A Post-market Observational ORIGIN® CR Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 199
- 试验地点
- 2
- 主要终点
- Evaluate safety by the proportion of required revisions
研究概览
简要总结
The study objective is to evaluate safety and performance of the ORIGIN® CR (cruciate retaining) devices and associated instruments, more precisely to evaluate safety by the proportion of patients requiring a revision (i.e. revision rate) at 1-year post procedure and to evaluate performance by means of a Knee Society Score (KSS) Knee Score at 1 year post procedure and by means of a KSS Function Score also at 1 year post procedure.
The hypothesis raised for this study, regarding the scoring, is that patients will experience a marked improvement in the natural feel of the prosthesis during the first year after the surgery, and slightly significant improvement at the following interval of 2 years. The overall patient satisfaction is expected to be improved after 2 years follow-up with ORIGIN® CR.
详细描述
The study is a prospective, non-comparative, non-randomized, single-arm, observational, post market study in which 199 patients will be enrolled to evaluate the safety and performance of the ORIGIN® CR devices and associated instruments.
Patients will be included in the study during 18 months (inclusion window) and followed-up for 24 months.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female over 18 years of age
- •Each patient who is willing to give informed consent.
- •Clinically indicated for a total knee replacement
- •Females who are not pregnant and not planning to become pregnant ≤ 12 months. A pregnancy test should be performed for women of childbearing age
- •Geographically stable and willing to return to the implanting site for all follow-up visits at 1 year and 2 years.
排除标准
- •Acute or chronic, local or systemic infection
- •Muscular, ligamental, neurological, psychological or vascular deficits
- •Bone destruction or poor bone quality likely to affect implant stability (requiring a femoral and/or a tibial stem and/or a thick insert)
- •Any concomitant condition likely to affect implant integration or function
- •Allergy or hypersensitivity to any of the materials used
- •For devices in CoCrMo (ISO 5832/4): renal and hepatic impairment
- •Hip Knee Ankle (HKA) angle < 165° or > 195°
- •Severe collateral ligaments deficiency (requiring a more constrained prosthesis)
- •Posterior cruciate ligament deficiency
- •Major anatomical deformities
- •Severe flexion contracture or severe recurvatum
- •Revision of a partial or total knee prosthesis
- •Non-extractible material (e.g. screws, plate, intramedullary nail, osteosynthesis material...) which can create a conflict with any component of the prosthesis
- •Distal and/or posterior and/or anterior femoral bone loss which exceeds the femoral component thickness
- •Proximal tibial bone loss which exceeds the tibial component thickness (tibial tray + tibial insert)
- •Bone degradation requiring an anchoring stem for femoral component
结局指标
主要结局
Evaluate safety by the proportion of required revisions
时间窗: 1 year post-procedure
Proportion of patients requiring a revision after 1-year post-procedure. The revision rate is consistent with the state of the art - Orthopaedic Data Evaluation Panel (ODEP) benchmark system (revision rate not higher than 2.5% to 3.5% at 1 year, 4% to 6% at 5 years and 5% to 7% at 10 years).
Evaluate performance
时间窗: 1 year post-procedure
Evaluate performance by means of following questionnaires: Knee Society Score (KSS) and a Knee Society Function score, a partient-reported outcome measure. The KSS contains questions in 2 sections: knee joint (pain, range of motion, stability) and function (walking distance, ability to climb stairs). When calculating the score, deductions are taken for assistive devices and flexion contractures, misalignment, or extension lag. The maximum points which can be reached are 100 points. * Clinical status assessed by means of the KSS Knee score at 1 year post procedure * Clinical status assessed by means of the KSS Function score at 1 year post procedure
次要结局
- Evaluate safety by the proportion of required revisions(2 years post procedure)
- Performance on patient satisfaction(1- and 2-years post-procedure)
- Quality of Life post-procedure measured by the Knee Society score and Knee Society function questionnaire(1- and 2-years post-procedure)
- Quality of Life post-procedure measured by the Forgotten Joint Score questionnaire(1- and 2- years post-procedure)