Steadman Hawkins Clinic of the Carolinas, Prisma Health-Upstate, Greenville, SC, USA.
Steadman Hawkins Clinic of the Carolinas, Prisma Health-Upstate, Greenville, SC, USA.
J Shoulder Elbow Surg. 2021 Jul;30(7S):S27-S37. doi: 10.1016/j.jse.2021.04.003. Epub 2021 Apr 21.
Commercially available suture anchors for rotator cuff repairs can differ significantly in architecture and material. Clinical data on their osseous integration and its effect on patient-reported outcomes is scarce. Preclinical investigations indicated a higher rate of osseous integration for the open-architecture design of the Healicoil Regenesorb anchor than the closed-threaded design of the Twinfix (Smith & Nephew). The purpose of this study was to investigate these 2 anchors with different architecture and material to determine their effect on osseous integration and clinical outcomes after rotator cuff repair.
A prospective randomized controlled trial was performed from 2014 to 2019. Sixty-four patients (39 females, 25 males) with an average age of 58.7 years who underwent arthroscopic rotator cuff repair by one of 4 board-certified, fellowship-trained surgeons were randomized to receive Healicoil Regenesorb (PLGA/ß-TCP/Calcium Sulfate) or Twinfix Ultra HA (PLLA/HA) anchors. Thirty-two patients had Healicoil anchors implanted, and 32 patients had Twinfix anchors implanted. Of the 64 patients, 51 returned at 24 months for computed tomographic (CT) examination (25 Twinfix and 26 Healicoil) to determine osteointegration of the anchors. Patient-reported outcomes, including Penn Shoulder Score (PENN), Western Ontario Rotator Cuff Index, visual analog scale, EQ-5D, Single Assessment Numeric Evaluation, Global Rating of Change, were collected at baseline, 6 weeks, 3 months, 6 months, 12 months, and 24 months. Ultrasonography was used to assess rotator cuff integrity after 6 months. Two board-certified, fellowship-trained orthopedic surgeons, blinded to the type of anchors, analyzed the CT scans to assess the anchor osteointegration at 24 months using a previously published grading scale.
There were no differences in demographics, preoperative outcomes, or baseline characteristics such as tear size, number of anchors, Goutallier classification, or smoking status between groups. There was no difference in osseous integration between the 2 anchors at 24 months (P = .117). Eight patients had rotator cuff retears, of which 2 patients had Twinfix anchors and 6 patients had Healicoil anchors (P = .18). There were no statistically significant differences in patient-reported outcomes or complications between groups. The 2-year PENN scores were 89 with the Twinfix and 88 with Healicoil anchors (P = .55).
Despite differences in material and anchor architecture, the rate of healing and patient-reported outcomes were similar between the Twinfix and Healicoil anchor groups. The rate of osteointegration was the same at 2 years.
用于肩袖修复的市售缝合锚钉在结构和材料上可能有很大差异。关于其骨整合及其对患者报告结果影响的临床数据很少。临床前研究表明，与 Twinfix（Smith & Nephew）的封闭螺纹设计相比，Healicoil Regenesorb 锚钉的开放式结构设计具有更高的骨整合率。本研究旨在研究这两种具有不同结构和材料的锚钉，以确定它们对肩袖修复后骨整合和临床结果的影响。
这是一项从 2014 年至 2019 年进行的前瞻性随机对照试验。64 名（39 名女性，25 名男性）平均年龄为 58.7 岁的患者由 4 名经过董事会认证的、接受过奖学金培训的外科医生中的 1 名进行关节镜下肩袖修复，随机接受 Healicoil Regenesorb（PLGA/ß-TCP/Calcium Sulfate）或 Twinfix Ultra HA（PLLA/HA）锚钉。32 名患者植入 Healicoil 锚钉，32 名患者植入 Twinfix 锚钉。在 64 名患者中，有 51 名在 24 个月时返回进行计算机断层扫描（CT）检查（25 名 Twinfix 和 26 名 Healicoil）以确定锚钉的骨整合。在基线、6 周、3 个月、6 个月、12 个月和 24 个月时收集患者报告的结果，包括宾夕法尼亚肩评分（PENN）、安大略西部肩袖指数、视觉模拟量表、EQ-5D、单一评估数字评估、整体变化评级。在 6 个月时使用超声检查评估肩袖完整性。2 名经过董事会认证的、接受过奖学金培训的骨科医生对 CT 扫描进行分析，使用先前发表的分级量表评估 24 个月时的锚钉骨整合情况，他们对锚钉类型均不知情。
两组在人口统计学、术前结果或基线特征（如撕裂大小、锚钉数量、Goutallier 分类或吸烟状况）方面无差异。在 24 个月时，两种锚钉的骨整合无差异（P =.117）。8 名患者发生肩袖再撕裂，其中 2 名患者使用 Twinfix 锚钉，6 名患者使用 Healicoil 锚钉（P =.18）。两组患者的患者报告结果或并发症无统计学差异。2 年的 PENN 评分分别为 Twinfix 组 89 分和 Healicoil 组 88 分（P =.55）。
尽管材料和锚钉结构存在差异，但 Twinfix 和 Healicoil 锚钉组的愈合率和患者报告的结果相似。2 年时的骨整合率相同。
