Microplasty Tibial Tray Multi-Center Data Collection
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Knee Society Score
研究概览
简要总结
The purpose of this prospective clinical data-collection is to document the performance and clinical outcomes of the Microplasty Tibial Tray.
详细描述
FDA has cleared this device via premarket notification 510(k) K063732. By being CE Marked, the Microplasty Tibial Tray also conforms to the essential requirements of EC Directive 93/42/EEC; in accordance to 13485:2003. The data gathered would be collated and used to provide feedback to design engineers, support marketing efforts, and answer potential questions from reimbursement agencies, and will serve as a part of Biomet's Post Market Surveillance System.
Inclusion/exclusion criteria are identical to those indications and contraindications stated in the FDA approved labeling for the device in 510(k) K063732 Surgical techniques and patient care are to be standard for the surgeon participating in the protocol and should be maintained the same throughout the course of the data-collection. There will be no experimental or investigational devices used. There will be no experimental or investigational surgical techniques used. The devices and products will be used in accordance with their instructions for use and/or approved labeling. Any use of the device or collection of clinical data outside of the United States should comply with all local, state, and/or national and international regulations.
Function will be assessed through the Knee Society Score . Survivorship will be documented by asking the surgeon to document revisions and complications.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The inclusion criteria will be identical to the indications stated in the FDA approved labeling for the device in 510(k) K
- •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, and
- •The patient must have reached full skeletal maturity
- •Non-coated (Interlock®) devices are indicated for cemented application only.
排除标准
- •The exclusion criteria will be identical to the contraindications stated in the FDA approved labeling for the device in 510(k) K
- •These contraindications are stated below:
- •Absolute contraindications include: infection, sepsis, and 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.
- •Biomet Microplasty™ Tibial Trays are contraindicated for use with constrained bearings.
结局指标
主要结局
Knee Society Score
时间窗: 5 years
次要结局
- Radiographic Data(10 Years)