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InSpace Implant Compared with Partial Repair for the Treatment of Full-Thickness Massive Rotator Cuff Tears: A Multicenter, Single-Blinded, Randomized Controlled Trial
The Journal of Bone & Joint Surgery ( IF 5.3 ) Pub Date : 2022-07-20 , DOI: 10.2106/jbjs.21.00667
Nikhil Verma 1 , Uma Srikumaran 2 , Colleen M Roden 3 , Edwin J Rogusky 4 , Peter Lapner 5 , Heather Neill 6 , Joseph A Abboud 7 ,
Affiliation  

Background: 

The purpose of this study was to prospectively evaluate the efficacy and safety of a subacromial balloon spacer (InSpace implant; Stryker) compared with arthroscopic partial repair in patients with irreparable, posterosuperior massive rotator cuff tears.

Methods: 

Patients ≥40 years of age with symptomatic, irreparable, posterosuperior, massive rotator cuff tears and an intact subscapularis who underwent failed nonoperative management were included in this randomized controlled trial comparing the InSpace implant with partial repair. Clinical outcome data were collected at baseline through a 24-month follow-up. The primary outcome was improvement in the American Shoulder and Elbow Surgeons (ASES) scores. The secondary outcomes included change from baseline in the Western Ontario Rotator Cuff (WORC) score, the visual analog scale (VAS) pain score, the Constant-Murley shoulder score, the EuroQol-5 Dimensions-5-Level (EQ-5D-5L) score, active range of motion, and operative time. Complications and reoperations for each group were also recorded.

Results: 

Twenty sites randomized 184 patients: 93 in the InSpace group and 91 in the partial repair group. Significant and clinically relevant improvements in the ASES score from baseline were noted in both groups at Month 12 and were maintained at Month 24. Overall, 83% of patients in the InSpace group and 81% of patients in the partial repair group achieved the ASES minimally clinically important difference threshold, and 82% of patients in the InSpace group and 79% of patients in the partial repair group achieved the substantial clinical benefit threshold. Forward elevation was significantly greater in the InSpace group compared with the partial repair group at Day 10 (p = 0.04), Week 6 (p = 0.0001), Month 12 (p = 0.005), and Month 24 (p = 0.003). The operative time was significantly shorter in the InSpace group (p < 0.0001). No device-related surgical complications were noted, and 4 reoperations after InSpace implantation and 3 reoperations after partial repair were required.

Conclusions: 

The InSpace implant is an appropriate alternative to partial repair in patients with irreparable posterosuperior massive rotator cuff tears and an intact subscapularis. Notable benefits include early functional recovery and pain relief combined with a shorter operative time.

Level of Evidence: 

Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.



中文翻译:

InSpace 植入物与部分修复治疗全层大面积肩袖撕裂的比较:一项多中心、单盲、随机对照试验

背景: 

本研究的目的是前瞻性评估肩峰下球囊垫片(InSpace 植入物;Stryker)与关节镜下部分修复无法修复的后上大块肩袖撕裂患者的疗效和安全性。

方法: 

年龄≥ 40 岁、有症状、无法修复、后上、大面积肩袖撕裂和完整的肩胛下肌并接受失败的非手术治疗的患者被纳入这项随机对照试验,比较 InSpace 植入物与部分修复。通过 24 个月的随访,在基线收集临床结果数据。主要结果是美国肩肘外科医生 (ASES) 评分的改善。次要结果包括西安大略肩袖 (WORC) 评分、视觉模拟量表 (VAS) 疼痛评分、Constant-Murley 肩部评分、EuroQol-5 Dimensions-5-Level (EQ-5D-5L) 相对于基线的变化) 得分、主动运动范围和手术时间。还记录了每组的并发症和再次手术。

结果: 

20 个地点随机分配了 184 名患者:InSpace 组 93 名,部分修复组 91 名。在第 12 个月时,两组均注意到 ASES 评分相对于基线有显着且临床相关的改善,并在第 24 个月保持不变。总体而言,InSpace 组中 83% 的患者和部分修复组中 81% 的患者达到了最低限度的 ASES临床重要差异阈值,InSpace 组 82% 的患者和部分修复组 79% 的患者达到实质性临床获益阈值。在第 10 天 (p = 0.04)、第 6 周 (p = 0.0001)、第 12 个月 (p = 0.005) 和第 24 个月 (p = 0.003),InSpace 组的前向抬高明显高于部分修复组。InSpace 组的手术时间明显缩短 (p < 0.0001)。

结论: 

InSpace 植入物是不可修复的后上大块肩袖撕裂和完整肩胛下肌的患者的部分修复的合适替代方案。显着的好处包括早期功能恢复和疼痛缓解以及较短的手术时间。

证据等级: 

治疗一级。有关证据等级的完整描述,请参阅作者须知。

更新日期:2022-07-20
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