Evaluation of Long-term Clinical and Radiographic Outcomes of Radio-capitellar Prostheses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Mayo elbow performance score (MEPS):
研究概览
简要总结
The aim of this study is to collect clinical and radiographic data from the case histories of patients surgically treated for radio-capitellar fracture and undergoing prosthetic replacement with a modular metal radio-capitellar prosthesis with smooth stem at the Shoulder-Elbow Department of the Rizzoli Orthopaedic Institute, in order to evaluate the clinical and radiographic results at least 10 years after surgery.
详细描述
The aim of the study is to collect clinical and radiographic data from the case history of patients (about 30 cases) surgically treated from 2003 to 2011 at the Shoulder-Elbow Department of the Rizzoli Orthopaedic Institute for radio-capitellar fracture with prosthetic replacement with a modular metal radio-capitellar prosthesis with smooth stem in order to evaluate the clinical and radiographic results at least 10 years after treatment. Patients will be contacted to perform a clinical examination and radiographic control at the Rizzoli Orthopaedic Institute.
This is an interventional study with clinical and radiographic evaluation, at FU of at least 10 years, of patients treated surgically with prosthetic replacement for radio-capitellar fracture at the Shoulder-Elbow Department of the Rizzoli Orthopaedic Institute.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years of age at the time of radial capitate implantation surgery
- •Males and Females
- •Patients surgically treated for radial capitellum fracture undergoing prosthetic replacement with smooth-stemmed modular metal radial capitellum prosthesis at the Shoulder-Elbow Department of the Rizzoli Orthopaedic Institute from 2003 to 2011.
排除标准
- •< 18 years old at the time of surgery
- •Patients treated with radial capitellum prosthesis implantation in fracture outcomes (e.g., secondary instability)
- •Patients who at the time of telephone contact have contraindications to the execution of radiographic examination
- •All available patients will be invited to perform the clinical examination and radiographic examination. If some patients are unable to undergo radiography due to possible contraindications, they will still be seen to collect the primary clinical outcome.
结局指标
主要结局
Mayo elbow performance score (MEPS):
时间窗: At least 10 years after radiocapitellar prosthesis surgical treatment
MEPS score assesses the presence of pain with a score of 0 to 45, Range of Motion with a score of 0 to 20, elbow stability with a score of 0 to 10, and the ability to perform 5 activities of daily living (combing, eating, personal hygiene, dressing, and putting on shoes) to each of which 5 points are assigned. It provides a result from 0 to 100 where results above 90 are defined as excellent, results between 75 and 89 are defined as good, between 60 and 74 are defined as sufficient and below 59 as poor.
次要结局
- Broberg - Morrey Score(At least 10 years after radiocapitellar prosthesis surgical treatment)
- Radiographic assesment (RX)(At least 10 years after radiocapitellar prosthesis surgical treatment)
- Treatment opinion post- surgery(At least 10 years after radiocapitellar prosthesis surgical treatment)
- Short Form-12 (SF-12):(At least 10 years after radiocapitellar prosthesis surgical treatment)