Monocentric, Randomized Study, Comparing Articular Noise and Its Perception Between Two Different Types of Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Prevalence of articular noise
研究概览
简要总结
Some patients complain of articular noise (such as clicking, snapping, cracking or popping) after a total knee replacement. Controversy remains about whether there is a correlation between articular noise and worse outcomes following a knee replacement. A study by Nam et al. on 1540 patients revealed an association between noise and residual symptoms 30 days after they received a total knee replacement. Conversely, a study by Kuriyama et al. on 60 patients revealed no correlation between noise and patient satisfaction after 1 year of receiving a total knee replacement. The incidence of noise following a knee replacement has rarely been studied as a primary outcome. Like pain, it could be considered an important patient-reported outcome to assess patient satisfaction. The study aims to compare the prevalence of patient-perceived noise of an ultra-congruent total knee prosthesis (Score 2, Amplitude) versus a posterior-stabilized total knee prosthesis (Anatomic, Amplitude).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients receiving a primary TKA
- •Signed informed consent
- •Patients affiliated to a social security scheme
- •Patients willing and able to comply with study protocol requirements based on the investigator's judgment.
排除标准
- •History of knee surgery on the concerned/studied knee (except arthroscopic surgery)
- •Patients presenting coronal deformities > 20°, varus laxity > 10° and/or valgus laxity > 15°
- •Patients receiving revision TKA
- •Pregnancy or breast-feeding
- •Patients with protected status under articles L1121-6, LL121-8 and L1122-2 of the French Public Health Code
- •Unable to comply with study procedures, based on the investigator's judgment.
研究组 & 干预措施
UC TKA
The Score II® is a primary cruciate-sacrificing TKA, with a single-radius femoral component that articulates in an ultra-congruent (UC) mobile-bearing tibial insert. The mobile-bearing tibial insert has high anterior and posterior borders to avoid anterior subluxation of the femoral condyles during knee flexion and a concave articular surface with a radius of curvature that matches that of the femoral component in the sagittal plane to ensure high congruence. The Score II® UC TKA comprises eight sizes and offers the choice of using a cemented or uncemented version. In this study, only the cemented version will be used.
干预措施: total knee arthroplasty (Procedure)
PS TKA
The Anatomic® is a primary PS TKA with a fixed-bearing polyethylene insert. The femoral component has a cam design that engages on a tibial post to provide anterior-posterior stability during flexion. The Anatomic® PS TKA comprises nine cemented sizes. In this study, only the cemented version will be used. The Anatomic® PS TKA comprises nine cemented sizes.
干预措施: total knee arthroplasty (Procedure)
结局指标
主要结局
Prevalence of articular noise
时间窗: 2 years
The primary outcome is the prevalence of patients with articular noise at 2 years, evaluated by the Investigator during the follow-up visit through clinical examination and using the following question (Q1): Q1: Do you hear noise? Never, rarely, sometimes, often, extremely often
次要结局
- Noise characterisation: Type(1 and 2 years)
- Noise characterisation: Location(1 and 2 years)
- Noise characterisation: Discomfort(1 year and 2 years)
- Noise characterisation: impact on quality of life(1 and 2 years)
- Patient reported outcome score(1 and 2 years)