Savarese Eugenio, Aicale Rocco, Romeo Rocco, Maffulli Nicola
Department of Orthopaedic and Trauma Surgery, Casa di Cura di Bernardini, Taranto, Italy.
Department of Orthopaedic and Trauma Surgery, Ospedale San Carlo, Via Potito Petrone, Potenza, Italy.
Knee Surg Sports Traumatol Arthrosc. 2025 May;33(5):1815-1825. doi: 10.1002/ksa.12445. Epub 2024 Aug 27.
The aim of the present study was to assess the effectiveness of balloon implantation in patients with irreparable supraspinatus tears alone or in combination with other rotator cuff (RC) tendon tears and the effect of several covariables, such as age, gender, status of the long head biceps, with or without tendon repair and regardless the number of tendon involved.
Patients enrolled from 'San Carlo' Hospital of Potenza (Italy, IT), from January 2012 to September 2014, underwent arthroscopic implantation of shoulder balloon by a single surgeon, and followed for 3 years. The American Shoulder and Elbow Surgeons (ASES) and Constant score (CS) were administered pre-, post-operatively at 12 months, and then annually. Patients were classified on the basis of the number of tendons involved in the tears and treatment performed, considering the reparability of the tendons themselves. Gleno-humeral joint osteoarthrosis (OA) was evaluated through shoulder radiographs and classified according to the Samilson-Prieto classification, at the first examination and at the final follow-up. Statistical improvements were evaluated using a variance model (least-squares means) and a T distribution test for the evaluation between different treatment groups.
A total of 61 procedures were performed, and eight patients were lost during follow-up. The mean baseline CS was 30.2 ± 15.4 with statistically significant improvement, respectively, at 1-, 2- and 3-year follow-up to 69.3 ± 4.2, 74.6 ± 3.6 and 69.7 ± 5.1 respectively. ASES score at baseline was 22.5 ± 10.9, with a statistically significant improvement to 69.7 ± 9.2, 68 ± 17.8 and 71.2 ± 16.6 at 1-, 2- and 3-year follow-up, respectively. Tenotomy or absence of long head biceps at presentation did not influence results (n.s.), with no difference according to gender and age. At final follow-up, 24 patients (43.9%) showed progression of glenohumeral OA. One patient required secondary surgery for shoulder replacement after 18 months for persistent pain and one patient required implant removal following post-operative laser treatment.
Arthroscopic rotator cuff tears repair with subacromial spacer balloon implantation showed statistically significant clinical and functional improvement at 3-year follow-up. Patients treated with combined partial repair and subacromial spacer balloon implantation experienced good results independent of gender, age, type of tear and long-head biceps tendon status. The risks related to this procedure appear to be minimal.
Level IV.
本研究旨在评估单独对不可修复的冈上肌撕裂患者或联合其他肩袖（RC）肌腱撕裂患者进行球囊植入的有效性，以及年龄、性别、肱二头肌长头状况等多个协变量的影响，无论是否进行肌腱修复以及涉及的肌腱数量。
2012年1月至2014年9月期间，从意大利波坦察的“圣卡罗”医院招募患者，由一名外科医生对其进行肩关节球囊关节镜植入，并随访3年。术前、术后12个月以及随后每年进行美国肩肘外科医师（ASES）评分和常数评分（CS）。根据撕裂涉及的肌腱数量和所进行的治疗，考虑肌腱本身的可修复性对患者进行分类。通过肩部X线片评估盂肱关节骨关节炎（OA），并在首次检查和最终随访时根据萨米尔森 - 普列托分类法进行分类。使用方差模型（最小二乘均值）和T分布检验评估不同治疗组之间的统计学改善情况。
共进行了61例手术，8例患者在随访期间失访。平均基线CS为30.2±15.4，在1年、2年和3年随访时分别有统计学显著改善，达到69.3±4.2、74.6±3.6和69.7±5.1。基线时ASES评分为22.5±10.9，在1年、2年和3年随访时分别有统计学显著改善，达到69.7±9.2、68±17.8和71.2±16.6。就诊时肱二头肌长头腱切断或缺失对结果无影响（无统计学意义），按性别和年龄无差异。在最终随访时，24例患者（43.9%）出现盂肱关节OA进展。1例患者在18个月后因持续疼痛需要进行二次肩关节置换手术，1例患者在术后激光治疗后需要取出植入物。
在3年随访时，关节镜下肩袖撕裂修复联合肩峰下间隔球囊植入显示出统计学显著的临床和功能改善。接受部分修复联合肩峰下间隔球囊植入治疗的患者，无论性别、年龄、撕裂类型和肱二头肌长头腱状况如何，均取得了良好的效果。该手术相关风险似乎最小。
IV级。
