Post-market Observational Study of the ORIGIN® PS Modular Total Knee Prosthesis and Associated Instruments
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
- 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® PS (postero-stabilized) Modular devices and associated instruments, more precisely to evaluate safety by the proportion of patients requiring a revision (i.e. revision rate) at 2-6 months, 1y and 2y post-procedure and to evaluate performance by means of a Knee Society Score (KSS) Score at 2-6 months, 1y and 2y 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® PS Modular.
详细描述
The study is ambispective, post market, non-comparative, non-randomized, multicentric and observational in which 200 patients will be enrolled to evaluate the safety and performance of the ORIGIN® PS Modular 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
- Other
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 or female over 18 years of age.
- •Patient, or if applicable, his or her guardian or legal representative, willing to give informed consent.
- •Clinically indicated for first intention total knee replacement.
- •Geographically stable and willing to return for all follow-up visits or, at a minimum, to complete the patient self-report score.
排除标准
- •Vulnerable subject (as defined in ISO-14155)
- •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.
- •Any concomitant condition likely to affect implant integration or function,
- •Allergy or hypersensitivity to any of the materials used,
- •For devices in CoCr Mo (ISO 5832/4): renal and hepatic impairment,
- •Hip Knee Ankle (HKA) angle < 165° or > 195°,
- •Severe collateral ligament deficiency (requiring a more constrained prosthesis),
- •Major anatomical deformities,
- •Severe flexion contracture or severe recurvatum,
- •Revision of a partial or total knee prosthesis,
- •Non-extractible material (e.g., screw, 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: 2 years post-op procedure
Proportion of patients requiring a revision at each follow-up visit (surgery, 2-6 months, 1- and 2 years). 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: 2 years post-op procedure
Evaluate performance by means of a Knee Society Score (KSS) and a KSS Function score. It aims to reach a KSS Knee score of at least 85,5 / 100 points and a KSS Function score of at least 72,5 / 100 points.
次要结局
- Evaluate the success of the surgical procedure by means of a surgeon satisfaction questionnaire.(Perioperative)
- Evaluate safety by analyzing the occurencies of adverse events.(Perioperative and 2 years post-op procedure)
- Patient Quality of Life by means of the FJS score(2 years post-op procedure)