■研究表明,骶髂关节(SIJ)功能障碍是15%至30%报告的腰痛病例的原因。最近,由于安全性,人们对使用微创手术(MIS)进行SIJ融合越来越感兴趣.最初,为管理信息系统设计的设备旨在用于横向进近。已开发出一种用于后路的微创骶髂融合植入物,并在人类细胞所需的监管框架下进行临床使用。组织,或基于细胞或组织的产品(HCT/Ps)。
■多中心,prospective,在初步研究提供了支持安全性的初步数据后,启动了单臂研究,功效,这种微创骶髂后融合术LinQ同种异体移植植入物(NCT04423120)的耐久性和耐久性。之前报道了初步结果。完整参与者队列的最终结果在这里呈现。
■在2020年1月至2022年3月期间,在美国16个研究地点招募了一百五十九(159)名参与者。122名参与者被植入。在1个月的随访中,82名参与者满足复合响应者端点的所有标准,占研究队列的73.2%。这些结果在其余研究时间点中保持一致,为66.0%,74.4%,73.5%的参与者在3-被归类为响应者,6个月和12个月的随访,分别。VAS评分显著降低(p<0.0001),ODI评分显著提高(p<0.0001)。PROMIS-29的所有结构域也显著改善(所有p's<0.0001)。研究中只报告了一例与手术相关的严重不良事件。
■这些结果表明,后入路LinQ植入系统是12个月时骶髂关节功能障碍的安全有效治疗方法,与FDA批准的侧方入路报告的结果相比,结果是有利的。
UNASSIGNED: Research suggests that sacroiliac joint (SIJ) dysfunction is responsible for 15% to 30% of reported low back pain cases. Recently, there has been an increasing interest in SIJ fusion using minimally invasive surgery (MIS) due to safety. Initially, devices designed for MIS were intended for lateral approaches. A minimally invasive sacroiliac fusion implant for use with a posterior approach has been developed and is regulated for clinical use under the regulatory framework required for human cells, tissues, or cellular or tissue-based products (HCT/Ps).
UNASSIGNED: A multi-center, prospective, single-arm
study was launched after initial studies provided preliminary data to support safety, efficacy, and durability of this minimally invasive sacroiliac posterior fusion LinQ allograft implant (NCT04423120). Preliminary results were reported previously. Final results for the full participant cohort are presented here.
UNASSIGNED: One-hundred and fifty-nine (159) participants were enrolled across 16 investigational sites in the US between January 2020 and March 2022. One-hundred and twenty-two (122) participants were implanted. At the 1-month follow-up, 82 participants satisfied all criteria for the composite responder endpoint, representing 73.2% of the
study cohort. These results stayed consistent across the remaining
study timepoints with 66.0%, 74.4%, and 73.5% of participants classified as responders at the 3-, 6- and 12-month follow-up visits, respectively. VAS scores were significantly reduced (p < 0.0001) and ODI scores were significantly improved (p < 0.0001). All domains of the PROMIS-29 were also significantly improved (all p\'s <0.0001). Only one procedure-related serious AE was reported in the
study.
UNASSIGNED: These results suggest that the posterior approach LinQ Implant System is a safe and effective treatment for sacroiliac joint dysfunction at 12 months, with results that are favorable compared to outcomes reported for an FDA-cleared lateral approach.