To evaluate the effectiveness of using a bioinductive patch on tendon healing, functional recovery, and safety in arthroscopic rotator cuff repair. A non-concurrent controlled study with prospective enrollment of the intervention group and retrospective collection of the control group was conducted. Patients with rotator cuff injuries admitted between June 2024 and March 2025 were enrolled. The sample size was calculated using G*Power software. A total of 60 patients meeting the selection criteria were enrolled, including 30 patients in the patch group (receiving arthroscopic rotator cuff repair combined with bioinductive patch implantation) and 30 patients in the control group (receiving arthroscopic rotator cuff repair only). There was no significant difference between groups ( P>0.05) in baseline data, including age, gender, affected side, disease duration, DeOrio-Cofield classification, degree of fatty infiltration, proportion involving the subscapularis, proportion of revision surgeries, and preoperative visual analogue scale (VAS) score, Constant-Murley score, American Shoulder and Elbow Surgeons (ASES) score, and University of California, Los Angeles (UCLA) score. The following indicators were compared between groups: the tendon healing rate at 6 months postoperatively and postoperative pain VAS score, functional scores (Constant-Murley, ASES, UCLA), imaging indicators (tendon thickness, footprint coverage, effusion), and patient-reported outcomes [12-Item Short-Form Health Survey (SF-12) physical/mental component score, SF-36 overall score, simple shoulder test (SST), satisfaction]. Additionally, subgroup analyses were performed based on whether the tear involved the subscapularis preoperatively, the degree of fatty infiltration (Goutallier grades Ⅰ, Ⅱ/Ⅲ, Ⅳ), and primary/revision surgery to compare tendon healing outcomes. A multiple linear regression model was used to analyze independent influencing factors of Constant-Murley score improvement at 6 months postoperatively. Incisions in both groups healed by first intention. All patients were followed up, with follow-up time of (13.0±1.8) months in the patch group and (12.8±1.9) months in the control group, showing no significant difference ( t=0.415, P=0.680). The pain and shoulder joint function of the two groups gradually improved over time, and the corresponding scores showed significant differences between different time points ( P<0.05). The pain relief and functional recovery improvement in the patch group was better than that in the control group, and there were significant differences in all scores between groups at 1 and 6 months ( P<0.05). At 6 months postoperatively, the patch group had significantly better SF-12 physical component scores, SF-36 overall scores, and SST scores than the control group ( P<0.05), while the SF-12 mental component score and patient's satisfaction showed no significant difference between groups ( P>0.05). At 12 months postoperatively, the surgical success rate was significantly higher in the patch group than in the control group ( P<0.05). Imaging review showed no significant difference between groups in tendon healing rate, retear rate, complete footprint coverage rate, or effusion degree at 6 months postoperatively ( P>0.05), but the increase in tendon thickness was significantly greater in the patch group than in the control group ( P<0.05). Subgroup analysis showed that for revision surgery patients, there was no significant difference in retear rate based on patch use ( P>0.05); however, primary surgery patients had a significantly higher tendon healing rate with patch use ( P<0.05). For patients with Goutallier grade Ⅰ, Ⅱ fatty infiltration, patch use resulted in a significantly higher tendon healing rate ( P<0.05), while for those with grade Ⅲ, Ⅳ fatty infiltration, the difference was not significant ( P>0.05). For patients with or without involvement of the subscapularis, there was no significant difference in tendon healing rate based on patch use ( P>0.05). Multiple linear regression analysis showed that independent influencing factors of Constant-Murley score improvement at 6 months postoperatively included the use of bioinductive patch, age, and fatty infiltration degree ( P<0.05). The bioinductive patch can effectively promote joint functional recovery and structural improvement after rotator cuff repair with good safety. 评估关节镜下肩袖修复术中使用生物诱导型补片对肌腱愈合、功能恢复及安全性的影响。. 采用前瞻性收集干预组+回顾性对照的非同期对照研究,以2024年6月—2025年3月收治的肩袖损伤患者为研究对象,通过G*Power软件计算样本量,共纳入60例符合选择标准患者,分为补片组(接受关节镜下肩袖修复联合生物诱导型补片植入)和对照组(仅接受关节镜下肩袖修复)。两组患者年龄、性别、患肢侧别、病程、DeOrio-Cofield分级、脂肪浸润程度、累及肩胛下肌构成比及翻修手术构成比,以及术前疼痛视觉模拟评分(VAS)、Constant-Murley评分、美国肩肘外科协会(ASES)评分及美国加州大学洛杉矶分校(UCLA)评分等基线资料比较,差异均无统计学意义( P>0.05),具有可比性。比较两组以下指标:术后6个月肌腱愈合率,以及术后疼痛VAS评分、功能评分(Constant-Murley、ASES、UCLA)、影像学指标(肌腱厚度、足印区覆盖、积液)、患者主观评价 [简单肩关节测试(SST)、12 条目健康调查简表(SF-12)生理/心理评分、SF-36总体评分、手术满意度]。同时,两组根据术前撕裂是否累及肩胛下肌、脂肪浸润程度(Goutallier Ⅰ、Ⅱ级/Ⅲ、Ⅳ级)、首次/翻修手术进行亚组分析,比较肌腱愈合情况;采用多重线性回归模型分析术后6个月Constant-Murley评分改善独立影响因素。. 两组术后切口均Ⅰ期愈合。患者均获随访,随访时间补片组(13.0±1.8)个月,对照组(12.8±1.9)个月,差异无统计学意义( t=0.415, P=0.680)。两组患者疼痛与肩关节功能随时间延长逐渐改善,相应评分不同时间点间差异均有统计学意义( P<0.05);且补片组疼痛缓解和功能恢复改善优于对照组,术后1、6个月评分组间差异有统计学意义( P<0.05)。术后6个月补片组SF-12生理评分、SF-36总体评分、SST评分均优于对照组( P<0.05),SF-12心理评分及患者满意度组间差异无统计学意义( P>0.05)。术后12个月补片组手术成功率高于对照组,差异有统计学意义( P<0.05)。影像学复查示,术后6个月补片组肌腱愈合率及再撕裂率、足印区完全覆盖率、积液程度差异均无统计学意义( P>0.05),但补片组肌腱厚度增加值高于对照组( P<0.05)。亚组分析示,对于翻修手术患者,是否使用补片再撕裂率差异无统计学意义( P>0.05);但首次手术患者使用补片后肌腱愈合率更高( P<0.05)。脂肪浸润Goutallier Ⅰ、Ⅱ级患者使用补片后肌腱愈合率更高( P<0.05),而Ⅲ、Ⅳ级患者差异无统计学意义( P>0.05)。对于是否累及肩胛下肌患者,是否使用补片肌腱愈合率差异均无统计学意义( P>0.05)。多重线性回归分析示,术后6个月Constant-Murley评分改善的独立影响因素包括使用生物诱导型补片、年龄、脂肪浸润程度( P<0.05)。. 生物诱导型补片可有效促进肩袖修复术后关节功能恢复与结构改善且安全性好。.
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