Elbow Heterotopic Ossifications Associated With Radial Head Prosthesis: Risk and Prognostic Factors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Prevalence of EHO
研究概览
简要总结
Elbow heterotopic ossification (EHO) is described as the formation of ectopic bone in tissues not supposed to around elbow. The EHO physiopathology, yet not clarified, has been suggested to be a multifactorial process in which immune system, inflammatory response, CNS and tissue expressed proteins after severe trauma boost hyperactive metabolically bone with no periosteal layer. Consistent with that, EHO has been widely related to elbow trauma, including bone, ligament, muscle or joint; iatrogenic trauma, including epicondylectomy or elbow arthroplasty; neural injuries or burns. Clinical manifestations of EHO has been reported as limited range of motion (ROM), muscle, nerve or joint pain, stiffness and ankylosis all of them leading to upper extremity disfucntion. Prevalence of EHO can range from 3%-45% depending on degree of elbow injury. To our knowledge, prevalence of EHO among radial head fractures had not been assessed previously.
详细描述
Prevention of EHO has been proposed to be managed with a range of nonsurgical treatment options such as: radiotherapy, NSAIDS and biphosphonate. However, none of them had become clear effective above others, and only surgical excision of EHO had become a reliable option to overcome its associated limitations in elbow motion. Classic approaches suggested delayed surgery until maturity of heterotopic bone, however recent literature suggest early excisions of immature ossification to obtain favorable functional results.
Several studies have investigated risk factors of EHO regarding the high patient burden and health costs to which is associated, however, few published data exists about prevalence and risk factors of EHO after radial head arthroplasty.
Our aim is to assess the prevalence and predictor factors that can lead to EHO after radial arthroplasty in order to be able to predict and apply early preventive treatment to improve postoperative functional outcomes among patients with severe radial head fractures.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults between 18-85 years-old
- •Comminuted radial head fractures treated with radial head arthroplasty
排除标准
- •Younger than 18 years; Older than 85 years
- •History of previous elbow injuries or operations.
- •Pathologic fractures
- •Infections
结局指标
主要结局
Prevalence of EHO
时间窗: 12 months
Assess prevalence of EHO after radial head arthroplasty in anteroposterior and lateral radiographs.
Site of EHO in elbow
时间窗: 12 months
Location of EHO in elbow anteroposterior and lateral X-rays (anterior, posterior, medial, lateral).
Average size of EHO
时间窗: 12 months
Size of EHO (measure in mm) in X-rays.
Osteopenia of the capitellum
时间窗: 12 months
The radiographs of the elbow will be review for osteopenia of the capitellum, and graded as none, mild, moderate, or severe according to the system of Lamas et al. (2011).
Degenerative changes of the elbow
时间窗: 12 months
In anteroposterior and lateral X-rays. For the degree of degenerative change of the elbow, classified as Grade 0 (normal joint), Grade 1 (slight joint, space narrowing and minimum osteophyte formation), Grade 2 (moderate joint space narrowing and moderate osteophyte formation), or Grade 3 (severe degenerative changes with gross destruction of the joint) according to the system of Broberg and Morrey (1986).
次要结局
- Radial head fracture and associated elbow lesions(12 months)