Joeris Alexander, Hurtado-Chong Anahí, Hess Denise, Kalampoki Vasiliki, Blauth Michael
AO Clinical Investigation and Documentation (AOCID), AO Foundation, Dübendorf, Switzerland.
Department of Trauma Surgery, Medical University of Innsbruck, Innsbruck, Austria.
BMJ Open. 2017 Jul 12;7(7):e014795. doi: 10.1136/bmjopen-2016-014795.
Treatment of fractures in the elderly population is a clinical challenge due partly to the presence of comorbidities. In a Geriatric Fracture Centre (GFC), patients are co-managed by a geriatrician in an attempt to improve clinical outcomes and reduce morbidity and mortality. Until now the beneficial effect of orthogeriatric co-management has not been definitively proven. The primary objective of this study is to determine the effect of GFC on predefined major adverse events related to a hip fracture compared to usual care centres (UCC). The secondary objectives include assessments in quality of life, patient-reported outcomes and cost-effectiveness.
Two hundred and sixty-six elderly patients diagnosedwith hip fracture and planned to be treated with osteosynthesis or endoprosthesis in either a GFC or UCC study site will be recruited, 133 per type of centre. All procedures and management will be done according to the site's standard of care. Study-related visits will be performed at the following time points: preoperative, intraoperative, discharge from the orthopaedic/trauma department, discharge to definite residential status, 12 weeks and 12 months postsurgery. Data collected include demographics, residential status, adverse events, patient-reported outcomes, fall history, costs and resources related to treatment. The risk of major adverse events at 12 months will be calculated for each centre type; patient-reported outcomes will be analysed by mixed effects regression models to estimate differences in mean scores between baseline and follow-ups whereas cost-effectiveness will be assessed using the incremental cost-effectiveness ratio.
Ethics approval for this study was granted from the local Ethics Committees or Institutional Review Board from each of the participating sites prior to patient enrolment. The results of this study will be published in peer-reviewed journals and presented at different conferences.
ClinicalTrials.gov: NCT02297581; pre-results.
老年人群骨折的治疗是一项临床挑战，部分原因在于并存疾病的存在。在老年骨折中心（GFC），患者由老年病科医生共同管理，以期改善临床结局并降低发病率和死亡率。迄今为止，骨科与老年病科共同管理的有益效果尚未得到明确证实。本研究的主要目的是确定与常规护理中心（UCC）相比，老年骨折中心对与髋部骨折相关的预定义主要不良事件的影响。次要目的包括对生活质量、患者报告结局和成本效益的评估。
将招募266例诊断为髋部骨折且计划在老年骨折中心或常规护理中心研究地点接受骨合成或假体植入治疗的老年患者，每种中心类型各133例。所有程序和管理将根据各地点的护理标准进行。与研究相关的访视将在以下时间点进行：术前、术中、从骨科/创伤科出院时、出院至确定居住状态时、术后12周和12个月。收集的数据包括人口统计学信息、居住状态、不良事件、患者报告结局、跌倒史、与治疗相关的成本和资源。将计算每种中心类型在12个月时发生主要不良事件的风险；患者报告结局将通过混合效应回归模型进行分析，以估计基线与随访之间平均得分的差异，而成本效益将使用增量成本效益比进行评估。
在患者入组前，本研究已获得各参与地点的当地伦理委员会或机构审查委员会的伦理批准。本研究结果将发表在同行评审期刊上，并在不同会议上展示。
ClinicalTrials.gov：NCT02297581；预结果。
