Evaluation of a New Bi-Condylar Total Knee Prosthesis (TKP) With All-Ceramic Friction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Evaluation of clinical endpoint 1(Oxford score) at 12 months
研究概览
简要总结
The results of TKP (Total Knee Prosthesis) are satisfactory but do not reach those of THP (Total Hip Prosthesis) in terms of indolence and function. By using an all-ceramic friction torque, identical to that of the hip, the promotor of this Clinical Investigation expects to obtain an improvement in term of indolence, ability to perform heavy activities, knee stability and an improvement in the long-term survival of TKP, while at the same time, a decrease in the rate of re-intervention in young patients.
详细描述
The aim of this study is to evaluate the all-ceramic knee prosthesis, according to clinical and radiological criteria of usual follow-up of a TKP for knee osteoarthritis, at 12 months.
Evaluation of clinical and radiographic endpoints at 12 months:
- Clinical: functional scores (Oxford and International Knee Society IKS), pain (from 0 to 6, better to worse outcome), knee mobility in flexion and extension (degrees), frontal and sagittal stability (in degrees and mm), joint sounds, Forgotten Joint Score (FJS).
The scores are mostly qualitative and all of them will be globally evaluated by the investigator regarding to the patient status.
-Radiographic: X-rays of the front and profile of the prosthesis, positioning of the implants (angle, axis), existence of borders (bone cement, prosthesis cement), presence of osteolysis or any notable element.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Previously active adult under 70 years of age with disabling knee osteoarthritis resistant to medical treatments (anti-inflammatories, infiltrations, analgesics), with a frontal deformity < 10° for a primary implantation
- •Written informed consent by the patient
- •Patients affiliated to the French social security system
排除标准
- •Knee deformity > 10
- •Obesity (BMI > 30)
- •Inflammatory rheumatism
- •History of infection
- •Poor skin coverage at the knee joint
- •Known allergy to the materials used and/or anesthetic used in the surgery
- •Repeated falls, major neurological disorders, mental or neuromuscular disorders which can be a source of post-operative complications
- •Significant functional deficit of the collateral ligaments
- •Positive serum or urine pregnancy test for woman with child bearing potential. Pregnancy or within 48 hours post-partum or breast feeding women
- •Phobic patient refusing to have an MRI
- •Patient with a contraindication to have an MRI (active medical devices, metal implants, etc.)
- •Patient under legal protection
- •Patient participating in another Clinical Investigation
- •Post fracture osteoarthritis
- •Osteoporosis
- •Anatomical configuration not allowing the implant to be fixed (depending on size constraints)
- •Disabling comorbidity upon any resumption of physical activity
结局指标
主要结局
Evaluation of clinical endpoint 1(Oxford score) at 12 months
时间窗: 1 year
Clinical 1 : Oxford functional score : 12 (good) to 60 (bad) 12 questions (1 normal to 5 discomfort )
Evaluation of clinical endpoint 5 (Pain) at 12 months
时间窗: 1 year
Clinical 5: Pain : 0 to 6
Evaluation of clinical endpoint 2 (IKS score) at 12 months
时间窗: 1 year
Clinical 2 : International Knee Society (IKS) score : * objective component (symptoms) 25 points * subjective component: * expectation (pre or post surgery) 15 points * satisfaction 40 points * function 100 points
Evaluation of clinical endpoint 3 (Forgotten Joint score) at 12 months
时间窗: 1 year
Clinical 3 : Forgotten Joint Score (FJS) : 12 questions (0 normal to 4 discomfort ) = Total then FJScore = 100 - (Total x 25)
Evaluation of clinical endpoint 4 (Joint sounds) at 12 months
时间窗: 1 year
Clinical 4: Joint sounds : 5 questions, no score
Evaluation of clinical endpoint 6 (Knee mobility) at 12 months
时间窗: 1 year
Clinical 6: Knee mobility : Flexion (°) Extension (°)
Evaluation of clinical endpoint 7 (Knee stability) at 12 months
时间窗: 1 year
Clinical 7: Knee stability : Frontal (° and mm) Sagittal (° and mm)
Evaluation of radiographic endpoints at 12 months
时间窗: 1 year
Radiographic : X-rays of the front and profile of the prosthesis : positioning of the implants (angle, axis), existence of borders (bone cement, prosthesis cement), presence of osteolysis or any notable element.
次要结局
- Evaluation of clinical endpoint 1 (Oxford score) at 3 and 6 months and physical capabilities of the patient(3 and 6 months)
- Evaluation of clinical endpoint 2 (IKS score) at 3 and 6 months and physical capabilities of the patient(3 and 6 months)
- Evaluation of clinical endpoint 3 (FJ Score) at 3 and 6 months and physical capabilities of the patient(3 and 6 months)
- Evaluation of clinical endpoint 4 (Joint sounds) at 3 and 6 months and physical capabilities of the patient(3 and 6 months)
- Evaluation of clinical endpoint 5 (Pain) at 3 and 6 months and physical capabilities of the patient(3 and 6 months)
- Evaluation of clinical endpoint 6 (Knee mobility) at 3 and 6 months and physical capabilities of the patient(3 and 6 months)
- Evaluation of clinical endpoint 7 (Knee stability) at 3 and 6 months and physical capabilities of the patient(3 and 6 months)
- Evaluation of radiographic endpoints at 3 and 6 months and physical capabilities of the patient(3 and 6 months)
- Evaluation of fibrous tissue(1 year)
- Validation of the ancillary equipment used and the prosthesis surgical technique(1 year)