Evaluation of Two Surgical Strategies for Robotic Implantation of Total Knee Prostheses (Stryker), Cemented Versus Uncemented. Prospective, Randomized, Single-center, Multisite Non-inferiority Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Change from baseline in International Knee Society (IKS) function score at 12 Months
研究概览
简要总结
Total knee replacement surgery (TKA) is a treatment for advanced tibial-femoral osteoarthritis. This intervention is justified in case of significant discomfort and failure of medical treatment. It aims to replace the native internal and external femoro-tibial joints with a joint between a femoral implant and a tibial implant.
Implants can be cemented or cementless. The longevity of these implants depends among other things on the quality of the bone fixation of the implants. It is therefore essential that this fixation be evaluated. The advantages of an uncemented TKA are the preservation of bone stock, the absence of wear by cement debris and prolonged fixation thanks to osseointegration. These characteristics are all the more interesting in a young population.
Numerous studies have been carried out on the survival of TKA with and without cement. The results found are not unanimous and mainly concern the survival of the implants and the presence of radiological signs of loosening. In addition, no study has evaluated the results of TKA with or without cement implanted using robotic assistance. The precision provided by the robotic system could improve the results of these uncemented implants.
Very few studies are interested in the functional results according to the cementation or not of TKA. And most of these studies do not have a high level of methodological evidence.
We would like to prospectively evaluate the functional results, survival, as well as the rate of radiological border after TKA with or without cement posed with robotic assistance, in the short and medium term.
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
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of internal, external or global femorotibial knee osteoarthritis
- •Indication for first-line total knee arthroplasty
- •having given informed consent
- •Affiliated with a social security scheme
- •Patient being able to understand the objectives of the study and willing to comply with postoperative instructions.
排除标准
- •Patient with rheumatoid arthritis
- •Preoperative flexion less than 90 °
- •Prosthesis associated with an osteotomy
- •History of surgery on the operated knee, except arthroscopy
- •Poor bone quality assessed by the surgeon
- •Knee deformation greater than 10 ° preoperatively (HKA)
- •Pregnant or breastfeeding Women
- •Persons deprived of their liberty by a judicial or administrative decision, persons under psychiatric care, persons admitted to a health or social institution for purposes other than research
- •Adults subject to a legal protection measure
- •Patient already participating to another clinical trial that might jeopardize the current trial
结局指标
主要结局
Change from baseline in International Knee Society (IKS) function score at 12 Months
时间窗: Baseline and 12 months
The knee function will be evaluated using the delta of the IKS function score between baseline (before surgery) and 1 year after total knee arthroplasty, and compared between the 2 arms.
次要结局
- Change from baseline in IKS function score at 60 Months(Baseline and 60 months)
- Change from baseline in IKS objective score at 60 Months(Baseline and 60 months)
- Unsealing free survival at 60 months(60 months)
- Forgotten joint score at 12 Months(12 months)
- Forgotten joint score at 60 Months(60 months)
- Change from baseline in IKS objective score at 12 Months(Baseline and 12 months)
- Presence of progressive radiological border at 12 Months(12 months)