Ascension® Humeral Resurfacing Arthroplasty HRA Follow-Up Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- American Shoulder and Elbow Surgeons (ASES) Score
研究概览
简要总结
This is a prospective study on the Ascension HRA device to collect data to assess the safety and effectiveness of the HRA.
详细描述
This study protocol will provide guidance to investigators wanting to perform a non-randomized, consecutive enrollment, 10-year follow-up study of patients who are treated with the Ascension® HRA. Its purpose is to measure and document the outcomes associated with implanting the Ascension HRA prosthesis. Patients will be periodically assessed to collect data related to safety and effectiveness endpoints at the following intervals: preoperative, surgery/immediate post-op, 3 months, 6 months, 1 year, 2 year, 5 year, and 10 years.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any patient who is to be treated with the Ascension HRA is eligible for inclusion in this study. Therefore, Principal Investigators should attempt to recruit all patients at the study site who are treated with the Ascension HRA
- •The following patient will be included in the study - Patient who:
- •Is treated with the Ascension HRA
- •Is disabled by either non-inflammatory or inflammatory arthritis (i.e. rheumatoid arthritis, osteoarthritis and avascular necrosis
- •Has mild or moderate humeral head deformity and /or limited motion
- •Has post-traumatic arthritis
- •Has an intact or reparable rotator cuff
- •Has the means and ability to return for all required study visits
- •Is willing to participate in the study
- •Has signed an Informed Consent Form
- •Is at least 18 years of age and skeletally mature at the time of surgery
- •Is less than 75 years of age at the time of surgery
排除标准
- •Infection, sepsis, and osteomyelitis
- •Osteoporosis
- •Metabolic disorders which may impair bone formation
- •Osteomalacia
- •Rapid joint destruction, marked bone loss or bone resorption apparent on X-ray
- •Revision procedures where other devices or treatments have failed
- •Refuses to be in the study; or does not have the means and ability to return for all required study visits
- •Currently participating in another clinical study
结局指标
主要结局
American Shoulder and Elbow Surgeons (ASES) Score
时间窗: 2 years
The American Shoulder and Elbow Score is a functional outcome tool that has been validated for various shoulder conditions
次要结局
- Visual Analog Scale for pain(2 years)
- X-rays(2 years)
- Adverse events(Surgery; 3 month, 6 month, 1 year and 2 years post-op)
- Range of Motion(2 years)