背景:建议手术修复用于治疗高级部分和全层肩袖撕裂,尽管有证据表明手术治疗不一定优于非手术治疗。这项研究的目的是比较经皮矫形生物学治疗与家庭运动疗法治疗冈上泪液的方法。
方法:在本随机对照研究中,交叉设计,冈上肌腱撕裂的参与者接受了“BMC治疗”,由自体骨髓浓缩物(BMC)和血小板产品的组合组成,或接受了家庭锻炼治疗计划。三个月后,随机接受运动疗法的患者如果对肩关节进展不满意,可以交叉接受BMC治疗.患者报告的数字疼痛量表(NPS)结果,手臂的残疾,肩膀,手,(DASH),在1、3、6、12和24个月时收集改良的单一评估数字评估(SANE)。使用Snyder分类系统评估治疗前和治疗后的MRI。
结果:51例患者被纳入并随机分为BMC治疗组(n=34)或运动治疗组(n=17)。中位数ΔDASH的显着改善更大,ΔNPS,与运动疗法组相比,BMC治疗组报告的SANE评分(分别为-11.7vs-3.8,P=0.01;-2.0vs0.5,P=0.004;50.0vs0.0,P<0.001)。患者报告的结果在研究的两年随访期间继续进展,没有发生严重不良事件。在治疗前和治疗后都有MRI的患者中,大多数(73%)显示BMC治疗后愈合的证据.
结论:患者报告的功能变化明显更大,疼痛,与运动疗法相比,BMC治疗后的整体改善高度部分和全厚度冈上泪液。
背景:此协议已在www上注册。
结果:gov(NCT01788683;11/02/2013)。
BACKGROUND: Surgical repair is recommended for the treatment of high-grade partial and full thickness rotator cuff tears, although evidence shows surgery is not necessarily superior to non-surgical therapy. The purpose of this
study was to compare percutaneous orthobiologic treatment to a home exercise therapy program for supraspinatus tears.
METHODS: In this randomized-controlled, crossover design, participants with a torn supraspinatus tendon received either \'BMC treatment\', consisting of a combination of autologous bone marrow concentrate (BMC) and platelet products, or underwent a home exercise therapy program. After three months, patients randomized to exercise therapy could crossover to receive BMC treatment if not satisfied with shoulder progression. Patient-reported outcomes of Numeric Pain Scale (NPS), Disabilities of the Arm, Shoulder, and Hand, (DASH), and a modified Single Assessment Numeric Evaluation (SANE) were collected at 1, 3, 6, 12, and 24 months. Pre- and post-treatment MRI were assessed using the Snyder Classification system.
RESULTS: Fifty-one patients were enrolled and randomized to the BMC treatment group (n = 34) or the exercise therapy group (n = 17). Significantly greater improvement in median ΔDASH, ΔNPS, and SANE scores were reported by the BMC treatment group compared to the exercise therapy group (-11.7 vs -3.8, P = 0.01; -2.0 vs 0.5, P = 0.004; and 50.0 vs 0.0, P < 0.001; respectively) after three months. Patient-reported outcomes continued to progress through the
study\'s two-year follow-up period without a serious adverse event. Of patients with both pre- and post-treatment MRIs, a majority (73%) showed evidence of healing post-BMC treatment.
CONCLUSIONS: Patients reported significantly greater changes in function, pain, and overall improvement following BMC treatment compared to exercise therapy for high grade partial and full thickness supraspinatus tears.
BACKGROUND: This protocol was registered with www.
RESULTS: gov (NCT01788683; 11/02/2013).