Post Market Clinical Follow-up Study for Arthroplasty Shoulder System of FX Solutions at the Long Term Retro-Prospective, Non-Randomized, Non-Interventional Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 416
- 试验地点
- 20
- 主要终点
- Clinical outcomes
研究概览
简要总结
This study takes place in the framework of the Post-Market Clinical Follow-up of the FX Solutions Shoulder System. The goal of this PMCF study is to collect clinical data in order to confirm the safety and the performance at a long term and mainly the first two years of sales for each studied ranges.
Eligible patients who received the FX Solutions Shoulder System and are at about 7 years post-operative were contacted by the Investigator to explain the study, the retrospective collection and the prospective follow-up visit. Investigator also explain the analysis of the post-operative outcomes of the patient. During the call of the investigator, the patient was informed about the study's goal and about the data collection. The oral agreement of the patient was checked by the investigators in CRF with its signature. Then, an information form explaining the purpose of the data collection was provided to the patient by postmail.
The retrospective data were collected in a paper CRF via the medical file of patient.
Post-operative follow-up for all patients is limited to a teleconsultation intended to assess the patient's current condition and clinical outcomes.
Patient who are enrolled in the study shall be assigned a unique Subject Identification Number to de-identify their information.
详细描述
Inclusion Criteria
- Adult patient (≥ 18 years old) who received one of FX Solutions Shoulder System for indication of hemi or total shoulder replacement.
- Patient implanted between 2011 and 2015 with a minimum follow-up of 7 years
- Patient has been informed of his participation in a clinical study and did not object to data collection
- Patient insured with a social security system
Exclusion Criteria
- Patient who does not meet the inclusion criteria above
- Protected adult
- People deprived of their liberty
Study Objectives
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •First of all, in order to be eligible to the study protocol, patients should have been treated primarily with one of studied device depending on surgeons' strategies' cares.
- •In order to be eligible to participate in this study, patients must meet all of the following criteria:
- •Adult patient (≥ 18 years old) who received one of FX Solutions Shoulder System for indication of hemi or total shoulder replacement.
- •Patient implanted between 2011 and 2015 with a minimum follow-up of 7 years
- •Patient has been informed of his participation in a clinical study and did not object to data collection
- •Patient insured with a social security system
- •Exclusion criteria for subject selection.
- •Patient who does not meet the inclusion criteria above
- •Protected adult
- •People deprived of their liberty
排除标准
- 未提供
结局指标
主要结局
Clinical outcomes
时间窗: between 6 and 10 years depending on the date of implantation of the medical device in each treatment group
Functional scores measurement with Constant-Murley's Score
subjective evaluation by the patient of shoulder function
时间窗: between 6 and 10 years depending on the date of implantation of the medical device in each treatment group
Measurement with subjective shoulder value (SSV)
Articular functional measurement scores
时间窗: between 6 and 10 years depending on the date of implantation of the medical device in each treatment group
measurement with American Shoulder and Elbow Surgeons Shoulder Score (ASES)
次要结局
- Survival rate(between 6 and 10 years depending on the date of implantation of the medical device in each treatment group)
- Last information for deceased patient(between 6 and 10 years depending on the date of implantation of the medical device in each treatment group)
- Range of Motion scores(between 6 and 10 years depending on the date of implantation of the medical device in each treatment group)
- Last information for patient lost to follow-up(between 6 and 10 years depending on the date of implantation of the medical device in each treatment group)
- Rate of complication(between 6 and 10 years depending on the date of implantation of the medical device in each treatment group)
- Revision rate(between 6 and 10 years depending on the date of implantation of the medical device in each treatment group)