Lind Martin, Nielsen Torsten, Sørensen Ole Gade, Mygind-Klavsen Bjarne, Faunø Peter, Leake-Gardner Stacy
Department of Orthopedics, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N, Denmark.
Smith & Nephew Clinical, Scientific & Medical Affairs, Global R&D, 7135 Goodlett Farms Parkway, Cordova, TN, 38016, USA.
J Exp Orthop. 2020 Sep 18;7(1):68. doi: 10.1186/s40634-020-00285-z.
Open or fenestrated interference screw design that allow bone ingrowth is a concept for improved bone healing to softtissue graft and bone filling in bone tunnels after anterior cruciate ligament reconstruction (ACLR) The aim of the current study was to assess CT scanning evaluated bone ingrowth into an open architecture interference screws in the tibial tunnel of patients undergoing ACL with soft tissue grafts. It was hypothesized that open architecture interference screws would stimulate bone ingrowth into the screw cavities.
Twelve patients requiring ACLR were included. They underwent arthroscopic ACLR with semitendinosus-/gracilis tendon graft and an open architecture polyetheretherketone (PEEK) interference screw. The patients were scanned with a multi-slice CT scanner two weeks, six and twelve months postoperatively. On CT reconstruction slices bone ingrowth into the screw was measured. Subjective and objective clinical outcome international knee documentation committee score and instrumented knee laxity determination were collected.
At six months no implants demonstrated more than 10% bone ingrowth. At twelve months 42% (5/12) implants had more than 10% bone ingrowth (p = 0.009). The average bone filling into the screws was 7.7%. There was no tunnel widening or cyst formation seen in relation to any of the implants. Subjective IKDC score improved significantly from 50.6 baseline to 80.1 at 24 month follow-up. Preoperative side-to-side knee laxity improved from 3.7 (2.1) to 1.4 (1.2) mm at twelve months. There were no serious adverse events in relation to the new open architecture thread PEEK interference screw during or after hamstring ACL reconstruction.
The present study demonstrated that open architecture thread PEEK interference screw can stimulate bone ingrowth into the screws after soft tissue ACL reconstruction with at 12 months with an average bone filling into screws was 7.7%. Knee stability, functional, subjective and objective outcomes were similar to large volume ACL outcome studies.
The study was registered at ClinicalTrials # NCT02382341 . 12-09-2014.
IV.
允许骨长入的开放式或带孔干涉螺钉设计是一种改善前交叉韧带重建（ACLR）后骨隧道内软组织移植和骨填充的骨愈合的概念。本研究的目的是评估CT扫描对接受软组织移植的ACL患者胫骨隧道内开放式结构干涉螺钉的骨长入情况。假设开放式结构干涉螺钉会刺激骨长入螺钉腔。
纳入12例需要进行ACLR的患者。他们接受了关节镜下ACLR，使用半腱肌/股薄肌腱移植和开放式聚醚醚酮（PEEK）干涉螺钉。术后2周、6个月和12个月对患者进行多层CT扫描。在CT重建切片上测量螺钉内的骨长入情况。收集主观和客观临床结果，国际膝关节文献委员会评分和仪器测量的膝关节松弛度测定结果。
6个月时，没有植入物显示骨长入超过10%。12个月时，42%（5/12）的植入物骨长入超过10%（p = 0.009）。螺钉内的平均骨填充率为7.7%。与任何植入物相关均未见隧道增宽或囊肿形成。主观IKDC评分从基线时的50.6显著提高到24个月随访时的80.1。术前双侧膝关节松弛度在12个月时从3.7（2.1）mm改善到1.4（1.2）mm。在腘绳肌ACL重建期间或之后，与新型开放式结构螺纹PEEK干涉螺钉相关的严重不良事件。
本研究表明，开放式结构螺纹PEEK干涉螺钉可在软组织ACL重建后12个月刺激骨长入螺钉，螺钉内的平均骨填充率为7.7%。膝关节稳定性、功能、主观和客观结果与大量ACL结果研究相似。
该研究于2014年9月12日在ClinicalTrials # NCT02382341注册。
IV级。
