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首页> 外文期刊>Orthopaedic Journal of Sports Medicine >Subacromial Balloon Spacer versus Partial Repair for Massive Rotator Cuff Tears: A Prospective, Randomized, Multi-center Trial
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Subacromial Balloon Spacer versus Partial Repair for Massive Rotator Cuff Tears: A Prospective, Randomized, Multi-center Trial

机译：Subacromial Balloon Spacer与群式旋转袖口撕裂的部分修复：预期，随机，多中心试验

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摘要

Objectives: Despite various treatment options, the successful management of irreparable, massive rotator cuff tears (MRCTs) remains challenging. Implantation of a biodegradable subacromial balloon spacer (InSpace ~(TM) system; OrthoSpace, Caesarea, Isreal) has gained considerable interest for the treatment of MCRTs due to its ability to effectively recenter the humeral head within the glenoid. Despite promising results, investigations examining outcomes following balloon spacer implantation are limited to small case series and short-term prospective trials without comparison to other surgical modalities. The purpose of the present investigation was to prospectively evaluate the safety and efficacy of the arthroscopically deployed, subacromial spacer balloon compared to partial rotator cuff repair in patients with MRCTs at 24 month follow up. Methods: A non-inferiority, prospective, single-blinded, multicenter, randomized, controlled, pivotal study was conducted to compare the outcomes of arthroscopic subacromial balloon spacer implantation to partial repair in the treatment of MRCTs. Patients ≥ 40 years of age with symptomatic full thickness MRCTs (tears ≥ 5 cm or ≥ 2 tendons) that had failed non-operative management were included. Clinical outcome data, derived from subjective questionnaires and physical examination, were collected at baseline and follow-up intervals at Day 10, Week 6, Month 3, 6, 12 and 24. Postoperative magnetic resonance imaging (MRI) scans were obtained at 6 weeks and 12 months. The primary composite effectiveness endpoint was defined as achievement of the minimal clinically important difference (MCID) for the Western Ontario Rotator Cuff (WORC) score (275 points) and American Shoulder and Elbow Society (ASES) score (6.4 points) by week 6 and maintenance at month 12 without subsequent secondary surgical intervention (SSSI) or serious adverse device effects (SADEs). Secondary effectiveness endpoints included changes in individual and composite clinical outcome scores relative to baseline in addition to MRI findings. Intention-to-treat (ITT), per-protocol (PP), and safety analyses were performed separately. Results: A total of 20 sites were enrolled in the investigation. One hundred, eighty-four patients were randomized into the clinical study (n= 93 balloon spacer; n= 91 partial repair) and included in the safety population, of which 183 patients were included in the ITT analysis (n=93 balloon spacer; n= 90 partial repair) and 176 in the PP analysis (n= 88 balloon spacer; n= 88 partial repair). No significant difference in demographic characteristics based on mean age, sex, race or body mass index were appreciated between groups. Mean procedure duration was 44.6 ± 16.9 minutes for the balloon spacer group and 71.2 ± 30.1 minutes for the partial repair group. Significant improvement over time relative to baseline was observed in all WORC (Fig. 1) and ASES (Fig. 2) scores in both groups. The magnitude of improvement for subjects in the balloon spacer group was the same or better than for subjects in the partial repair group at 12 and 24 month follow up. At 12 months, 51% (n=45 of 88) of patients in the balloon spacer group and 35 patients 40% (n= 35 of 88) in the partial repair group had reached and maintained the primary composite endpoint, meeting the noninferiority criteria (non-inferiority margin 10%; p = 0.0049) and corresponding to an 11.4% mean advantage for the spacer implant group. Non-inferiority was similarly confirmed in the ITT population (p=0.0089). SSSI occurred in 6 subjects (n=3 balloon spacer; n=3 partial repair), with two subjects in each group requiring reverse shoulder arthroplasty and one subject in each group undergoing shoulder arthroscopy. Conclusions: Use of the balloon spacer was found to produce non-inferior outcomes when compared to partial rotator cuff repair for patients with MRCTs at 24 month follow up. Outcomes following balloon spacer device placement met non-inferiority criteria when compared to the partial repair group based on primary composite endpoints.
机译：目的：尽管各种治疗方案，成功管理无法弥补，巨大的旋转器袖口（MRCTS）仍然挑战。植入可生物降解的子谚语气球间隔物（Inspace〜（TM）系统; Orthospace，Caesarea，Isreal）由于其能够有效地垂耳地的肱骨头部的能力而获得了相当大的兴趣。尽管结果有前途的结果，但研究气球间隔植入后的结果的调查仅限于小型案例系列和短期前瞻性试验，而无需与其他手术方式相比。目前调查的目的是，与24个月的MRCTS患者的部分旋转器袖带修复相比，预期评估关节镜下部署的亚克明的亚克明的亚克明间隔气囊的安全性和有效性。方法：进行非劣势，前瞻性，单迷目，多中心，随机，对照，枢轴研究，以比较关节镜亚群气球间隔物植入治疗MRCTS的局部修复的结果。患者≥40岁，患有失败的非操作管理失败的症状全厚度MRCTS（撕裂≥5厘米或≥2个肌腱）。来自主观问卷和体检的临床结果数据在第10天，第6周，第3周，第3,6,12和24天以基线和后续间隔收集。术后磁共振成像（MRI）扫描在6周内获得12个月。主要复合有效性终点被定义为在安大略省旋转器袖口（WORC）评分（275分）和美国肩部和肘部社会（ASES）评分（6.4分）的最小临床重要差异（MCID）的成就。在没有随后的二级外科干预（SSSI）或严重不良器件影响（悲伤）的情况下维护。除MRI调查结果外，二次有效性终点包括相对于基线的个体和复合临床结果评分的变化。有意治疗（ITT），单方案（PP）和安全分析是单独进行的。结果：在调查中共有20个网站。一百八十四名患者随机分为临床研究（n = 93气球间隔物; n = 91部分修复），包括在安全群体中，其中183名患者被列入ITT分析（n = 93个气球间隔物; n = 90部分修复）和176在PP分析中（n = 88气球间隔物; n = 88部分修复）。基于平均年龄，性别，种族或体重指数之间的人口特征没有显着差异。球囊间隔基团的平均程序持续时间为44.6±16.9分钟，部分修复组71.2±30.1分钟。在两个组中的所有情况下都观察到相对于基线相对于基线的显着改善。球囊间隔基团中受试者的改善的程度相同或更好地在12个月和24个月的部分修复组中的受试者进行跟进。在12个月内，球囊间隔组的51％（N = 45 of 88）和部分修复组中的35例患者40％（n = 35 of 88）达到并维持了初级复合终点，满足非事实体标准（非较低率裕度10％; p = 0.0049），对应于间隔植入物组的11.4％的平均优势。 ITT群体中类似地确认了非劣等（P = 0.0089）。 SSSI发生在6个受试者（n = 3气球间隔; n = 3部分修复）中，每组中的两个受试者需要反向肩部关节置换术和在肩部关节镜接受肩部关节镜的每个组中的一个受试者。结论：与患有MRCTS在24个月的MRCTS的患者跟进时，发现使用气球间隔物的使用产生非劣质结果。与基于主复合端点的部分修复组相比，在球囊间隔装置放置后的结果达到非劣级度标准。

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