Clinical Results and RSA Migration Analysis of the GLOBAL ICON - Stemless Anatomic Shoulder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Constant-Murley Score (CMS)
研究概览
简要总结
The primary goal of the clinical trial is to determine that the GLOBAL ICON implant system from DePuy does not exhibit worse shoulder function after 2 years than the SIMPLICITY from Wright Medical. The primary endpoint is the Constant-Murley Shoulder Score (CMSS) of the implant after 2 years, the non-inferiority of which is to be demonstrated in comparison with an already established prosthetic system (SIMPLICITY, Wright Medical).
详细描述
The primary goal of the clinical trial is to determine that the GLOBAL ICON implant system from DePuy does not exhibit worse shoulder function after 2 years than the SIMPLICITY from Wright Medical. The primary endpoint is the Constant-Murley Shoulder Score (CMSS) of the implant after 2 years, the non-inferiority of which is to be demonstrated in comparison with an already established prosthetic system (SIMPLICITY, Wright Medical).
As secondary endpoints, the migration behavior of the humeral components over time will be determined by radiostereometric analysis (RSA), the further clinical-functional results and the satisfaction of the patients treated will be investigated. Clinical outcomes are measured using standardized and reproducible clinical scores (Oxford Shoulder Score -OSS and Short Form Health 36-SF-36 v1.0 ) at each time of examination.
Other endpoints include revision rate within the follow-up period, surgical time (incision to suture), and delays in surgical procedures due to instrumentation.
The times of data acquisition are the admission day before the operation to determine the preoperative status, the discharge day and the follow-up appointments after 3 months, 6 months, 12 months and 24 months to determine the postoperative status and course.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Trial participants need primary total shoulder replacement due to primary osteoarthritis or post-traumatic osteoarthritis
- •Trial participants are willing to take part in the clinical trial and intend to be available for the planned follow-up examinations.
- •Male, female and various subjects with age on the day of surgery from 18 to 80 years inclusive.
- •Subjects agree not to participate in any other clinical trial for at least 2 years (+ 3 weeks) using the index procedure. This includes clinical trials of medication, invasive procedures and medical devices. Questionnaire-based studies or other studies that are non-invasive and do not involve drug use are allowed.
- •Exclusion of intraoperative circumstances that require the implantation of a prosthesis type other than that provided for in the clinical trial (depending on the surgeon).
排除标准
- •Previous operation on the rotator cuff of the affected shoulder
- •Dysfunctional rotator cuff
- •Infection of the affected shoulder joint or systemic infection
- •Pregnant or breastfeeding women and those who are planning to become pregnant for up to 2 years (+3 weeks) using the index procedure
研究组 & 干预措施
Shoulder prosthesis system GLOBAL ICON from DePuy
The GLOBAL ICON stemless is a shaftless shoulder prosthesis system for anatomical reconstruction of the shoulder joint in cases of total or hemiarthroplasty in the shoulder. The base plate consists of titanium coated with hydroxyapatite, the head of cobalt-chrome.
干预措施: Total joint arthroplasty of the glenohumeral joint (Device)
SIMPLICITY shoulder prosthesis system from Wright Medical
The SIMPLICITY is a shaftless shoulder prosthesis system for anatomical reconstruction of the shoulder joint in cases of total or hemiarthroplasty in the shoulder. The base plate consists of titanium coated with hydroxyapatite, the head of cobalt-chrome.
干预措施: Total joint arthroplasty of the glenohumeral joint (Device)
结局指标
主要结局
Constant-Murley Score (CMS)
时间窗: 24 months postoperative
The CMS covers different aspects of shoulder pathology: pain, activities of daily living, range of motion and strength. The possible maximum total score is 100 points (best function). Pain and activities of daily living are answered by the patient; range of motion and strength are answered by the orthopaedic surgeon.
次要结局
- Oxford Shoulder Score (OSS)(24 months postoperative)
- Short Form Health 36 (SF-36)(24 months postoperative)