Kohli Suraj, Schwenck Jonas, Barlow Ian
Department of Trauma and Orthopaedics, Dorset County Hospital NHS Foundation Trust, Williams Avenue, Dorchester, DT12JY, Dorset, UK.
Knee Surg Relat Res. 2022 Jun 13;34(1):27. doi: 10.1186/s43019-022-00155-1.
Meniscal injury is one of the most common indications for knee surgery. The advent of meniscal repair techniques has facilitated meniscal preservation in suitable cases. Meniscal substitution with scaffolds may be advantageous following partial meniscal resection. There are three main scaffolds in current clinical use; Collagen Meniscal Implant (CMI Stryker Corporation, Kalamazoo, MI, USA), Actifit (Actifit, Orteq Ltd, London, UK) and NUsurface (Active Implants, LLC). The purpose of this systematic review was to compare clinical outcomes and failure rates of patients who have had implantation with these meniscal scaffolds.
MEDLINE and EMBASE databases were searched for studies that included patients who had surgical implantation with Actifit or CMI. Eligibility criteria included papers that described both clinical outcomes and failure rates of these implants, a mean follow up of 5 years and studies published in English. A Google search was also performed to identify any grey literature.
Five Level IV studies were found for Actifit. One Level II, one Level III and four Level IV studies were found for the CMI implant. One Level II study was identified for the NUsurface scaffold with a follow-up 12 months and was included for completeness. Overall, 262 patients were treated with Actifit, 109 with CMI and 65 with NUsurface. Failure rates for Actifit were 18% (range 6.3-31.8%) with a mean follow up of 66.8 months, and for CMI 6.5% (range 0-11.8%) with a mean follow up of 97.1 months. The NUsurface failure rate was 16.9% at 12 months. Clinical outcomes such as VAS, Tegner and Lysholm scores improved significantly post-operatively. However, there was a high volume of concurrent procedures, such as anterior cruciate ligament reconstructions and high tibial osteotomies in each study group; 118 (45%) for Actifit and 53 (45%) for CMI.
The evidence for meniscal scaffold use is insufficient to suggest that they could potentially improve clinical outcomes in patients post-meniscal resection. This is largely due to the high proportion of concurrent procedures performed at index procedure for both CMI and Actifit. On the basis of current evidence, the use of meniscal scaffolds as a sole treatment for partial meniscal defects cannot be recommended, owing to the relatively high failure rate and paucity of clinical data.
半月板损伤是膝关节手术最常见的适应证之一。半月板修复技术的出现促进了在合适病例中保留半月板。半月板部分切除术后使用支架进行半月板置换可能具有优势。目前临床使用的主要有三种支架；胶原半月板植入物（CMI，史赛克公司，美国密歇根州卡拉马祖）、Actifit（Actifit，Orteq有限公司，英国伦敦）和NUsurface（Active Implants，有限责任公司）。本系统评价的目的是比较接受这些半月板支架植入患者的临床结局和失败率。
检索MEDLINE和EMBASE数据库，查找纳入接受Actifit或CMI手术植入患者的研究。纳入标准包括描述这些植入物临床结局和失败率、平均随访5年且以英文发表的论文。还进行了谷歌搜索以识别任何灰色文献。
发现5项关于Actifit的IV级研究。发现1项关于CMI植入物的II级研究、1项III级研究和4项IV级研究。识别出1项关于NUsurface支架的II级研究，随访12个月，为完整起见将其纳入。总体而言，262例患者接受了Actifit治疗，109例接受了CMI治疗，65例接受了NUsurface治疗。Actifit的失败率为18%（范围6.3%-31.8%），平均随访66.8个月，CMI的失败率为6.5%（范围0%-11.8%），平均随访97.1个月。NUsurface在12个月时的失败率为16.9%。术后VAS、Tegner和Lysholm评分等临床结局有显著改善。然而，每个研究组中同时进行的手术数量很多，如前交叉韧带重建和高位胫骨截骨术；Actifit组为118例（45%），CMI组为53例（45%）。
使用半月板支架的证据不足以表明它们可能改善半月板切除术后患者的临床结局。这主要是由于CMI和Actifit在初次手术时同时进行的手术比例很高。基于目前的证据，由于相对较高的失败率和临床数据匮乏，不建议将半月板支架作为半月板部分缺损的唯一治疗方法。
