Tian Jiaxin, Ding Fengxing, Wang Zhe, Muting Niu, Liu Chen, Ye Zipeng, Chen Huiang, Wu Caizhi, Yi Shaowei, Fan Yubo, Zhao Jinzhong, Cao Shiyi, Ma Bin
School of Biological Science and Medical Engineering, Beihang University, Beijing, China.
Evidence-Based Medicine Center, School of Basic Medical Sciences, Lanzhou University, Lanzhou, China.
Orthop Surg. 2025 Sep;17(9):2541-2557. doi: 10.1111/os.70141. Epub 2025 Aug 8.
Rotator cuff injuries are a leading cause of shoulder dysfunction, where bio-inductive collagen implants have demonstrated promising results in promoting tendon regeneration and reducing retear rates. However, existing evidence lacks consistent evaluation across varying follow-up durations, while the specific factors influencing their safety and effectiveness remain undetermined. This study aims to evaluate the quality of evidence regarding the safety, efficacy, and impact factors of applying the resorbable bio-inductive collagen implant clinically to repair rotator cuff injuries.
The study protocol was registered on PROSPERO (CRD42022367522). A systematic literature search of PubMed, Web of Science, Embase, and Cochrane Library (from inception to October 2024) for clinical studies on bio-inductive collagen implants for rotator cuff repair. Two investigators independently screened studies, extracted data, and assessed quality (using RoB1 for RCTs, NOS for cohort studies and JBI critical appraisal tools for case series). Primary outcomes included postoperative tendon thickness, shoulder function scores (ASES/Constant), and re-tear rates. Data were analyzed using random/fixed-effects models to calculate mean differences (MDs) with 95% CIs, with subgroup analyses for tear type, patient age, and postoperative mobilization time. Statistical analyses were performed using Stata 17.0.
Seventeen studies were included. The meta-analysis results showed that postoperative tendon thickness of the patients increased statistically compared with the baseline, at 3 months (MD = 2.22; 95% CI: 1.61, 2.83; p < 0.001), 6 months (MD = 2.30; 95% CI: 1.44, 3.16; p < 0.001), 12 months (MD = 2.15; 95% CI: 1.58, 2.72; p < 0.001), and 24 months (MD = 1.05; 95% CI: 0.02, 2.08; p = 0.045). Postoperative shoulder joint function improved significantly. The ASES score and Constant score of the patients were significantly higher than the baseline at 6 months (ASES: MD = 35.90; 95% CI: 32.97, 38.83; p < 0.001), 12 months (ASES: MD = 40.83; 95% CI: 37.56, 44.10; p < 0.001; Constant: MD = 28.59; 95% CI: 21.44, 35.74; p < 0.001), and 24 months (ASES: MD = 39.80; 95% CI: 31.32, 48.27; p < 0.001; Constant: MD = 32.84; 95% CI: 28.72, 36.97; p < 0.001).
The bio-inductive collagen implant is effective and safe for healing rotator cuff injuries. Patient age may be an important moderator affecting its efficacy. The impact of tear size and postoperative activities on efficacy needs to be further explored through in-depth clinical studies.
肩袖损伤是肩部功能障碍的主要原因，生物诱导性胶原蛋白植入物在促进肌腱再生和降低再撕裂率方面已显示出有前景的结果。然而，现有证据在不同随访期缺乏一致的评估，同时影响其安全性和有效性的具体因素仍未确定。本研究旨在评估关于临床应用可吸收生物诱导性胶原蛋白植入物修复肩袖损伤的安全性、有效性及影响因素的证据质量。
该研究方案已在PROSPERO（CRD42022367522）上注册。对PubMed、Web of Science、Embase和Cochrane图书馆（从创刊至2024年10月）进行系统文献检索，以查找关于生物诱导性胶原蛋白植入物用于肩袖修复的临床研究。两名研究者独立筛选研究、提取数据并评估质量（随机对照试验使用RoB1，队列研究使用NOS，病例系列使用JBI批判性评价工具）。主要结局包括术后肌腱厚度、肩部功能评分（ASES/Constant）和再撕裂率。使用随机/固定效应模型分析数据以计算95%置信区间的平均差异（MDs），并对撕裂类型、患者年龄和术后活动时间进行亚组分析。使用Stata 17.0进行统计分析。
纳入17项研究。荟萃分析结果显示，与基线相比，患者术后肌腱厚度在3个月（MD = 2.22；95% CI：1.61，2.83；p < 0.001）、6个月（MD = 2.30；95% CI：1.44，3.16；p < 0.001）、12个月（MD = 2.15；95% CI：1.58，2.72；p < 0.001）和24个月（MD = 1.05；95% CI：0.02，2.08；p = 0.045）时均有统计学意义的增加。术后肩关节功能显著改善。患者的ASES评分和Constant评分在6个月（ASES：MD = 35.90；95% CI：32.97，38.83；p < 0.001）、12个月（ASES：MD = 40.83；95% CI：37.56，44.10；p < 0.001；Constant：MD = 28.59；95% CI：21.44，35.74；p < 0.001）和24个月（ASES：MD = 39.80；95% CI：31.32，48.27；p < 0.001；Constant：MD = 32.84；95% CI：28.72，36.97；p < 0.001）时均显著高于基线。
生物诱导性胶原蛋白植入物修复肩袖损伤有效且安全。患者年龄可能是影响其疗效的重要调节因素。撕裂大小和术后活动对疗效的影响需要通过深入的临床研究进一步探索。
