A Monocentric Clinical Study Evaluating Clinical and Patient-reported Outcomes of Reverse Shoulder Arthroplasty With SMR Stemless
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Subjective Shoulder Value score
研究概览
简要总结
The objectives of this study are the assessment of the clinical, radiographical and patient-reported outcomes of SMR Stemless Reverse Shoulder Arthroplasty (LimaCorporate S.p.A.) used as standard of care over a period of at least 2 years of follow-up and the evaluation of the incidence of any complication.
详细描述
The focus of this study is the evaluation on clinical, patient-reported and radiographical outcomes of SMR Stemless Reverse Shoulder Arthroplasty. There is a retrospective and prospective study population.
The follow up time-points are (as of standard of care and not different for this study):
- Baseline
- 6 weeks postop
- 6 months postop
- 12 months postop
- 24 months postop
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
- •rotator-cuff arthropathy, osteoarthritis
- •approving written informed consent
排除标准
- •Female patients who are pregnant, nursing, or planning a pregnancy.
- •All adult patients with any of the SMR Stemless contraindication for use for the reverse configuration as reported in the current local Instruction for use.
- •not consenting in participating in this study
结局指标
主要结局
Subjective Shoulder Value score
时间窗: 5 years
Evaluation of the change of the Subjective Shoulder Value score from pre-operative to the last follow-up visit.
次要结局
- ASES Shoulder Score(5 years)
- Loosening, implant stability, radiolucent lines(1 year)
- Quick-Dash score(5 years)
- UCLA shoulder score(5 years)
- VAS pain(5 years)
研究者
Prof. Dr. med Claudio Rosso
Principal Investigator
Arthro Medics AG