Vadher Karan, Knight Ruth, Barker Karen L, Dutton Susan J
Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, OX3 7LD, UK.
National Institute for Health Research Biomedical Research Unit, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, OX3 7LD, UK.
Trials. 2018 Nov 19;19(1):638. doi: 10.1186/s13063-018-3031-7.
About 15% of patients fail to achieve a satisfactory clinical outcome following knee replacement, which may indicate the existing model of rehabilitation after surgery is possibly not the most efficacious. The COmmunity-based Rehabilitation after Knee Arthroplasty (CORKA) trial evaluates the effects of a new multi-component community-based rehabilitation programme following knee replacement compared with usual care.
METHODS/DESIGN: The CORKA trial is a multi-centre, single-blind, two-arm randomised controlled trial. The primary outcome is the Late Life Function and Disability Instrument (LLFDI) overall function score measured at 12 months post-randomisation which will be analysed using a linear mixed effects model. Secondary outcomes are measured at 6 and 12 months post-randomisation and include the LLFDI frequency and limitation total dimension scores, the Oxford Knee Score, the Knee injury and Osteoarthritis Outcome Score quality of life subscale, the Physical Activity Scale for the Elderly, the EuroQol EQ-5D-5L, and several measurements of physical function. Full details of the planned analysis approaches for the primary and secondary outcomes are described here, as are the descriptive statistics which will be reported. This is an update to the CORKA protocol which has already been published in this journal.
This paper provides details of the planned statistical analyses for this trial and will reduce the risks of outcome reporting bias and data-driven results.
ISRCTN registry, 13517704 . Registered on 12 February 2015.
FUNDING/SPONSOR: The trial is funded by the National Institute for Health Research Health Technology Assessment programme under its commissioned research programme (HTA 12/196/08). The trial sponsor is the University of Oxford.
约15%的患者在膝关节置换术后未获得满意的临床结果，这可能表明现有的术后康复模式可能并非最有效。膝关节置换术后基于社区的康复（CORKA）试验评估了一种新的多成分社区康复计划与常规护理相比在膝关节置换术后的效果。
方法/设计：CORKA试验是一项多中心、单盲、双臂随机对照试验。主要结局是随机分组后12个月测量的晚年功能与残疾量表（LLFDI）总体功能评分，将使用线性混合效应模型进行分析。次要结局在随机分组后6个月和12个月测量，包括LLFDI频率和限制总分维度评分、牛津膝关节评分、膝关节损伤与骨关节炎结局评分生活质量子量表、老年人身体活动量表、欧洲五维度健康量表EQ-5D-5L以及多项身体功能测量。这里描述了主要和次要结局的计划分析方法的详细信息，以及将报告的描述性统计数据。这是已在本杂志发表的CORKA方案的更新。
本文提供了该试验计划统计分析的详细信息，将降低结局报告偏倚和数据驱动结果的风险。
国际标准随机对照试验编号注册库，13517704。于2015年2月12日注册。
资助/主办方：该试验由英国国家卫生研究院卫生技术评估计划在其委托研究计划（HTA 12/196/08）下资助。试验主办方是牛津大学。
