NCT01390038已完成3 期
Simpliciti IDE Trial
Stryker Trauma and Extremities28 个研究点 分布在 1 个国家目标入组 157 人开始时间: 2011年7月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 157
- 试验地点
- 28
- 主要终点
- Device Success Rate
研究概览
简要总结
The purpose of this study is to demonstrate safety and efficacy of the Simpliciti Shoulder System in total shoulder arthroplasty.
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult subject 22 years or older
- •Clinical indication for total shoulder replacement due to primary diagnosis of arthritis. Primary arthritis for this study includes osteoarthritis, and/or traumatic arthritis.
- •Scapula and proximal humerus must have reached skeletal maturity
- •Subject with a Constant Score ≥ 20
- •Willing and able to comply with the protocol
- •Willing and able to sign the informed consent (or the Legally Authorized Representative will sign for the subject)
排除标准
- •Lack of sufficient sound bone to seat and support the implant such as:
- •Rapid joint destruction, marked bone loss or bone resorption;
- •Destruction of the proximal humerus that precludes rigid fixation of the humeral component; and
- •Osteomalacia
- •Metal allergies or sensitivity, including a known allergic reaction to implant metals (e.g., nickel) or polyethylene
- •Infection at or near the site of implantation, including:
- •Glenohumeral joint infection
- •Osteomyelitis
- •Distant or systemic infection
- •Medical conditions or balance impairments that could lead to falls
- •Prior open shoulder surgery on the shoulder to be treated in the study including failed rotator cuff surgery, but excluding successful shoulder arthroscopy
- •Any full thickness rotator cuff tear at the time of surgery or a nonfunctional rotator cuff
- •Excessive glenoid bone loss defined by preoperative computed tomography (CT) scans of the shoulder which show insufficient glenoid bone, or insufficient bone identified at the time of surgery
- •Metabolic disorders which may impair bone function
- •Nonfunctional deltoid muscle
- •Neuromuscular compromise condition of the shoulder (e.g., neuropathic joints or brachioplexus injury with a flail shoulder joint)
- •Known active metastatic or neoplastic diseases, Paget's disease or Charcot's disease
- •Currently, or within the last 6 months, or planning to be on chemotherapy or radiation
- •Currently taking > 5mg/day corticosteroids (e.g. prednisone) excluding inhalers, within 3 months prior to surgery
- •Female subjects who are pregnant or planning to become pregnant within the study period
- •In the surgeon's opinion, the subject is unable to understand the study or be compliant with the follow up or have a history of non-compliance with medical advice
- •History of any cognitive or mental health status that would interfere with study participation
- •Alcohol or drug abuse
- •Engages in manual labor or sports activities that could affect shoulder outcome
- •Currently enrolled in any clinical research study that might interfere with the current study endpoints
结局指标
主要结局
Device Success Rate
时间窗: 24 months
A subject is a Patient Success at 24-months if: 1. There is NO continuous radiolucent line around the prosthesis; and 2. The adjusted Constant Score is \> 85 (successful outcome); and 3. They did not have revision surgery; and 4. They did not have a system-related serious adverse event.
次要结局
- Quality of Life(24 months)
- Range of Motion(24 months)
- Strength(24 months)
- Pain: Visual Analog Scale(24 Months)
- Device Parameters(24 months)
- American Shoulder and Elbow Surgeon Score(24 Months)
研究者
研究点 (28)
Loading locations...
相似试验
已完成
不适用
Comprehensive Shoulder System Nano IDEJoint DiseaseNCT01936259Zimmer Biomet258
已完成
不适用
Sidus Stem-Free Shoulder IDE StudyPosttraumatic ArthrosisRheumatoid ArthritisOsteoarthritisNCT01878253Zimmer Biomet95
招募中
不适用
Mirror Medacta Shoulder System Pivotal TrialArthritis ShoulderPost-traumatic Arthrosis of Other Joints, Upper ArmNCT05062252Medacta International SA100
已完成
不适用
Sidus(TM) Post Market Clinical Follow-up (PMCF) StudyNon-inflammatory Degenerative Joint Disease (NIDJD)Inflammatory Joint Disease (IJD)Rheumatoid ArthritisOsteoarthritisAvascular NecrosisNCT01700543Zimmer Biomet152
已完成
不适用
Novel Shoulder Rehabilitation Program (SPARS-REHAB)Rotator Cuff PathologyNCT05139173Sunnybrook Health Sciences Centre25