Randomized Controlled Clinical Outcomes of the Vanguard XP Bicruciate Knee System
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Number of Knees Reported as "Feels Normal" on a Single Assessment Numeric Evaluation (SANE)
研究概览
简要总结
Randomized Controlled Study to determine if preservation of ligaments provides increased functional ability post-operatively in comparison to traditional TKA which sacrifices soft tissue.
详细描述
Randomized Controlled Study to compare clinical and patient reported outcomes of the Vanguard XP Bicruciate Total Knee System to the Vanguard CR Knee System through 10 years of follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •cemented application of components
- •bilateral subjects randomized by knee
- •patients with pre-existing contralateral knee surgery
- •painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, or traumatic arthritis where one or more compartments are involved
- •correction of varus, valgus, or posttraumatic deformity
- •sufficient soft tissue surrounding the knee, including the Anterior Cruciate Ligament
排除标准
- •cementless application of components
- •BMI greater than or equal to 40
- •use of Anterior Stabilized Bearings
- •patients with severe pre-operative varus or valgus deformity greater than or equal to 15 degrees
- •correction or revision of previous joint replacement procedure on index knee
- •infection
- •osteomyelitis
- •Relative exclusion criteria:
- •uncooperative patient or patient with neurological disorders who is 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, including the anterior cruciate ligament
研究组 & 干预措施
Vanguard XP Bicruciate Knee System
153 patients receive Vanguard XP Bicruciate Knee System
干预措施: Vanguard XP Bicruciate Knee System (Device)
Vanguard CR Knee System
153 patients receive Vanguard CR Knee System
干预措施: Vanguard CR Knee System (Device)
结局指标
主要结局
Number of Knees Reported as "Feels Normal" on a Single Assessment Numeric Evaluation (SANE)
时间窗: 12 Months
Participants answered a Single Assessment Numeric Evaluation (SANE) which asked how they rated their knee function. A score of 100 indicates normal and anything below 100 indicates a percentage of normal function.
次要结局
- Number of Knees Reported as "Feels at Least 80% of Normal" on a Single Assessment Numeric Evaluation (SANE)(12 Months)
- Revisions/Removals(3 years)
- Modified Knee Society Score(12 months)
- Number of Knees With Which Participants Reported Being "Happy" or "Very Happy"(12 Months)