Leeds Teaching Hospitals NHS Trust, Chapel Allerton Hospital, Chapeltown Road, Leeds, LS7 4SA, UK.
NIHR Leeds Biomedical Research Centre, Leeds, UK.
BMC Musculoskelet Disord. 2020 Apr 7;21(1):213. doi: 10.1186/s12891-020-03227-z.
The aim of this study was to explore the feasibility of using a non-absorbable biocompatible polyester patch to augment open repair of massive rotator cuff tears (Patch group) and compare outcomes with other treatment options (Non-patch group).
Participants referred to orthopaedic clinics for rotator cuff surgery were recruited. Choice of intervention (Patch or Non-patch) was based on patient preference and intra-operative findings. Oxford Shoulder Score (OSS), Shoulder Pain and Disability Index (SPADI), and Constant score were completed at baseline and 6 months. Shoulder MRI was performed at baseline and 6 months to assess fat fraction and Goutallier classification pre- and post- treatment. Feasibility outcomes (including retention, consent and missing data) were assessed.
Sixty-eight participants (29 in the Patch group, 39 in Non-patch group) were included (mean age 65.3 years). Conversion to consent (92.6%), missing data (0% at baseline), and attrition rate (16%) were deemed successful feasibility endpoints. There was significant improvement in the Patch group compared to Non-patch at 6 months in OSS (difference in medians 9.76 (95% CI 2.25, 17.29) and SPADI: 22.97 (95% CI 3.02, 42.92), with no substantive differences in Constant score. The patch group had a higher proportion of participants improving greater than MCID for OSS (78% vs 62%) and SPADI (63% vs 50%) respectively. Analysis of the 48 paired MRIs demonstrated a slight increase in the fat fraction for supraspinatus (53 to 55%), and infraspinatus (26 to 29%) at 6 months. These differences were similar and in the same direction when the participants were analysed by treatment group. The Goutallier score remained the same or worsened one grade in both groups equally.
This study indicates that a definitive clinical trial investigating the use of a non-absorbable patch to augment repair of massive rotator cuff tears is feasible. In such patients, the patch has the potential to improve shoulder symptoms at 6 months.
ISRCTN, ISRCTN79844053, Registered 15th October 2014 (retrospectively registered).
本研究旨在探讨使用不可吸收的生物相容性聚酯补片增强开放性巨大肩袖撕裂修复的可行性，并与其他治疗选择（非补片组）进行比较。
招募因肩袖手术而到骨科诊所就诊的参与者。干预措施的选择（补片或非补片）基于患者的偏好和术中发现。基线和 6 个月时完成牛津肩评分（OSS）、肩痛和残疾指数（SPADI）和 Constant 评分。基线和 6 个月时进行肩部 MRI 检查，以评估治疗前后的脂肪分数和 Goutallier 分级。评估可行性结果（包括保留率、同意率和缺失数据）。
纳入 68 名参与者（补片组 29 名，非补片组 39 名；平均年龄 65.3 岁）。转换为同意率（92.6%）、缺失数据率（基线时为 0%）和流失率（16%）被认为是成功的可行性终点。与非补片组相比，补片组在 6 个月时 OSS 显著改善（中位数差值 9.76（95%CI 2.25，17.29）和 SPADI：22.97（95%CI 3.02，42.92），Constant 评分无实质性差异。补片组有更高比例的参与者在 OSS（78%比 62%）和 SPADI（63%比 50%）方面改善大于 MCID。对 48 对 MRI 的分析表明，冈上肌（53%至 55%）和冈下肌（26%至 29%）的脂肪分数在 6 个月时略有增加。这些差异在按治疗组分析时相似且方向相同。两组的 Goutallier 评分保持不变或恶化一级。
本研究表明，使用不可吸收补片增强修复巨大肩袖撕裂的确定性临床试验是可行的。在这些患者中，补片有潜力在 6 个月时改善肩部症状。
ISRCTN，ISRCTN79844053，2014 年 10 月 15 日注册（回顾性注册）。
