Clinical Evaluation of Vanguard Deep Dish Rotating Platform Knee - Cementless Fixation With Finned Stem
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 113
- 试验地点
- 2
- 主要终点
- Performance
研究概览
简要总结
This is a single cohort, prospective study of performance and safety of the Vanguard Deep Dish Rotating Platform (DD RP) cementless fixation with the goal to acquire clinical outcomes data and evaluate the performance of the device in an Austrian patient population
详细描述
This is a single cohort, prospective study of performance and safety of the Vanguard Deep Dish Rotating Platform (DD RP) - cementless fixation with finned stem. The performance will be assessed by Oxford Knee Score, and evaluation of aseptic loosening after 2 years follow up. Patient benefit will be evaluated by means of Knee injury and Osteoarthritis Outcome Score (KOOS) and EQ-5D patient questionnaire. The target enrollment is 113 patients in 1 clinical site in Linz, Austria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients scheduled to undergo primary total knee replacement:
- •with painful and disabled knee joint resulting from any of the following diagnoses:
- •Osteoarthritis,
- •Traumatic arthritis,
- •Rheumatoid arthritis with one or more compartments involved.
- •Correction of varus, valgus, or posttraumatic deformity.
- •Correction or revision of unsuccessful osteotomy or arthrodesis.
- •Need to obtain pain relief and improve function.
- •Ability and willingness to follow instructions, including control of weight and activity level, and to return for follow-up evaluations.
- •A good nutritional state of the patient.
- •Full skeletal maturity of the patient, patients who are at least 18 years of age.
- •Patients of either sex.
- •Consent form read, understood, and signed by patient.
排除标准
- •Absolute contraindications include the following diagnoses:
- •Infection
- •Osteomyelitis
- •Previous partial or total prosthetic knee replacement on the operative side
- •Skeletal immaturity of the patient
- •Patients who are less than 18 years of age
- •Relative contraindications include:
- •uncooperative patient or patient with neurologic disorders who are incapable of following directions,
- •osteoporosis,
- •metabolic disorders which may impair bone formation,
- •osteomalacia,
- •distant foci of infections which may spread to the implant site,
- •rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram,
- •vascular insufficiency, muscular atrophy, neuromuscular disease,
- •incomplete or deficient soft tissue surrounding the knee
结局指标
主要结局
Performance
时间窗: 2 years
The performance will be assessed by evaluation of the rate of aseptic loosening of femoral or tibial components within 2 years follow up.
次要结局
- Patient benefits(10 years)