Tolk Jaap J, Janssen Rob P A, Haanstra Tsjitske M, Bierma-Zeinstra Sita M A, Reijman Max
Máxima Medical Center, Department of Orthopedic Surgery and Trauma, PO Box 90052, 5600 PD, Eindhoven, The Netherlands.
Department of Orthopedic Surgery, Radboud University Medical Center, PO Box 9101, 6500 HB, Nijmegen, The Netherlands.
Trials. 2018 Aug 14;19(1):437. doi: 10.1186/s13063-018-2821-2.
One out of five patients is unsatisfied to some extent after total knee arthroplasty (TKA). Unmet expectations are the main driver of post-operative dissatisfaction. Improved pre-operative education on realistic expectations for long-term outcome after TKA potentially leads to higher post-operative satisfaction. The effect of expectation modification on post-operative satisfaction in TKA patients has not yet been studied. The primary objective of the presented study is to examine whether an educational module on long-term recovery after TKA will improve patient satisfaction compared to usual pre-operative education.
The EKSPECT study is a randomized controlled trial. Patients with symptomatic and radiographic knee osteoarthritis who are indicated for a primary TKA will be randomized to the usual pre-operative education (control group) or usual education plus an additional module on realistic expectations for long-term recovery (intervention group). Patients will be naïve to study objective and difference between study groups. Outcome expectations will be measured blinded for group allocation using the HSS Knee Replacement Expectations Survey at baseline (before the intervention), pre-operatively (after the intervention) and fulfillment of expectations at 12-month follow-up. Baseline physical function, quality of life and psychological factors are measured using self-reported questionnaires. The primary outcome measure is satisfaction with treatment result at the 12-month follow-up.
The EKSPECT study should provide evidence on the effectiveness of an education module on long-term recovery after TKA to improve treatment satisfaction. If beneficial, the education module is a simple intervention with a low burden for patients, which can easily be implemented in clinical practice.
Dutch Trial Registry registration number: NTR5779 . Registered on 17 March 2016.
五分之一的患者在全膝关节置换术(TKA)后会在某种程度上感到不满意。未满足的期望是术后不满意的主要原因。改善对TKA术后长期结果的现实期望的术前教育可能会提高术后满意度。期望调整对TKA患者术后满意度的影响尚未得到研究。本研究的主要目的是检验与常规术前教育相比,关于TKA术后长期恢复的教育模块是否会提高患者满意度。
EKSPECT研究是一项随机对照试验。有症状且经影像学检查确诊为膝关节骨关节炎并计划进行初次TKA的患者将被随机分为常规术前教育组(对照组)或常规教育加关于长期恢复的现实期望的附加模块组(干预组)。患者对研究目的和研究组之间的差异不知情。将在基线(干预前)、术前(干预后)以及12个月随访时对期望实现情况进行测量,使用HSS膝关节置换期望调查问卷对组分配进行盲法测量。使用自我报告问卷测量基线身体功能、生活质量和心理因素。主要结局指标是12个月随访时对治疗结果的满意度。
EKSPECT研究应提供证据,证明关于TKA术后长期恢复的教育模块对提高治疗满意度的有效性。如果有益,该教育模块是一种简单的干预措施,对患者负担较小,可轻松在临床实践中实施。
荷兰试验注册中心注册号:NTR5779。于2016年3月17日注册。