Retro-Prospective Postmarket Clinical Study For FX Shoulder Solutions Long Cemented HUMELOCK II®
2026年6月17日 更新者：FX Solutions
This study takes place in the framework of the PostMarket Clinical Follow-up plan of the HUMELOCK II(r) long cemented humeral stem (shoulder prosthesis) commercialized by FX SHOULDER SOLUTIONS.
The included cases will be followed for 10 years after index surgery. Primary objective is the assessment in real life of the revision rate of the shoulder systems at long-term.
Secondary objectives are
- Revision rate at each post op visit
- Range of motion at each post op visit
- Constant Score, American Shoulder and Elbow Surgeons Shoulder Score (ASES), Pain score (VAS) at each post op visit
- Radiological assessment of implant positioning through geometrical parameters at each post op visit
- Incidence of complications at each post op visit
研究概览
详细说明
Recruitment of patients can be retrospective or prospective, mainly retrospectively. Follow-up will be prospective from the date of study inception.
Recruitment will include all cases available at the selected investigation centers.
Prospective follow-up of the patients after inclusion at 6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years , 7 years and 10 years postoperatively.
研究类型
观察性的
注册 (估计的)
40
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Kathy TRIER, PhD
- 电话号码：800-280-0775
- 邮箱：ktrier@fxshouldersolutions.com
研究联系人备份
- 姓名：Gabriel GUEUGNON
- 电话号码：+33 6 09 25 38 08
学习地点
-
-
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Angers、法国、49933
- CHU d' Angers
-
接触：
- Romain LANCIGU, MD
- 电话号码：+33 6 07 02 11 34
- 邮箱：romain.lancigu@gmail.com
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Caen、法国、14000
- Hôpital privé Saint-Martin
-
接触：
- Franck DORDAIN, MD
- 电话号码：+33 2 31 06 02 56
- 邮箱：fdordain@gmail.com
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Paris、法国、75009
- Clinique Drouot Laffitte
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接触：
- Jules DERANLOT, MD
- 电话号码：+33 6 63 55 83 40
- 邮箱：dr.deranlot@gmail.com
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Saint-Priest-en-Jarez、法国、42277
- Hôpital Nord
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接触：
- Giorgio GRESTA, MD
- 电话号码：+33 6 82 79 82 89
- 邮箱：gresta@netcourrier.com
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
取样方法
非概率样本
研究人群
Study population is issued from investigators' patient population.
描述
Inclusion Criteria:
- Indication for hemi anatomic or total reversible shoulder replacement with Long Cemented HUMELOCK II® humeral stem for Trauma or Revision indication, according to its IFU and surgical technique.
- Patient aged 18 years and above
- Patient insured with a social security system
- Has been informed and did consent to participate to the study.
Exclusion Criteria:
- Neurological pathologies compromising the shoulder stability
- Morbid obesity
- Muscular deficiencies impairing the shoulder joint
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Group 1: Long Cemented HUMELOCK II® Hemi Anatomic Shoulder System for Trauma Indications
Subjects treated with cemented long HUMELOCK II® Hemi Anatomic Shoulder System for traumatic indications
|
Hemi anatomical (HSA) or reversed (RSA) shoulder arthroplasties.
|
|
Group 2: Long Cemented HUMELOCK II® Hemi Anatomic Shoulder System for Revision Indications
Subjects treated with cemented long HUMELOCK II® Hemi Anatomic Shoulder System for revision indications
|
Hemi anatomical (HSA) or reversed (RSA) shoulder arthroplasties.
|
|
Group 3: Long Cemented HUMELOCK II® Reversible Total Shoulder System for Trauma Indications
Subjects treated with cemented long HUMELOCK II® Reversible Shoulder System for traumatic indications
|
Hemi anatomical (HSA) or reversed (RSA) shoulder arthroplasties.
|
|
Group 4: Long Cemented HUMELOCK II® Reversible Total Shoulder System for Revision Indications
Subjects treated with cemented long HUMELOCK II® Reversible Shoulder System for revision indications
|
Hemi anatomical (HSA) or reversed (RSA) shoulder arthroplasties.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Revision rate (KM) at 10 years postoperative
大体时间：at the end of the postoperative follow-up period of 10 years
|
Survival rate (%) at 10 years calculated by means of Kaplan-Meier method
|
at the end of the postoperative follow-up period of 10 years
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Range of Motions at each postoperative visit
大体时间：At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)
|
At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)
|
|
|
Radiological assessment of implant positioning at each postoperative visit
大体时间：At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)
|
At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)
|
|
|
Incidence of complications at each postoperative visit
大体时间：At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)
|
At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)
|
|
|
Revision rate (KM) at each postoperative visit
大体时间：At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years)
|
Survival rate (%) at each postoperative visit calculated by means of Kaplan-Meier method
|
At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years)
|
|
Constant-Murley score at each postopererative visit
大体时间：At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)
|
The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters.
These parameters define the level of pain and the ability to carry out the normal daily activities of the patient.
The higher the score, the higher the quality of the function and the lower the pain is.
|
At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)
|
|
ASES score at each postoperative visit
大体时间：At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)
|
ASES (American Shoulder and Elbow Surgeons) score ranges from 0 to 100, with 0 the lowest level of function and 100 the highest level of function.
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At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)
|
|
VAS pain at each postoperative visit
大体时间：At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)
|
The Visual Analogue Scale (VAS) measures pain intensity.
The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').
|
At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年7月1日
初级完成 (估计的)
2036年12月31日
研究完成 (估计的)
2037年6月1日
研究注册日期
首次提交
2026年6月17日
首先提交符合 QC 标准的
2026年6月17日
首次发布 (实际的)
2026年6月23日
研究记录更新
最后更新发布 (实际的)
2026年6月23日
上次提交的符合 QC 标准的更新
2026年6月17日
最后验证
2026年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.