Safety and Clinical Performance Assessment of Bone Cements and Cement Restrictor Used in Arthroplasty - A Post-market Clinical Follow-up
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Teknimed
- 入组人数
- 1,050
- 试验地点
- 10
- 主要终点
- Survival rate
研究概览
简要总结
A Post-Market Clinical Follow-Up (PMCF) Study to collect clinical data on safety and performance of all Teknimed Arthroplasty range of products: CEMFIX® and GENTAFIX® bone cements families and CEMSTOP® cement restrictor, and all their private labels.
Teknimed bone cements and cement restrictor are legacy products, some marketed for more than 20 years. Their performance and safety have already been demonstrated by Post-Market Surveillance and previous clinical studies. The current Post-Market Clinical Follow-Up study aims to confirm these claims by collecting data in a "real-life" setting.
The study is a retrospective and prospective global, single arm, non-controlled, multicentric, ambispective observational study. Patients will be followed as per local standard medical care of the site.
详细描述
It is admitted that:
- Joint replacement is a commonly performed major surgical procedure that has considerable success in alleviating pain and disability;
- These procedures may be done with the help of a bone cement (PMMA) to fix the prosthesis to the bone (cemented fixation);
- Most common reasons for primary joint replacement are osteoarthritis, osteonecrosis and trauma;
- Most common reasons for revision of joint replacement are dislocation, infection, fracture and prothesis loosening;
- Quality of bone cement have a large influence on long-term implant stability.
TEKNIMED has developed several bone cements and a cement restrictor currently used in arthroplasty procedures.
With the increasing use of these procedures, there is a need of real-life long-term safety and efficacy data on the bone cements.
This retro- and prospective study is performed to assess the safety and performance of TEKNIMED arthroplasty products in their current clinical use.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Be 18 years or older.
- •Be willing to sign an informed consent approved by Institutional Review Board (IRB) or European Commission (EC) (when applicable) or not oppose to the use of their clinical data in the study
- •For prospective inclusion: be considered for an arthroplasty procedure with one of the TEKNIMED orthopaedic cement and/or cement restrictor comprised in this study (primary or revision surgery).
- •For retrospective inclusion: have undergone a primary or revision arthroplasty procedure with a TEKNIMED orthopaedic cement and/or cement restrictor between the 1st January 2016 and the date of the site initiation visit (SIV).
- •Be informed of the study and not being opposed to the use of their clinical data in the study or be willing to sign an informed consent during the first follow-up visit following the site initiation (where applicable).
排除标准
- •Patient under trusteeship or guardianship,
- •Women who are pregnant
- •Patient unable to follow the protocol
- •Patient whose vital prognosis is unfavorable (according to investigator's opinion)
结局指标
主要结局
Survival rate
时间窗: 15 years (until the lifetime of the device)
Prosthesis survival defined as time from implantation to revision surgery due to a cement defect.
Superficial and/or deep postoperative infection rate.
时间窗: 15 years (until the lifetime of the device)
In the case of cements with gentamicin, superficial and/or deep postoperative infection rate.
次要结局
- Adverse events(15 years (until the lifetime of the device))
- Evaluation of function and radiological outcomes(5 years)
- Complications rate(5 years)
- Antalgic consumption(5 years)
- Pain Level(5 years)
- Patients' satisfaction(5 years)
- Restoration of function(5 years)