Background:Whether the use of PRP as an adjuvant of rotator cuff repairs leads to improved tendon healing and better functional outcomes remains unclear in clinical evidence.Purpose:The main purpose of this study was to assess whether the use of leukocyte-poor platelet-rich plasma (LP-PRP) as an adjuvant to arthroscopic rotator cuff repair (ARCR) decreases the rate of retears compared with a control group. The secondary objective was to analyze whether LP-PRP improves patient-reported outcomes.Study Design:Randomized controlled trial; Level of evidence, 1.Methods:This was a double-blind randomized controlled trial at a single center. A consecutive series of 96 patients with rotator cuff tears <3 cm were enrolled and randomly allocated to the control group (double-row suture-bridge ARCR alone [n = 48]) and the PRP group (double-row suture-bridge repair, followed by 1 LP-PRP injection during surgery [n = 48]). The visual analog scale (VAS) for pain, the American Shoulder and Elbow Surgeons (ASES) score, the Single Assessment Numeric Evaluation (SANE), and the Pittsburgh Sleep Quality Index (PSQI) were administered preoperatively and at 6- and 12-month follow-up. Magnetic resonance imaging (MRI) was performed to evaluate tendon integrity at 6-month follow-up. Both patients and assessors were blinded to the intervention received during surgery.Results:The mean patient age was 56.1 ± 2.98 years. Of the 96 patients, 90 had MRI performed at 6 months after surgery (94% radiological follow-up). The retear rate in the PRP group was 15.2% (7/46 [95% CI, 6%-28%]), which was lower than that in the control group of 34.1% (15/44 [95% CI, 20%-49%]) ( P = .037). Therefore, the risk ratio of ruptures in patients exposed to LP-PRP was 0.44 (95% CI, 0.2-0.9; P = .037). Overall, the ASES, VAS, SANE, and PSQI scores showed a statistical improvement after surgery ( P < .001). There were no significant differences in functional scores between the groups. Most of the patients exceeded the minimal clinically important difference for the ASES, SANE, and VAS without significant differences between the groups.Conclusion:In patients with rotator cuff tears <3 cm undergoing double-row suture-bridge repair, a 5-mL dose of LP-PRP injected at the tendon-bone interface significantly reduced the retear rate. However, the use of LP-PRP in terms of postoperative pain and patient-reported outcomes failed to show clinically meaningful effects.Registration:NCT04703998 (ClinicalTrials.gov identifier).

中文翻译：

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缺乏白细胞的富含血小板的血浆作为关节镜肩袖修复的辅助剂可降低撕裂率，但不会改善功能结果：双盲随机对照试验

背景：临床证据中使用 PRP 作为肩袖修复的辅助剂是否会改善肌腱愈合和更好的功能结果仍不清楚。目的：本研究的主要目的是评估使用缺乏白细胞的富含血小板的药物是否可以改善肌腱愈合并改善功能结果。与对照组相比，血浆（LP-PRP）作为关节镜肩袖修复术（ARCR）的辅助剂可降低再撕裂率。次要目标是分析 LP-PRP 是否可以改善患者报告的结果。研究设计：随机对照试验；证据水平，1.方法：这是一项单中心双盲随机对照试验。连续纳入 96 名肩袖撕裂 <3 cm 的患者，并随机分配到对照组（仅双排缝合桥 ARCR [n = 48]）和 PRP 组（双排缝合桥修复，随后在手术期间注射 1 次 LP-PRP [n = 48]）。术前以及 6 个月和 12 个月时进行疼痛视觉模拟量表 (VAS)、美国肩肘外科医生 (ASES) 评分、单一评估数字评估 (SANE) 和匹兹堡睡眠质量指数 (PSQI)跟进。在 6 个月的随访中进行磁共振成像 (MRI) 来评估肌腱的完整性。患者和评估人员均对手术期间接受的干预不知情。结果：患者平均年龄为 56.1 ± 2.98 岁。在 96 名患者中，90 名患者在术后 6 个月进行了 MRI 检查（94% 进行了放射学随访）。 PRP组的再延迟率为15.2%（7/46 [95% CI, 6%-28%]），低于对照组的34.1%（15/44 [95% CI, 20%]） -49%]）（P = .037）。因此，暴露于 LP-PRP 的患者破裂的风险比为 0.44（95% CI，0.2-0.9；P = .037）。总体而言，术后 ASES、VAS、SANE 和 PSQI 评分显示出统计性改善 ( P < .001)。各组之间的功能评分没有显着差异。大多数患者超过了 ASES、SANE 和 VAS 的最小临床重要差异，但组间无显着差异。结论：在接受双排缝线桥修复的肩袖撕裂 <3 cm 的患者中，5 mL 剂量在肌腱-骨界面注射 LP-PRP 显着降低了延迟率。然而，LP-PRP 在术后疼痛和患者报告结果方面的使用未能显示出具有临床意义的效果。注册：NCT04703998（ClinicalTrials.gov 标识符）。