Reverse Shoulder Arthroplasty Versus Conservative Treatment For Complex Proximal Fractures in Elderly Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 81
- 试验地点
- 2
- 主要终点
- Pain, Mobility, Strenght and Daily Life Activities. (Functional Outcome)
研究概览
简要总结
Reverse shoulder prosthesis has recently emerged as an acute treatment for complex proximal humeral fractures. Promising functional results have been reported in observational papers.
However, no clinical trials have yet been reported when comparing the conservative treatment to surgical treatment through the use of reverse shoulder arthroplasty.
详细描述
Introduction The proximal humeral fractures are frequent in the investigator's environment. Among them, about 20% are considered as complex features. Conservative treatment has traditionally offered an extensive range of results. The reverse shoulder prosthesis as a treatment for acute fractures of the proximal humeral in the elderly population has changed the therapeutic approach of this acute pathology. However, high-level evidence-based studies are still not available, when comparing the conservative treatment with the treatment with reverse shoulder prosthesis.
Objective To compare the functional results and complications of elderly patients presenting acute complex fractures of the proximal humerus through two types of treatments; conservative treatment and treatment with reverse shoulder prosthesis.
Methodology A prospective, multicentre and randomized study comparing conservative treatment with the surgical treatment at two years followup by the use of functional shoulder assessment (Constant scale), complications and re-interventions associated with each treatment. The quality of life will also be analyzed through the SF-36 health questionnaire
Expected results The null hypothesis of the work is based on the appearance of non-significant differences between the two groups of the study (conservative vs. surgical treatment), concerning functional status, complications, and re-interventions
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with mental conditions available for rehabilitation protocols
- •Patients presenting a 3 or 4 part proximal humeral fracture
排除标准
- •Extremely displaced fractures with no bony contact or less than 1 cm.
- •Cognitive impairment (Pfeiffer test >3)
- •Shoulder dislocations
- •Unable to sign informed consent or unable to respond to questionnaires
- •Trauma or previous surgery of the extremity
- •Open or pathological fracture
- •Vascular or neurological injury associated
- •Unable to collaborate with rehabilitation
- •Patients with serious comorbidities that discourage surgery
结局指标
主要结局
Pain, Mobility, Strenght and Daily Life Activities. (Functional Outcome)
时间窗: 1 year
Constant-Murley Score. The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient.The Constant-Murley score was introduced to determine the functionality after the treatment of a shoulder injury and it ranges from 0 to 100 points. The test is divided into four subscales: pain (0 to 15 points), activities of daily living (0 to 20 points), strength (0 to 25 points) and range of motion: forward elevation (0 to 10 points), external rotation (o to 10 points), abduction (0 to 10 points) and internal rotation of the shoulder (0 to 10 points). Then, those range of motion items allocate from 0 to 40 points to the global score. The higher the score, the higher the quality of the function.
次要结局
- Number of participants with treatment-related surgical reinterventions(1 year)
- Number of participants with treatment-related shoulder joint infection(1 year)
- Number of participants with treatment-related Implant dislocation(1 year)
研究者
Joan Miquel
Orthopaedic Surgeon, Principal Investigator
Consorci Sanitari de l'Anoia