A Prospective, Multicenter, Randomised Study to Evaluate the Fixation of Cemented and Cementless Design of GMK-UNI Anatomical Knee Prosthesis.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 70
- 试验地点
- 10
- 主要终点
- Comparing the occurrence of radiolucency's lines
研究概览
简要总结
Unicompartmental knee arthroplasty (UKA) is the principal surgical alternative to the total knee arthroplasty (TKA) in patients with end-stage unicompartmental tibiofemoral osteoarthritis (OA) of the knee. The current comparative randomized study aims to evaluate the fixation of cemented and cementless designs of GMK-UNI unicompartmental knee prosthesis over a 5-year time period.
详细描述
The Primary objective is to compare the quality of fixation of cemented and cementless designs of GMK-UNI unicompartmental knee replacement at 2 years of follow-up.
The Secondary objectives include the evaluation of the patient improvement (subjective and objective) using the new Knee Society Score (KSS); the patient's anterior pain following UKA and any eventual patella-femoral disorder; Implant survival rate using the Kaplan Meier analysis; Post-op radiological findings and Adverse Events.
The Primary outcome aims to compare the occurrence of radiolucency's lines (both partial and complete) between the two study groups. Secondary outcomes include New KSS, OKS, Kaplan Meier analysis and stability and fixation of UNI prosthesis.
All patients who meet the inclusion criteria to take part in the current clinical study will be invited to participate before the surgery.
Subjects will be randomized during the screening; half of them will receive the cemented GMK-UNI anatomical UKA and the other half the cementless GMK-UNI anatomical UKA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Comparing the occurrence of radiolucency's lines
时间窗: 5 yrs
Compare occurrence of radiolucency's lines (both partial and complete)between the two study groups
次要结局
- Anterior Knee Pian Scale (Kujala score)(pre-op; 3months;1,2,3,5 yrs)
- Recording of adverse events(Throughout the study)
- New Knee Society Score(Pre-op:3months;1,2,3,5 yrs)
- Implant survival rate using Kaplan Meier analysis(5 yrs)
- Oxford Knee Score(Pre-op;3month;1,2,3,5yrs)
- Stability and fixation of unicompartmental prosthesis(5 yrs)