后疼痛综合征且软骨下基础损伤有限的患者。其中 5 例患者接受内侧聚碳酸酯氨酯半月板假体治疗，该假体通过固定在胫骨固有半月板附着处的 2 个钛螺钉固定。KOOS 评分计划在干预后 3、6、12 和 24 个月以及 6、12 和 24 个月的 X 线片时收集。在 12 个月和 24 个月时重复 MRI 扫描。
研究证明，选择适当大小的植入物并正确定位固定螺钉和半月板假体到胫骨的手术技术是可行且可重复的。由于严重的与器械相关的不良事件，在纳入 5 例患者后停止了研究。所有患者在 6 个月随访时均报告膝关节僵硬和轻微膝关节积液。在 3 例患者中，由于植入物失败而取出植入物，在 1 例患者中，由于持续疼痛和伸展受限而取出植入物。在手术后的前 6 个月，没有患者的 KOOS 评分得到改善。然而，在仍然存在植入物的患者中，术后 1 年 PROM 开始改善，这种改善持续到 2 年的随访期。KOOS 疼痛、症状和 ADL 接近最大的 100 分。KOOS QoL 和运动有所改善，但仍不理想。
第一代半月板假体导致膝关节功能受损，5 例患者中有 4 例失败。移除假体的患者可以被挽救，且 PROM 恢复到研究前的水平。假体仍在位的患者的结果有希望。
II 级。
