Groot Lichelle, Gademan Maaike G J, Peter Wilfred F, van den Hout Wilbert B, Verburg Hennie, Vliet Vlieland Thea P M, Reijman Max
Department of Orthopedic Surgery, Erasmus MC, University Medical Center Rotterdam, P.O. Box 2040, 3000 CA, Rotterdam, Netherlands.
Department of Orthopedic Surgery, LUMC, Leiden University Medical Center, P.O. Box 9600, 2300 RC, Leiden, The Netherlands.
BMC Musculoskelet Disord. 2020 Aug 14;21(1):544. doi: 10.1186/s12891-020-03511-y.
Physiotherapy is a proven effective treatment strategy after total knee and hip arthroplasty (TKA/THA), however there is considerable practice variation regarding its timing, content and duration. This study aims to compare the (cost-) effectiveness of a standardized, treat-to-target postoperative physiotherapy strategy with usual postoperative care.
Using a cluster randomized study design, consecutive patients scheduled for a primary TKA/THA in 18 hospitals in the Netherlands will be assigned to the treat-to-target physio therapy strategy or usual postoperative care. With the treat-to-target strategy a standardized, individually tailored, exercise program is aimed at the attainment of specific functional milestones. Assessments are done at baseline, 6 weeks and 3, 6, 9 and 12 months follow up. The primary outcome will be the Knee injury / Hip disability and Osteoarthritis Outcome Score - Physical Function Short Form (KOOS-PS / HOOS-PS) at 3 months follow up. Secondary outcomes are the numeric rating scale for pain, the Oxford Knee and Hip Scores, performance-based test and the EuroQol 5D-5L for quality of life. Healthcare use, productivity and satisfaction with postoperative care are measured by means of questionnaires. In total, 624 patients will be needed of which 312 TKA and 312 THA patients.
The study will provide evidence concerning the (cost-) effectiveness of the treat-to-target postoperative physiotherapy treatment compared to usual postoperative care. The results of this study will address an important evidence gap and will have a significant impact in daily practice of the physio therapist.
Registered in the Dutch Trial Registry on April 15, 2018. Registration number: NTR7129 .
物理治疗是全膝关节置换术和全髋关节置换术(TKA/THA)后经证实有效的治疗策略,然而在其时机、内容和持续时间方面存在很大的实践差异。本研究旨在比较标准化的、靶向治疗的术后物理治疗策略与常规术后护理的(成本)效益。
采用整群随机研究设计,将荷兰18家医院计划接受初次TKA/THA的连续患者分配至靶向治疗物理治疗策略组或常规术后护理组。采用靶向治疗策略时,一个标准化的、个性化定制的运动计划旨在实现特定的功能里程碑。在基线、6周以及3、6、9和12个月随访时进行评估。主要结局将是3个月随访时的膝关节损伤/髋关节功能障碍和骨关节炎结局评分-身体功能简表(KOOS-PS/HOOS-PS)。次要结局包括疼痛数字评定量表、牛津膝关节和髋关节评分、基于表现的测试以及用于生活质量的欧洲五维健康量表(EuroQol 5D-5L)。通过问卷测量医疗保健使用情况、生产力和对术后护理的满意度。总共需要62位患者,其中312例TKA患者和312例THA患者。
本研究将提供证据,证明与常规术后护理相比,靶向治疗的术后物理治疗的(成本)效益。本研究结果将填补一个重要的证据空白,并将对物理治疗师的日常实践产生重大影响。
于2018年4月15日在荷兰试验注册中心注册。注册号:NTR7129 。