Monocentric, Randomized Study, Comparing Articular Noise and Its Perception Between Two Different Types of Individualized Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 210
- 主要终点
- Do you hear noise originating from your knee?
研究概览
简要总结
Knee osteoarthritis is a degenerative joint disorder leading to pain and limited movement. Total knee arthroplasty (TKA) has transformed the treatment of knee osteoarthritis, resulting in long-term outcomes that enhance the quality of life for patients. Some individuals report experiencing noise after undergoing TKA. However, there are few randomized controlled trials that assess postoperative noise following the procedure. Additionally, no research has been conducted on individualized TKA, which involves custom-made prostheses tailored to a patient's knee shape. This study aimed to compare the incidence of noise reported by patients who undergo a primary individualized TKA using either cruciate-retaining or posterior-stabilized designs.
详细描述
Articular noise is common after total knee arthroplasty (TKA), yet there is ongoing debate regarding its effect on postoperative outcomes, joint awareness and patient satisfaction. A comparative study on articular noise in 50 patients undergoing bilateral TKA using two different prosthesis designs reported that an ultra-congruent design generated less noise than a posterior-stabilized design (18% compared with 38%; p= 0.026), but there were no differences in patient preference, satisfaction, or Forgotten Joint Score (FJS) at two-year follow-up. A retrospective analysis of 160 robot-assisted and 320 conventional TKA revealed no difference in the prevalence of articular noise (40.7% vs 38.1%; p=0.647), but patients who complained of noise had lower FJS (45.5 vs 66.1; p<0.001) and lower Knee Injury and Osteoarthritis Score Joint Replacement (KOOS-JR) scores (72.0 vs 81.4; p<0.001) at one-year follow-up.
Recent advancements have shifted medicine from standardised approaches to personalised or precision medicine, tailoring treatments and decisions for individual patients based on their specific responses and risk factors. Individualized TKA adapts features to align with pre-arthritic anatomy and restore native movement, often utilising various tools. Recent studies on individualized TKA have demonstrated promising outcomes regarding personalised coronal alignment targets, correction of extra-articular deformities, intra-operative workflow, accommodation of the third compartment, and patient satisfaction rates.
This study will compare a posterior-stabilised (PS) and a cruciate-retaining (CR) individualized TKA implant. The PS implant is selected for patients with a damaged or a non-functional posterior cruciate ligament. In this case, the ligament is removed and substituted with a post-cam mechanism that aids femoral rollback during knee flexion and avoids anterior femoral subluxation. In contrast, the CR implant design can be selected for patients with an intact and functional posterior cruciate ligament. In this case, the ligament is retained, allowing it to guide femoral rollback and prevent anterior subluxation.
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
- 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 elective primary TKA as a treatment for osteoarthritis
- •with an intact and functional posterior cruciate ligament
- •with no previous knee surgery, on the ipsi- or contra-lateral knee
- •who signed the informed consent and are willing to comply with the protocol requirements based on the investigator's judgment.
- •affiliated with a social security scheme
- •with an ability to answer questionnaires and to communicate freely in French.
排除标准
- •that underwent previous knee surgery, except arthroscopic surgery, on their ipsilateral knee
- •with coronal deformities >20°
- •that are pregnant
- •any contraindication mentioned in the instructions for use of the medical devices under investigation
- •with protected status under articles L1121-6, LL121-8 and L1122-2 of the French Public Health Code
- •with other significant disease or disorder which, in the opinion of the investigating surgeon, may put the participant at risk because of participation in the study, or may influence the result of the study
- •who cannot comply with the protocol requirements based on the investigator's judgment.
结局指标
主要结局
Do you hear noise originating from your knee?
时间窗: 2 years
The surgeon will ask the blind participant whether they hear articular noise originating from their knee two years after TKA.
次要结局
- What part of the knee is involved?(1 & 2 years)
- What is the impact of the noise on your quality of life, on a scale from 0 (none) to 10 (severe)?(1 & 2 years)
- Do you feel noise?(1 & 2 years)
- Is the noise a concern or causing discomfort?(1 & 2 years)
- What kind of noise do you hear of feel?(1 & 2 years)