Hip-allograft In Proximal Humerus Fractures Versus Plate Implantation Alone: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Constant Murley Score
研究概览
简要总结
Proximal humerus fractures (PHFs) are common osteoporotic fractures in adults and the elderly, leading to significant disability and reduced quality of life. Current treatment options for displaced PHFs include locking plate fixation (LCP) and various augmentation techniques, but there is no consensus on the optimal treatment. Although, femoral allografts have shown promising results, there is a need for more definitive evidence regarding the utilization of femoral graft augmentation in addition to locking plate fixation in 3- and 4-part PHFs. This study aims to evaluate the effectiveness of using a mushroom-shaped femoral allograft combined with LCP fixation compared to LCP fixation alone. We hypothesize that femoral allograft augmentation with LCP fixation will result in better clinical and functional outcomes than LCP fixation alone at 24 months post-operative
详细描述
Rationale: Proximal humerus fractures (PHFs) are common osteoporotic fractures in adults and the elderly, leading to significant disability and reduced quality of life. Current treatment options for displaced PHFs include locking plate fixation (LCP) and various augmentation techniques, but there is no consensus on the optimal treatment. Although, femoral allografts have shown promising results, there is a need for more definitive evidence regarding the utilization of femoral graft augmentation in addition to locking plate fixation in 3- and 4-part PHFs.
This study aims to evaluate the effectiveness of using a mushroom-shaped femoral allograft combined with LCP fixation compared to LCP fixation alone. We hypothesize that femoral allograft augmentation with LCP fixation will result in better clinical and functional outcomes than LCP fixation alone at 24 months post-operative.
Objective:
Primary Objective: To compare the CMS between patients treated with LCP fixation plus femoral allograft and those treated with LCP fixation alone at 24 months. The CMS is a validated tool used for assessing overall shoulder function, incorporating bothsubjective and objective components.
Secondary Objectives: To assess differences in clinical outcomes (using Oxford Shoulder Score, Subjective Shoulder Value, Numeric Rating Scale, EQ-5DL), radiological outcomes (humeral head height, humeral neck shaft angle), and the incidence of complications at 24 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between 40 and 70 years
- •Presenting with acute (< 3 weeks) 3- or 4-part PHF (NEER classification) Be able to understand and communicate in Dutch; Patient must be competent to make decisions; Patient is willing and able to complete scheduled study procedures Provide written IC.
排除标准
- •Head-split fractures;
- •Pathological fractures due to malignancy or metastases;
- •Individuals diagnosed with dementia or residing in institutional care or other cognitive impairment;
- •Terminal illness; Patients with convulsive disorders, collagen diseases, and any other condition that might affect the mobility of the shoulder joint; Active joint or systemic infection; History of prior surgery on the same shoulder; Previous fracture in the same shoulder; Psychiatric illness that precludes informed consent.
研究组 & 干预措施
Locking plate fixation alone
Locking plate fixation alone
Intervention
Locking plate fixation with femoral allograft augmentation
干预措施: Locking plate fixation with femoral allograft augmentation (Procedure)
结局指标
主要结局
Constant Murley Score
时间窗: 24 months
Change in Constant Murley Score
次要结局
- Oxford Shoulder Score(6 weeks, 6 months, 12 months and 24 months)
- NRS(6 weeks, 6 months, 12 months and 24 months)
- EQ-5D(6 weeks, 6 months, 12 months and 24 months)
- SSV(6 weeks, 6 months, 12 months and 24 months)