Tornier Perform® Humeral System - Fracture Study
概览
- 阶段
- 不适用
- 干预措施
- Tornier Perform® Humeral System - Fracture
- 疾病 / 适应症
- Traumatic Arthropathy of Shoulder
- 发起方
- Stryker Trauma and Extremities
- 入组人数
- 118
- 试验地点
- 9
- 主要终点
- ASES Score = American Shoulder and Elbow Surgeons Score
- 状态
- 进行中（未招募）
- 最后更新
- 17天前
概览
简要总结
This study is an international, single arm, multicenter, prospective follow-up, non-significant risk, Post-Market Clinical Follow-up (PMCF), which is designed to collect safety and performance data on commercially available Perform® Fracture.
Data collected from this study will be used for purposes, including but not limited to, PMS, peer-reviewed publications, education materials, future regulatory submissions, and/or product development.
详细描述
This is an International, single arm, multicenter, prospective follow-up, non-significant risk, Post-Market Clinical Follow-up (PMCF) study. Data will be collected for the commercially available Perform® Fracture shoulder system in both the anatomic and reversed configurations. The primary endpoint of this study is to demonstrate decreased pain and improved subjects' shoulder functionality of daily living by achieving a mean of American Shoulder and Elbow Surgeons (ASES) shoulder score higher than 62 points, at 2-year follow-up post-operatively, regardless of configuration (anatomic or reverse). Retrospective inclusions are allowed: preoperative, intra operative, and 6 months data can be collected retrospectively up to 12 months after the surgery date. Secondary outcome measures include patient reported outcome measures (PROMs) and standard radiographic findings, including, but not limited to: bone erosion, device migration/subsidence, component breakage, radiolucency, and ossification. Safety and performance data will be collected at surgery, immediate post-op, and up to 10 years post-operation. Patient Reported Outcome Measures (PROMs), device revision and Adverse Events (AEs) will be assessed annually throughout the study. Range of Motion (ROM), strength and radiographic imaging assessments of the study shoulder will also be performed for in-person milestones visits at 6 months (radiographic imaging assessments), 1-, 2-, 5- and 10-year, post-operatively.
研究者
入排标准
入选标准
- •18 years or older at the time of the informed consent or the non-opposition (when applicable)
- •Informed and willing to sign an informed consent form (ICF) approved by IRB or EC (when applicable)
- •Willing and able to comply with the requirements of the study protocol
- •Considered a candidate for shoulder arthroplasty with the device for shoulder joint disabled by:
- •Traumatic or pathologic conditions of the shoulder resulting in fracture of the glenohumeral joint, including humeral head fracture and displaced 3-or 4-part proximal humeral fractures
- •Fracture sequelae
- •Revisions where adequate fixation can be achieved, and adequate bone stock remains after final reconstruction
- •Proximal humerus bone defect (reverse configuration)
排除标准
- •Not able to comply with the study procedures based on the judgment of the assessor (e.g., cannot comprehend study questions, inability to keep scheduled assessment times)
- •Patient belongs to a vulnerable group of subjects, including minor subjects, those unable to decide for themselves to participate or needing a LAR, or others who could be subject to coercion (subjects who may not be acting on their own initiative) (referred as "vulnerable subject" in the section 3.44 of the ISO 14155:2011 norm)
- •Any absolute contraindications as mentioned in the device Instruction For Use (available on ifu.stryker.com)
研究组 & 干预措施
Tornier Perform® Humeral System - Fracture
Commercially available convertible humeral system for anatomic and reverse shoulder arthroplasty.
干预措施: Tornier Perform® Humeral System - Fracture
结局指标
主要结局
ASES Score = American Shoulder and Elbow Surgeons Score
时间窗: 24 Month
11 items with total score reported out of 100 measuring pain and activity of patient's evaluated shoulder where lower scores indicate more pain and less function
次要结局
- EQ-5D-5L(24 Month)
- Tuberosity healing(12 Month)
- Radiographic Findings(24 Month)
- Constant Score(24 Month)
- Patient Satisfaction(24 Month)
- SANE(24 Month)