未经批准:尽管关节镜肩袖修复术取得了最新进展,撕毁率仍然很高。必须寻求优化治愈率的新方法。骨通道可以通过吸引自体间充质干细胞产生更快,更有力的愈合反应,细胞因子,和生长因子到修复部位。
UNASSIGNED:与没有辅助通道的关节镜肩袖修复相比,带骨通道的关节镜肩袖修复将导致更高的治愈率。
未经批准:随机对照试验;证据水平,1.
UNASSIGNED:我们的主要目标是比较接受关节镜肩袖修复的患者对退行性撕裂的治愈率,有和没有骨头沟渠。次要目标包括比较西安大略肩袖指数(WORC)得分,美国肩肘外科医师(ASES)评分,恒定的分数,恒定强度子评分,组间疼痛评分的视觉模拟评分(VAS)。在3个地点招募接受关节镜肩袖修复的患者,并随机接受骨通道增强或标准修复。术后24个月通过超声确定愈合。WORC,ASES,在基线和术后3,6,12和24个月时,比较两组之间的Constant评分.
UNASSIGNED:在2013年至2018年期间,共招募了168名患者。意向治疗分析显示,术后24个月,两种干预措施之间的治愈率无统计学差异。两组在术前到WORC的所有时间点均有统计学意义的改善,ASES得分,恒定分数或恒定强度子分数,和疼痛的VAS(P<0.0001)。WORC中的骨通道和对照组之间没有观察到差异,ASES,常数,和任何时间点的VAS疼痛评分。
UNASSIGNED:该试验未证明术后24个月肩袖修补术中骨通畅优于标准肩袖修补术。愈合率,患者报告功能,两组间的生活质量结局相似.
UNASSIGNED:NCT01877772(ClinicalTrials.gov标识符)。
Despite recent advances in arthroscopic rotator cuff repair, the retear rate remains high. New methods to optimize healing rates must be sought. Bone channeling may create a quicker and more vigorous healing response by attracting autologous mesenchymal stem cells, cytokines, and growth factors to the repair site.
Arthroscopic rotator cuff repair with bone channeling would result in a higher healing rate compared with arthroscopic rotator cuff repair without adjuvant channeling.
Randomized controlled trial; Level of evidence, 1.
Our primary objective was to compare healing rates in patients undergoing arthroscopic rotator cuff repair for degenerative tears, with and without bone channeling. Secondary objectives included comparisons of the Western Ontario Rotator Cuff Index (WORC) score, American Shoulder and Elbow Surgeons (ASES) score, Constant score, Constant strength subscore, and visual analog scale (VAS) for pain score between groups. Patients undergoing arthroscopic rotator cuff repair were recruited at 3 sites and were randomized to receive either bone channeling augmentation or standard repair. Healing was determined via ultrasound at 24 months postoperatively. WORC, ASES, and Constant scores were compared between groups at baseline and at 3, 6, 12, and 24 months postoperatively.
A total of 168 patients were enrolled between 2013 and 2018. Intention-to-treat analysis revealed no statistical differences in healing rates between the 2 interventions at 24 months postoperatively. Statistically significant improvements occurred in both groups from preoperatively to all time points for the WORC, the ASES score, the Constant score or Constant strength subscore, and the VAS for pain (P < .0001). No differences were observed between the bone channeling and control groups in WORC, ASES, Constant, and VAS pain scores at any time point.
This trial did not demonstrate the superiority of intraoperative bone channeling in rotator cuff repair over standard rotator cuff repair at 24 months postoperatively. Healing rates, patient-reported function, and quality-of-life outcomes were similar between groups.
NCT01877772 (ClinicalTrials.gov identifier).