Mazzocca Augustus D, Arciero Robert A, Shea Kevin P, Apostolakos John M, Solovyova Olga, Gomlinski Gregg, Wojcik Karen E, Tafuto Vincent, Stock Harlan, Cote Mark P
University of Connecticut Health Center, Farmington, Connecticut, U.S.A.
University of Connecticut Health Center, Farmington, Connecticut, U.S.A..
Arthroscopy. 2017 Jun;33(6):1138-1148. doi: 10.1016/j.arthro.2016.10.017. Epub 2017 Jan 19.
To compare the effect of early versus delayed motion protocols on quality of life, clinical outcomes, and repair integrity in patients who have undergone arthroscopic single-tendon rotator cuff repair.
This was a prospective, randomized, investigator-blinded clinical trial. Seventy-three patients from a single surgeon's practice who underwent arthroscopic repair of a single-tendon rotator cuff tear were randomized to either an early motion protocol (starting 2 to 3 days after surgery) or a delayed motion protocol (starting 28 days after surgery). The primary outcome measure was the Western Ontario Rotator Cuff index (WORC). Secondary outcome measures included clinical outcome scores, integrity of the repair on 6-month magnetic resonance imaging scans, pain scores, physical examination data, and ultrasonography. Study participants were followed up at 3, 6, and 12 weeks; 6 months; and 1 year postoperatively.
There was no statistically significant difference in WORC scores at 6 months (529 ± 472 in delayed group vs 325 ± 400 in early group, P = .08). Mixed-effects analysis indicated the early group maintained lower WORC scores throughout the postoperative period (estimated difference of 191, P = .04). The proportions of patients with tears on the 6-month postoperative magnetic resonance imaging scan were comparable (31% in delayed group vs 34% in early group, P = .78).
There was no difference between the delayed and early motion groups in WORC scores at 6 months after surgery. Early motion was associated with lower WORC scores throughout the postoperative period; however, both groups had a similar trajectory of improvement, suggesting both protocols have the same effect on patient-reported improvement. Although failure rates were similar between the groups, the sample size was not sufficient to support a statement regarding the relation between tear morphology and the rehabilitation protocol.
Level II, lesser-quality randomized controlled trial.
比较早期与延迟运动方案对接受关节镜下单肌腱肩袖修复术患者的生活质量、临床结局及修复完整性的影响。
这是一项前瞻性、随机、研究者盲法的临床试验。来自单一外科医生诊所的73例接受关节镜下单肌腱肩袖撕裂修复术的患者被随机分为早期运动方案组(术后2至3天开始)或延迟运动方案组(术后28天开始)。主要结局指标是西安大略肩袖指数(WORC)。次要结局指标包括临床结局评分、术后6个月磁共振成像扫描的修复完整性、疼痛评分、体格检查数据及超声检查。研究参与者在术后3、6和12周;6个月;以及1年进行随访。
6个月时WORC评分无统计学显著差异(延迟组为529±472,早期组为325±400,P = 0.08)。混合效应分析表明,早期组在整个术后期间WORC评分维持较低水平(估计差异为191,P = 0.04)。术后6个月磁共振成像扫描显示撕裂的患者比例相当(延迟组为31%,早期组为34%,P = 0.78)。
术后6个月时,延迟运动组和早期运动组的WORC评分无差异。早期运动与整个术后期间较低的WORC评分相关;然而,两组改善轨迹相似,表明两种方案对患者报告的改善效果相同。尽管两组失败率相似,但样本量不足以支持关于撕裂形态与康复方案之间关系的陈述。
II级,质量较低的随机对照试验。