Clinical effectiveness and cost-effectiveness of open and arthroscopic rotator cuff repair [the UK Rotator Cuff Surgery (UKUFF) randomised trial]
Clinical effectiveness and cost-effectiveness of open and arthroscopic rotator cuff repair [the UK Rotator Cuff Surgery (UKUFF) randomised trial]
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DOI：
10.3310/hta19800
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发表时间：
2015-10-01
影响因子：
3.6
通讯作者：
Ramsay, Craig R.
中科院分区：
文献类型：
--
作者：
Carr, Andrew J.;Cooper, Cushla D.;Ramsay, Craig R.
背景资料：存在不确定性的最佳管理患者退行性撕裂的肩袖。目的：评估的临床效果和成本效益的关节镜下和开放式肩袖修复术的患者年龄>= 50岁的退行性肩袖肌腱tears.Design：两个平行组随机对照试验。设置：19个教学和地区综合医院在英国。参会人员：年龄≥ 50岁的退行性肩袖肌腱撕裂患者（n = 273）干预措施：关节镜手术和开放性肩袖修复，外科医生使用他们常用和首选的关节镜或开放性修复方法。术后2周和8周通过电话问卷进行随访，随机分组后8个月、12个月和24个月通过邮寄问卷进行随访。主要结局指标：24个月时的牛津肩关节评分（OSS）是主要结局指标。术后12个月对肩关节进行磁共振成像评估，以评估修复的完整性。平均OSS从基线时的26.3 [标准差（SD）8.2]改善至41.7关节镜手术从基线时的25.0（SD 8.0）增加到24个月时的41.5（SD 7.9），开放手术从基线时的25.0（SD 8.0）增加到24个月时的41.5（SD 7.9）。当显示干预措施的效应量时，负号表示开放程序更受欢迎。对于意向治疗分析，两组之间无统计学差异，24个月时OSS评分的差异为-0.76 [95%置信区间（CI）-2.75至1.22; p = 0.452]，CI排除了OSS中3分的预定临床重要差异。当按照方案比较各组时，也没有统计学差异（OSS评分差异-0.46，95% CI -5.30至4.39; p = 0.854）。调查问卷的回答率> 86%。在8个月时，77%的参与者报告肩部问题好多了或稍微好了一些，在24个月时，这一比例增加到85%。关节镜组和开放性修复组之间的任何组件资源使用类别的平均成本以及24个月的总随访成本均无显著差异。根据意向治疗分析，关节镜手术2年的总治疗费用为2567磅（SD 176）磅，开放手术为2699磅（SD 149）磅。对于符合方案分析，关节镜组和开放修复组之间的初始手术相关总成本存在显著差异，关节镜修复的成本高出371磅（95% CI 135磅至607磅）。关节镜修复组24个月时累积的总质量调整生命年平均为1.34（SD 0.05），开放修复组为1.35（SD 0.05），无显著差异0.01（95% CI -0.11至0.10）。随机化组之间的再撕裂率无显著差异（关节镜手术组和开放手术组分别为46.4%和38.6%）。无法修复撕裂的参与者的OSS最低，再次撕裂的参与者的OSS略高，修复愈合的参与者的OSS改善最多。这些结果是相同的分析时，每protocol.Conclusion：在年龄> 50岁的退行性肩袖撕裂的患者中，在2年的主要结局（OSS）和所有其他预先指定的次要结局方面，开放修复和关节镜修复的临床有效性或成本效益没有差异。未来的工作应该探索新的方法，以改善肌腱愈合，并减少本试验中观察到的高再撕裂率。
Background: Uncertainty exists regarding the best management of patients with degenerative tears of the rotator cuff.Objective: To evaluate the clinical effectiveness and cost-effectiveness of arthroscopic and open rotator cuff repair in patients aged >= 50 years with degenerative rotator cuff tendon tears.Design: Two parallel-group randomised controlled trial.Setting: Nineteen teaching and district general hospitals in the UK. Participants: Patients (n = 273) aged >= 50 years with degenerative rotator cuff tendon tears.Interventions: Arthroscopic surgery and open rotator cuff repair, with surgeons using their usual and preferred method of arthroscopic or open repair. Follow-up was by telephone questionnaire at 2 and 8 weeks after surgery and by postal questionnaire at 8, 12 and 24 months after randomisation.Main outcome measures: The Oxford Shoulder Score (OSS) at 24 months was the primary outcome measure. Magnetic resonance imaging evaluation of the shoulder was made at 12 months after surgery to assess the integrity of the repair.Results: The mean OSS improved from 26.3 [standard deviation (SD) 8.2] at baseline to 41.7 (SD 7.9) at 24 months for arthroscopic surgery and from 25.0 (SD 8.0) at baseline to 41.5 (SD 7.9) at 24 months for open surgery. When effect sizes are shown for the intervention, a negative sign indicates that an open procedure is favoured. For the intention-to-treat analysis, there was no statistical difference between the groups, the difference in OSS score at 24 months was -0.76 [95% confidence interval (CI) -2.75 to 1.22; p = 0.452] and the CI excluded the predetermined clinically important difference in the OSS of 3 points. There was also no statistical difference when the groups were compared per protocol (difference in OSS score -0.46, 95% CI -5.30 to 4.39; p = 0.854). The questionnaire response rate was > 86%. At 8 months, 77% of participants reported that shoulder problems were much or slightly better, and at 24 months this increased to 85%. There were no significant differences in mean cost between the arthroscopic group and the open repair group for any of the component resource-use categories, nor for the total follow-up costs at 24 months. The overall treatment cost at 2 years was 2567 pound (SD 176) pound for arthroscopic surgery and 2699 pound (SD 149) pound for open surgery, according to intention-to-treat analysis. For the per-protocol analysis there was a significant difference in total initial procedure-related costs between the arthroscopic group and the open repair group, with arthroscopic repair being more costly by 371 pound (95% CI 135 pound to 607) pound. Total quality-adjusted life-years accrued at 24 months averaged 1.34 (SD 0.05) in the arthroscopic repair group and 1.35 (SD 0.05) in the open repair group, a non-significant difference of 0.01 (95% CI -0.11 to 0.10). The rate of re-tear was not significantly different across the randomised groups (46.4% and 38.6% for arthroscopic and open surgery, respectively). The participants with tears that were impossible to repair had the lowest OSSs, the participants with re-tears had slightly higher OSSs and the participants with healed repairs had the most improved OSSs. These findings were the same when analysed per protocol.Conclusion: In patients aged > 50 years with a degenerative rotator cuff tear there is no difference in clinical effectiveness or cost-effectiveness between open repair and arthroscopic repair at 2 years for the primary outcome (OSS) and all other prespecified secondary outcomes. Future work should explore new methods to improve tendon healing and reduce the high rate of re-tears observed in this trial.