Ascension® Humeral Resurfacing Arthroplasty 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
- 2
- 主要终点
- American Shoulder and Elbow Surgeon Score
研究概览
简要总结
It is 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.
详细描述
At each assessment interval, information on complications and adverse events will be collected. In addition, shoulder joint range of motion will be collected, and implants will be evaluated radiographically to determine joint position and assess implant with regards to radiolucencies, subsidence and subluxation (migration). Patient satisfaction with regard to the effect of the implant on shoulder function, joint pain, and overall satisfaction will be assessed using a visual analog scale (VAS). Furthermore, if there are any implant revisions during the 10-year follow-up for any of the patients enrolled in the study, the implant and/or surrounding tissue will be harvested if possible and submitted for histopathological examination.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •The following patients will be excluded from the study - Patients who:
- •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 Surgeon Score
时间窗: Outcome data will be evaluated at 2 years
The ASES score will be evaluated at 2 years and compared to baseline.
次要结局
- AP and axillary radiographs(2 years)
- Range of Motion(2 years)
- VAS scale for pain(2 years)
- Adverse events(2 years and during entire trial)