NCT05314387

尚未招募

不适用

A Multicentre, Prospective Clinical Study Analysing Outcomes of Shoulder Arthroplasty With SMR TT Hybrid Glenoid With or Without SMR Cementless Finned Short Stem

Limacorporate S.p.a0 个研究点目标入组 100 人开始时间: 2022年4月最近更新: 2022年4月6日

适应症Shoulder Arthritis Shoulder Osteoarthritis Arthrosis Osteoarthritis Rheumatoid Arthritis Arthroplasty Avascular Necrosis Humeral Fractures Cuff Tear Arthropathy

概览

阶段: 不适用
状态: 尚未招募
发起方: Limacorporate S.p.a
入组人数: 100
主要终点: Proportion of patients reaching a clinical progression from baseline to 24-month follow-up

概览研究设计入排标准结局指标研究者记录与标识符相似试验

概览

简要总结

Post-market, prospective, non randomized, open label, multicentre, clinical study analysing outcomes of shoulder arthroplasty with SMR TT Hybrid Glenoid with or without SMR Cementless Finned Short Stem

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 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Both genders;
•Age ≥ 18 years old;
•Full skeletal maturity;
•Life expectancy over 5 years;
•Patient is requiring primary unilateral arthroplasty based on physical examination and medical history;
•Good bone quality evaluated by the Investigator and the intraoperative evaluation;
•A diagnosis in the target shoulder of one or more of the S-11 SMR TT Hybrid Glenoid and Cementless Finned Short Stem Version Sep 2021 2.0 Confidential Page11 following:
•Primary osteoarthritis;
•Secondary osteoarthritis;
•Post-traumatic arthritis;

排除标准

未提供

结局指标

主要结局

Proportion of patients reaching a clinical progression from baseline to 24-month follow-up

时间窗: 24 Months

The primary endpoint consists of the proportion of patients reaching a clinical progression from baseline to 24-month follow-up measured as: * Constant score improvement of greater than 10; * Adjusted Constant score greater than or equal to 54.

次要结局

Measure American Shoulder and Elbow Surgeons Shoulder Score (ASES)(Baseline to 24 and 60 Months)
Measure Oxford shoulder score(Baseline to 24 and 60 Months)
Measure Constant Score(Baseline to 24 and 60 Months)
Measure Simple Shoulder Test(Baseline to 24 and 60 Months)
Stability of the SMR TT hybrid glenoid component with or without SMR cementless finned short stem(Immediately postoperative to 24 Months)
System conversion rate, intended as a conversion within the SMR system from anatomic to reverse(24 Months)
Measure Patient Satisfaction(Baseline to 24 and 60 Months)
Failure rate, intended as removal of the SMR TT hybrid glenoid component(Immediately postoperative to 24 Months)
Failure rate, intended as removal of the SMR cementless finned short stem(Immediately postoperative to 24 Months)
Survival rate (Kaplan-Meier)(60 Months)
Incidence of device-related AE/SAE (ADE/SADE)(Immediately postoperative to 24 and 60 Months)

研究者

发起方

Limacorporate S.p.a

申办方类型

Industry

责任方

Sponsor

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