Biomet Humeral Stem Data Collection
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- The outcome will be measured using the data collection sheets collected at each follow-up visit.
研究概览
简要总结
The purpose of this prospective clinical data collection is to document the performance and clinical outcomes of Biomet Humeral Stems.
详细描述
The purpose of this prospective clinical data collection is to document the performance and clinical outcomes of Biomet Humeral Stems.
All stems on which data will be collected are legally marketed and none of the devices are investigational or experimental. This data collection effort will document the clinical outcomes of the humeral stems. The data gathered will be collated and used to provide feedback to designing engineers, support marketing efforts, and answer potential questions from reimbursement agencies.
Inclusion/Exclusion criteria are within the indications and contraindications stated in the labeling, cleared by the FDA, for the device. Surgical techniques and patient care are to be standard for the surgeon participating in the protocol. There will be no experimental or investigational surgical techniques used. The devices and products are to be used in accordance with their instructions for use and/or approved labeling.
The outcomes and data collected include:
UCLA End-Result Score Radiographic Evaluation
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 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
- •Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- •Rheumatoid Arthritis
- •Correction of functional deformity
- •Patient selection factors to be considered:
- •Need to obtain pain relief and improve function
- •Ability and willingness of the patient to follow instructions, including control of weight and activity levels
- •A good nutritional state of the patient
- •The patient must have reached full skeletal maturity
排除标准
- •Patients who have infection, sepsis, and osteomyelitis
- •Patients who are uncooperative or have neurologic disorders who is capable or unwilling to follow directions
- •Patients who have osteoporosis
- •Patients who have metabolic disorders which may impair bone function
- •Patients with osteomalacia
- •Patients with distant foci of infections which may spread to the implant site
- •Patients with rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram
- •Patients who are pregnant
- •Patients who are under 18 years of age
结局指标
主要结局
The outcome will be measured using the data collection sheets collected at each follow-up visit.
时间窗: 5 year
次要结局
未报告次要终点