Total Knee Arthroplasty Randomized Clinical Trial- Cemented vs. Cementless Tibial Prosthesis Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- To use clinical outcome measures to assess for differences in patient function, quality of life and satisfaction between patients who have tibial component placement with either a cemented or a cementless technique
研究概览
简要总结
The primary purpose of TKA Randomized Clinical Trial- Cemented versus Cementless Tibial Prosthesis Study will determine whether there is a significant difference in patient-reported and measured clinical outcomes (e.g. pain, function, length of recovery, and patient satisfaction) between subjects treated with a cementless tibial prosthesis (the cementless group) and those treated with cemented tibial prosthesis (the cement group) over the first two postoperative years. Radiographs will be assessed before surgery and at established post-operative intervals to determine if there are any significant differences between patients in the two groups and to assess the influence of component fixation on radiographic stability over time. Complication and revision rates will also be assessed for comparison.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI less than <35
- •Normal neurological function
- •Primary total knee arthroplasty (Pre operative Medial Knee Patient)
- •Patient age ≤ 70 years old
排除标准
- •Revision surgery
- •History of joint sepsis
- •Recent systemic corticosteroids (< 2 months prior to procedure)
- •Primary or secondary carcinoma in the last five years
- •Post operative renal transplant
- •Psychosocial disorders limiting rehabilitation
- •Previous intraarticular knee fracture
- •Over 20° valgus or varus deformity
- •Extension loss over 20°
- •Unsuitable for cruciate- substituting arthroplasty
- •Unsuitable for cementless fixation of the tibial component
- •Need for augmentation wedges or bone graft
- •Previous proximal tibial osteotomy
研究组 & 干预措施
Cemented Tibia
Assessing the clinical outcomes of the different type of fixation
干预措施: Cemented Tibia (Procedure)
Cementless Tibia
Assessing the clinical outcomes of the different type of fixation
干预措施: Cementless Tibia (Procedure)
结局指标
主要结局
To use clinical outcome measures to assess for differences in patient function, quality of life and satisfaction between patients who have tibial component placement with either a cemented or a cementless technique
时间窗: 2014
次要结局
未报告次要终点