Post-Market Clinical Follow Up for Total Knee Arthroplasty System Madison
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- Revision rate according to Kaplan-Meier
研究概览
简要总结
MADISON Total Knee Prosthesis is intended to be used for total knee arthroplasty to reduce pain and restore joint mobility of the knee.
Clinical data for MADISON Total Knee Prosthesis available are not deemed sufficient to support performance and benefits claimed on the whole lifetime of the product.
Thus, in order to maintain compliance with the EU regulation (2017/745) related to medical devices and following ISO 14/155:2020, SERF has set up post-market clinical follow-up study (PMCF) to confirm safety and performance of Total Knee Arthroplasty system MADISON. This study is designed to cover the expected 15-years follow-up, to retrieve data according to implant feature (Posterior Stabilized or Ultra Congruent) or fixation method and to gather data related to the revision of partial knee prosthesis.
The primary objective of this study is to assess the clinical safety of MADISON total knee prostheses. The secondary objective is to evaluate the survival rates, the clinical performances and clinical benefits of MADISON total knee prosthesis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Male or female adults (≥ 18 years) covered by French social security system
- •Diagnosed with:
- •Osteoarthritis (primary and secondary),
- •Revision of a unicompartmental knee prosthesis.
- •Patient requiring a surgery and implantation of a Madison TKA (Total Knee Arthroplasty)
- •Patient physically and mentally able to comply with protocol, meet the follow-up visits as deemed by the investigator and fill in quality of life questionnaire.
- •Patient having signed a written informed consent
排除标准
- •Progressive, acute or chronic infection, local to the operative site or systemic that may affect the prosthetic joint,
- •Any loss of musculature or serious lesions of muscles, nerves and/or blood vessels deficiency, putting the affected limb at risk,
- •Lack of bone substance or inadequate bone quality on femoral or tibial surfaces, as it might compromise the stability of the prosthesis components,
- •Skeletal immaturity,
- •Pathologies that may compromise the functionality of the implant in any way (i.e. osteomyelitis, neuropathic joint),
- •Parameters incompatible with satisfactory long-term results (i.e. age, weight,
- •Neurological condition of the patient incompatible with the post-operative constraints associated with this type of intervention,
- •Known allergy to one of the implant components.
- •Severe obesity with or without comorbidities
- •Pregnant or nursing women,
- •Patients with a contraindication to radiography
- •Patients deprived of their liberty or hospitalised without their consent
- •Patients under legal protection (e.g. guardianship)
结局指标
主要结局
Revision rate according to Kaplan-Meier
时间窗: 15 years
Assess the revision rate, whatever the cause of revision, including infection at 15 years
次要结局
- Adverse events(From per operative period to 15 years)
- Survival rate according to Kaplan-Meier(From per operative period to 15 years)
- Functional improvement using 2011KSS score(From per operative period to 15 years)
- Patient's expectation / satisfaction using 2011KSS score(From per operative period to 15 years)
- Pain reduction using 2011KSS score(From per operative period to 15 years)
- Pain Evaluation using KOOS(From per operative period to 15 years)
- Functional improvement in Daily Living using KOOS(From per operative period to 15 years)
- Assessement of Knee-Related Quality of Life using KOOS(From per operative period to 15 years)
- Oblivion of prosthesis(From per operative period to 15 years)
- Mobility improvement(From per operative period to 15 years)
- Functional improvement in Sport and Recreation using KOOS(From per operative period to 15 years)
- Functional improvement Other Symptoms using KOOS(From per operative period to 15 years)