Chung Seok Won, Oh Kyung-Soo, Kang Sung Jin, Yoon Jong Pil, Kim Joon Yub
Department of Orthopaedic Surgery, Konkuk University School of Medicine, Seoul, Korea.
Department of Orthopaedic Surgery, Kyungpook University College of Medicine, Daegu, Korea.
Clin Shoulder Elb. 2018 Mar 1;21(1):22-29. doi: 10.5397/cise.2018.21.1.22. eCollection 2018 Mar.
This study is performed to evaluate anchor-related outcomes and complications after arthroscopic rotator cuff repair using 30% β-tricalcium phosphate (β-TCP) with 70% poly lactic-co-glycolic acid (PLGA) biocomposite suture anchors.
A total of 78 patients (mean age, 61.3 ± 6.9 years) who underwent arthroscopic medium-to-large full-thickness rotator cuff tear repair were enrolled. The technique employed 30% β-TCP with 70% PLGA biocomposite suture anchors at the medial row (38 patients, Healix BR anchor [Healix group]; 40 patients, Fixone anchor B [Fixone group]). The radiologic outcomes (including perianchor cyst formation or bone substitution) and anatomical outcomes of the healing failure rate were evaluated using magnetic resonance imaging at least 6 months after surgery, the pain visual analogue scale at 3, 6 months, and final follow-up visit, and American Shoulder and Elbow Surgeons scores at least 1 year postoperatively. Anchor-related complications were also evaluated.
The perianchor cyst formation incidence was similar for both groups (60.5%, Healix group; 60.0%, Fixone group; =0.967), although severe perianchor cyst incidence was slightly lower in the Fixone group (15.0%) than in the Healix group (21.1%). There was no occurrence of anchor absorption and bone substitution. No differences were observed in the healing failure rate (13.2%, Healix group; 15.0%, Fixone group; =0.815) and functional outcome between groups (all >0.05). Anchor breakage occurred in 5 patients (2 Healix anchors and 3 Fixone anchors); however, there were no major anchor-related complications in either group.
No differences were observed in the clinical outcomes of the Healix and Fixone groups, neither were there any accompanying major anchor-related complications.
本研究旨在评估使用含30%β-磷酸三钙(β-TCP)和70%聚乳酸-乙醇酸共聚物(PLGA)的生物复合材料缝线锚钉进行关节镜下肩袖修补术后与锚钉相关的结果及并发症。
共纳入78例接受关节镜下中到大的全层肩袖撕裂修补术的患者(平均年龄61.3±6.9岁)。该技术在内排使用含30%β-TCP和70%PLGA的生物复合材料缝线锚钉(38例患者使用Healix BR锚钉[Healix组];40例患者使用Fixone锚钉B[Fixone组])。术后至少6个月使用磁共振成像评估放射学结果(包括锚钉周围囊肿形成或骨替代)以及愈合失败率的解剖学结果,在3个月、6个月及最终随访时评估疼痛视觉模拟量表,术后至少1年评估美国肩肘外科医师评分。还评估了与锚钉相关的并发症。
两组的锚钉周围囊肿形成发生率相似(Healix组为60.5%,Fixone组为60.0%;P=0.967),尽管Fixone组严重锚钉周围囊肿发生率(15.0%)略低于Healix组(21.1%)。未发生锚钉吸收和骨替代。两组之间在愈合失败率(Healix组为13.2%,Fixone组为15.0%;P=0.815)和功能结果方面均未观察到差异(均P>0.05)。5例患者发生锚钉断裂(2例Healix锚钉和3例Fixone锚钉);然而,两组均未出现与锚钉相关的重大并发症。
Healix组和Fixone组的临床结果未观察到差异,也未出现任何与之相关的重大锚钉并发症。