NCT02525783已完成不适用
Aequalis Pyrocarbon Humeral Head IDE Study
Stryker Trauma and Extremities2 个研究点 分布在 1 个国家目标入组 157 人开始时间: 2015年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 157
- 试验地点
- 2
- 主要终点
- Rate of Patient Success at 24 Months.
研究概览
简要总结
The purpose of this study is to demonstrate safety and effectiveness of the Aequalis Pyrocarbon Humeral Head in hemiarthroplasty at 24 months.
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult subject 22 years or older.
- •Scapula and proximal humerus must have reached skeletal maturity.
- •Clinical indication for hemiarthroplasty due to primary diagnosis of arthritis or avascular necrosis. Primary arthritis for this study includes osteoarthritis with pain and/or post-traumatic arthritis.
- •Willing and able to comply with the protocol.
- •Willing and able to sign the informed consent formed (or the Legally Authorized Representative will sign for the subject).
排除标准
- •Active local or systemic infection, sepsis, or osteomyelitis.
- •In the opinion of the clinician, there is insufficient bone stock to support implants in the humeral metaphysis or poor bone quality.
- •In the opinion of the clinician, there is insufficient bone stock or excessive deformation of the native glenoid to allow normal functioning of the glenohumeral joint.
- •In the clinician's opinion, the subject is unwilling or unable to be compliant with the recommendations of the healthcare professional.
- •Metabolism disorders that could compromise bone formation, or Osteomalacia.
- •Infection at or near the implant site, distant foci of infections that could spread to the site of the implant, or systemic infection.
- •Rapid destruction of the joint, marked bone loss, or bone resorption apparent on X-ray.
- •Known allergy or suspected allergy to implant materials.
- •Female subjects who are pregnant or planning to become pregnant within the study period.
- •Medical conditions or balance impairments that could lead to falls. Prior arthroplasty or prior failed rotator cuff repair on the affected shoulder; (successful rotator cuff surgery may be included).
- •A rotator cuff that is not intact and cannot be reconstructed. Subjects with a massive rotator cuff tear (>5cm) will be excluded.
- •Nonfunctional deltoid muscle.
- •Neuromuscular compromise condition of the shoulder (e.g., neuropathic joints or brachial plexus injury with a flail shoulder joint).
- •Known active metastatic or neoplastic diseases, Paget's disease, or Charcot's disease.
- •Currently, within the last 6 months, or planning to be on chemotherapy or radiation.
- •Known alcohol or drug abuse as defined by DSM-
- •Taking greater than 5mg/day corticosteroids (e.g. prednisone) excluding inhalers, within 3 months prior to surgery.
- •Currently enrolled in any clinical research study that might interfere with the current study endpoints.
- •Known history of renal or hepatic disease/insufficiency.
- •Anatomy cannot be replicated using current available system sizes.
结局指标
主要结局
Rate of Patient Success at 24 Months.
时间窗: 24 Months
A subject is a success at 24 months if: * Their change in Constant score is greater than or equal to 17 and * They did not have revision surgery; and * There is no radiographic evidence of system disassembly or fracture, and * They did not have a system-related serious adverse event.
次要结局
- Constant Score(24 Months)
- Revision Rate(24 Months)
- EQ-5D Index(24 Months)
- Range of Motion (ROM)(24 Months)
- Level of Satisfaction With the Shoulder(24 Months)
- Strength(24 Months)
- X-Ray Data(24 Months)
- American Shoulder and Elbow Surgeons (ASES) Score(24 Months)
- Single Assessment Numeric Evaluation (SANE)(24 Months)
- Pain Measured by a VIsual Analog Scale (VAS)(24 Months)
- Number of Participants With Device-related Serious Adverse Events(24 Months)
研究者
研究点 (2)
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