Retro-Prospective Postmarket Clinical Study For FX Shoulder Solutions Long Cemented HUMELOCK II®
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 4
研究概览
简要总结
This study takes place in the framework of the PostMarket Clinical Follow-up plan of the HUMELOCK II(r) long cemented humeral stem (shoulder prosthesis) commercialized by FX SHOULDER SOLUTIONS.
The included cases will be followed for 10 years after index surgery. Primary objective is the assessment in real life of the revision rate of the shoulder systems at long-term.
Secondary objectives are
- Revision rate at each post op visit
- Range of motion at each post op visit
- Constant Score, American Shoulder and Elbow Surgeons Shoulder Score (ASES), Pain score (VAS) at each post op visit
- Radiological assessment of implant positioning through geometrical parameters at each post op visit
- Incidence of complications at each post op visit
详细描述
Recruitment of patients can be retrospective or prospective, mainly retrospectively. Follow-up will be prospective from the date of study inception.
Recruitment will include all cases available at the selected investigation centers.
Prospective follow-up of the patients after inclusion at 6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years , 7 years and 10 years postoperatively.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Indication for hemi anatomic or total reversible shoulder replacement with Long Cemented HUMELOCK II® humeral stem for Trauma or Revision indication, according to its IFU and surgical technique.
- •Patient aged 18 years and above
- •Patient insured with a social security system
- •Has been informed and did consent to participate to the study.
排除标准
- •Neurological pathologies compromising the shoulder stability
- •Morbid obesity
- •Muscular deficiencies impairing the shoulder joint