A Randomized Prospective Level 1 Comparison of a Modular Polished Fixed-Bearing Tibial Baseplate and an All-Polyethylene Tibia in Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Clinical and Functional Outcomes Based on Standardized Validated TKA Outcome Instruments (KSS, KOOS, WOMAC, SF-36)
研究概览
简要总结
This study is designed to compare prospectively, in a randomized Level 1 evidence fashion, the clinical, functional, and radiographic results of a modular polished tibial (MPT) tray with a moderately cross-linked polyethylene (XLK) insert to an all-polyethylene tibial (APT) design with GVF polyethylene. Comparing these two designs will afford us information in the following areas:
- Does a MPT/XLK design have improved wear characteristics over a nonmodular APT/GVF design?
- Is there a clear clinical advantage to the MPT/XLK design in certain patient populations that justify its use over the APT/GVF design?
Answering these questions will allow surgeons to use both designs appropriately in different demand populations.
This study is designed to address the questions of whether an MPT/XLK design offers improvement in wear characteristics, Knee Society scores, KOOS, WOMAC, SF-36, or radiographic measures, over an APT design. The investigator's primary hypothesis is that there will be no difference in these outcome measures at a minimum two year follow-up. A secondary hypothesis based on the long-term follow-up of this group, up to twenty years, is that there will be no difference in implant survival.
详细描述
Summary is detailed
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
- 60 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •generally accepted clinical and radiographic criteria for total knee arthroplasty
排除标准
- •Significant angular or bony deformity necessitating structural bone grafting or more extensive modular designs will be excluded at the discretion of the principle investigator
- •Routine contraindications to TKA (active sepsis, Charcot arthropathy)
- •Patients whose mental function preclude them from responding to our standard questionnaires
结局指标
主要结局
Clinical and Functional Outcomes Based on Standardized Validated TKA Outcome Instruments (KSS, KOOS, WOMAC, SF-36)
时间窗: 2 year follow-up intervals up to 20 years
Patient recorded outcome measures as noted
次要结局
- Wear Characteristics of the Standard GVF Polyethylene vs. the Moderately Cross-linked XLK Polyethylene(2 year followup intervals to 20 years)
研究者
Terence J. Gioe, M.D.
Chief of Orthopaedic Surgery
Minneapolis Veterans Affairs Medical Center
