A Randomized Data Collection of the Maxim® Knee System With Removable Molded Polyethylene Tibia and the Regular Maxim® Knee System
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Knee Society Function Score
研究概览
简要总结
The purpose of this prospective clinical data collection is to compare the outcomes of two different tibial bearings: the Maxim® Pop-Top® Tibia and Maxim® Modular Tibia.
详细描述
The purpose of this prospective clinical data collection is to document and compare the performance and clinical outcomes between the Maxim® Knee System with Removable Molded Poly Tibia and the Maxim® Knee System with Modular Tibial Bearing as two treatment groups.
FDA has cleared these devices via Premarket Notification 510(k)'s K991753, K984623, K993159, K010027. The data gathered will be collated and used to provide feedback to designing engineers, support marketing efforts and answer potential questions from reimbursement agencies.
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
- 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
- •Identical to the indications stated in the FDA approved labeling for the device (cleared in 510(k) K991753,
- •K984623, K993159, K010027). These indications are stated below:
- •Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
- •Correction of varus, valgus, or posttraumatic deformity.
- •Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
- •Patient selection factors to be considered include:
- •need to obtain pain relief and improve function,
- •ability and willingness of the patient to follow instructions, including control of weight and activity level,
- •a good nutritional state of the patient,
- •the patient must have reached full skeletal maturity.
- •Porous coated knee joint replacement prostheses have not been approved for non-cemented applications in the United States.
排除标准
- •Identical to the contraindications stated in the FDA approved labeling for the device (cleared in 510(k) K991753, K984623, K993159, K010027's). These contraindications are stated below:
- •Absolute contraindications include:
- •infection,
- •osteomyelitis.
- •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.
研究组 & 干预措施
1
Maxim® Pop-Top® Tibia
干预措施: Maxim® Knee System with Removable Molded Polyethylene Tibia (Device)
2
Maxim® Regular Tibia
干预措施: Regular Maxim® Knee System (Device)
结局指标
主要结局
Knee Society Function Score
时间窗: 1 Year
The function score is detailed below as a Range; 100 being the highest score, and 0 being the lowest score. 90-100 is considered "Excellent," 60-89 is considered "Good," 30-59 is considered "fair," and 0-29 is considered "poor."
次要结局
- Range of Motion - Flexion(1 Year)