Musculoskeletal Research Unit, Bristol Medical School, Bristol, UK.
Musculoskeletal Research Unit, Bristol Medical School, Bristol, UK
BMJ Open. 2021 Jan 6;11(1):e040205. doi: 10.1136/bmjopen-2020-040205.
Knee replacements are highly successful for many people, but if a knee replacement fails, revision surgery is generally required. Surgeons and patients may choose from a range of implant components and combinations that make up knee replacement constructs, all with potential implications for how long a knee replacement will last. To inform surgeon and patient decisions, a comprehensive synthesis of data from randomised controlled trials is needed to evaluate the effects of different knee replacement implants on overall construct survival. Due to limited follow-up in trials, joint registry analyses are also needed to assess the long-term survival of constructs. Finally, economic modelling can identify cost-effective knee replacement constructs for different patient groups.
In this protocol, we describe systematic reviews and network meta-analyses to synthesise evidence on the effectiveness of knee replacement constructs used in total and unicompartmental knee replacement and analyses of two national joint registries to assess long-term outcomes. Knee replacement constructs are defined by bearing materials and mobility, constraint, fixation and patella resurfacing. For men and women in different age groups, we will compare the lifetime cost-effectiveness of knee replacement constructs.
Systematic reviews are secondary analyses of published data with no ethical approval required. We will design a common joint registry analysis plan and provide registry representatives with information for submission to research or ethics committees. The project has been assessed by the National Health Service (NHS) REC committee and does not require ethical review.Study findings will be disseminated to clinicians, researchers and administrators through open access articles, presentations and websites. Specific UK-based groups will be informed of results including National Institute for Health Research and National Institute for Health and Care Excellence, as well as international orthopaedic associations and charities. Effective dissemination to patients will be guided by our patient-public involvement group and include written lay summaries and infographics.
CRD42019134059 and CRD42019138015.
膝关节置换术在许多人身上都取得了非常成功的效果，但如果膝关节置换术失败，通常需要进行翻修手术。外科医生和患者可以从一系列构成膝关节置换的植入物组件和组合中进行选择，所有这些都可能对膝关节置换的使用寿命产生影响。为了为外科医生和患者的决策提供信息，需要对随机对照试验的数据进行全面综合，以评估不同膝关节置换植入物对整体构建体存活率的影响。由于试验随访时间有限，还需要关节登记分析来评估构建体的长期存活率。最后，经济建模可以为不同患者群体确定具有成本效益的膝关节置换构建体。
在本方案中，我们描述了系统评价和网络荟萃分析，以综合有关全膝关节置换和单髁膝关节置换中使用的膝关节置换构建体的有效性证据，并对两个国家关节登记处进行分析，以评估长期结果。膝关节置换构建体由承载体材料和活动度、约束、固定和髌骨表面置换定义。对于不同年龄组的男性和女性，我们将比较膝关节置换构建体的终生成本效益。
系统评价是对已发表数据的二次分析，不需要伦理批准。我们将设计一个共同的关节登记分析计划，并为登记处代表提供提交给研究或伦理委员会的信息。该项目已由英国国民保健服务（NHS）REC 委员会评估，不需要伦理审查。研究结果将通过开放获取文章、演讲和网站向临床医生、研究人员和管理人员传播。特定的英国组织将被告知包括国家卫生研究所和国家卫生与保健卓越研究所、国际矫形协会和慈善机构在内的结果。我们的患者公众参与小组将指导向患者进行有效的传播，包括书面的通俗摘要和信息图表。
CRD42019134059 和 CRD42019138015。
