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:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- Proportion of patients reaching a clinical progression from baseline to 24-month follow-up
研究概览
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;
- •Rheumatoid arthritis;
- •Avascular necrosis
- •acute fractures of the humeral head that cannot be treated with other fracture fixation methods;
- •cuff tear arthropathy (only in combination with CTA Heads);
- •Glenoid arthrosis without excessive glenoid bone loss: A1, A2 and B1 according to Walch classification.
- •Exclusion Criteria (Key):
- •Patient requiring revision shoulder arthroplasty;
- •Osteoporosis with a history of non-traumatic fractures;
- •Steroid injections within the previous 3 months;
- •Contralateral shoulder replacement within the previous 3 months;
- •Significant proven or suspicious infection of the target shoulder or any serious infectious disease before the study according to the Investigator;
- •Significant neurological or musculoskeletal disorders that may compromise functional recovery;
- •Not recovered axillary nerve palsy;
- •Non functioning deltoid muscle;
- •Known or suspicious hypersensitivity to the metal or other components and materials of the implant;
- •Participation in any experimental drug/device study within the 6 months prior to the preoperative visit;
- •Women of childbearing potential who are pregnant, nursing, or planning to become pregnant.
- •These are key eligibility criteria, other eligibility criteria apply.
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)
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