Department of Medicine, Division of Preventive and Behavioral Medicine, University of Massachusetts Medical School, 55 Lake Avenue North, Worcester, MA 01655, USA.
BMC Musculoskelet Disord. 2011 Oct 7;12:226. doi: 10.1186/1471-2474-12-226.
Total knee replacement (TKR) is a common and effective surgical procedure to relieve advanced knee arthritis that persists despite comprehensive medical treatment. Although TKR has excellent technical outcomes, significant variation in patient-reported functional improvement post-TKR exists. Evidence suggests that consistent post-TKR exercise and physical activity is associated with functional gain, and that this relationship is influenced by emotional health. The increasing use of TKR in the aging US population makes it critical to find strategies that maximize functional outcomes.
METHODS/DESIGN: This randomized clinical trial (RCT) will test the efficacy of a theory-based telephone-delivered Patient Self-Management Support intervention that seeks to enhance adherence to independent exercise and activity among post- TKR patients. The intervention consists of 12 sessions, which begin prior to surgery and continue for approximately 9 weeks post-TKR. The intervention condition will be compared to a usual care control condition using a randomized design and a probabilistic sample of men and women. Assessments are conducted at baseline, eight weeks, and six- and twelve- months. The project is being conducted at a large healthcare system in Massachusetts. The study was designed to provide greater than 80% power for detecting a difference of 4 points in physical function (SF36/Physical Component Score) between conditions (standard deviation of 10) at six months with secondary outcomes collected at one year, assuming a loss to follow up rate of no more than 15%.
As TKR use expands, it is important to develop methods to identify patients at risk for sub-optimal functional outcome and to effectively intervene with the goal of optimizing functional outcomes. If shown efficacious, this peri-TKR intervention has the potential to change the paradigm for successful post-TKR care. We hypothesize that Patient Self-Management Support to enhance adherence to independent activity and exercise will enhance uniform, optimal improvement in post-TKR function and patient autonomy, the ultimate goals of TKR.
全膝关节置换术（TKR）是一种常见且有效的手术方法，可缓解尽管进行了全面的医学治疗但仍持续存在的晚期膝关节关节炎。尽管 TKR 具有出色的技术效果，但 TKR 后患者报告的功能改善存在显著差异。有证据表明，TKR 后持续进行锻炼和身体活动与功能改善有关，而这种关系受情绪健康的影响。TKR 在不断老龄化的美国人群中的应用日益广泛，因此找到最大限度提高功能效果的策略至关重要。
方法/设计：这项随机临床试验（RCT）将测试基于理论的电话提供的患者自我管理支持干预措施的疗效，该干预措施旨在提高 TKR 后患者对独立锻炼和活动的依从性。该干预措施包括 12 个疗程，从手术前开始，持续约 9 周。干预组将与常规护理对照组进行比较，采用随机设计和概率抽样的男性和女性。评估在基线、八周、六和十二个月进行。该项目在马萨诸塞州的一家大型医疗保健系统中进行。该研究旨在为 6 个月时条件之间（标准差为 10）在物理功能（SF36/物理成分评分）方面的差异 4 分提供超过 80%的功效，假设随访丢失率不超过 15%，次要结果在一年时收集。
随着 TKR 的应用不断扩大，开发方法来识别功能结果不理想的风险患者并进行有效的干预以优化功能结果非常重要。如果证明有效，这种 TKR 围手术期干预措施有可能改变 TKR 后成功护理的模式。我们假设，增强对独立活动和锻炼的依从性的患者自我管理支持将增强 TKR 后功能和患者自主性的一致、最佳改善，这是 TKR 的最终目标。
