NCT00737087终止不适用
A Multi-centred, Non-comparative, Non-randomised, Open, Post Marketing Investigation to Look at the Long-term Clinical Efficacy of the Delta Xtend Reverse Total Shoulder Used in the Treatment of Shoulders With Rotator Cuff Deficiencies.
DePuy International5 个研究点 分布在 3 个国家目标入组 144 人开始时间: 2007年11月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 144
- 试验地点
- 5
- 主要终点
- Postoperative functionality through a difference in Constant Score post-treatment, as compared with pre-treatment results.
研究概览
简要总结
This post-marketing study is designed to collect data relating to the use of the Delta Xtend™ Total Shoulder Replacement System in shoulder with rotator cuff deficiencies. This allows for continued monitoring of the performance and safety of the prosthesis in a broader range of clinical situations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects, aged less than 85 years inclusive.
- •Subjects who have cuff tear arthropathy, osteoarthritis with cuff deficiency, rheumatoid arthritis, post traumatic injury, or a need for revision surgery of a failed anatomic prosthesis in the left or right shoulder, which requires (total) shoulder arthroplasty.
- •Subjects with radiographic evidence of sufficient bone stock to seat and support the Delta XtendÔ Reverse Total Shoulder System.
- •Subjects who in the opinion of the Clinical Investigator are considered suitable for treatment with the Delta Xtend Reverse Total Shoulder System.
- •Patients with a life expectancy of greater than 12 months.
- •Subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.
- •Subjects who, in the opinion of the Clinical Investigator, are able to understand this clinical investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.
排除标准
- •Male and female subjects aged 86 years or older.
- •Subjects with complete deltoid muscle palsy in the target joint as determined by clinical evaluation.
- •Subjects with active local or systemic infection or with a history of general or local infections in the target joint over the past 12 months.
- •Subjects with severe deformities, or tumours, that would impair fixation or proper positioning of the implant.
- •Subjects with no significant muscle, nerve or vascular disease.
- •Subjects with a pathology that, in the opinion of the Clinical Investigator, will adversely affect healing.
- •Known allergic reactions to implant materials (e.g. bone cement, metal, polyethylene) implant corrosion or implant wear debris.
- •Subjects with a known history of poor compliance to medical treatment.
- •Subjects who, in the opinion of the Clinical Investigator, have an existing condition that would compromise their participation and follow-up in this clinical investigation.
- •Women who are pregnant.
- •Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
- •Subjects who have participated in a clinical investigation with an investigational product in the last month.
- •Subjects who are currently involved in any injury litigation claims.
研究组 & 干预措施
Delta Xtend Reverse Total Shoulder
Other
Orthopaedic implant for total shoulder replacement
干预措施: Delta Xtend Reverse Total Shoulder (Device)
结局指标
主要结局
Postoperative functionality through a difference in Constant Score post-treatment, as compared with pre-treatment results.
时间窗: 2 years
次要结局
- Postoperative functionality at 12weeks, 1, 2, 5 and 10 years through a difference in the Constant score, ASES score, U-Penn score and EQ-5D as compared with pre-treatment scores.(12weeks, 1, 2, 5 and 10 years)
- Determine implant survivorship and surgical revision information at 1, 2, 5 and 10 years via Kaplan-Meier survival analysis.(1, 2, 5 and 10 years)
研究者
研究点 (5)
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