The Effect of Three Prosthesis Designs on Implant Stability and Survival, Knee Function, and Clinical Course in Knee Arthroplasty: a Randomized Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 216
- 试验地点
- 4
- 主要终点
- Knee injury and osteoarthritis outcome score (KOOS)
研究概览
简要总结
The purpose of this study is to compare three prosthesis designs to compare three prosthesis designs for total knee arthroplasty and determine the best option for patients in need of a knee replacement.
详细描述
Total knee arthroplasty (TKA) is a cost beneficial surgery shown to improve pain, function and quality of life in patients with osteoarthritis. In 2015, 6093 patients received primary TKA in Norway. Despite the procedure´s general success, 20% of patients report persistent postoperative pain and/or dissatisfaction with the surgical outcome. Efforts to further improve the procedure have raised considerable debate regarding the role and management of the posterior cruciate ligament (PCL). Prostheses for TKA have evolved into designs that either preserve or sacrifice the PCL. In patients with a functional PCL, the decision of which design is selected depends largely on the favor and training of the surgeon. To further improve TKA patient outcomes, a better understanding of the role of these differing PCL treatments is needed. Thus, the aim of this study is to determine whether patients' perceived outcome, implant stability and clinical outcome differ between 3 TKA implant designs (2 PCL-sacrificing and 1 PCL-retaining). We will conduct a 3-arm randomized controlled prospective trial with 5-year follow-up. This study will have impact on clinical practice by addressing the lack of evidence supporting use of these different types of implants.
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
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary osteoarthritis
- •Non-fixed or fixed varus or valgus deformity less than 15º measured on preoperative standing hip-knee-ankle (HKA) radiographs
- •Intact PCL (assessed preoperatively and verified during surgery)
- •Age 45 - 75 years (only patients 45 - 70 years will be included in the kinematic RSA)
- •Body mass index ≤ 35 kg/m2
- •ASA (American Society of Anaesthesiologists) score I or II
- •Only patients with KOOS scores above 80 on the Symptoms, ADL (Activities of Daily Living) and Pain subscales will be included in the kinematic analysis
排除标准
- •Prior ACL (anterior cruciate ligament) surgery
- •Impaired collateral ligaments
- •Secondary osteoarthritis of the knee
- •Previous osteotomy
- •Rheumatic disease
- •Flexion less than 90 degrees
- •Flexion contracture over 10 degrees
- •Peripheral neuropathy
- •Malignancy
- •Patients who do not speak Norwegian
结局指标
主要结局
Knee injury and osteoarthritis outcome score (KOOS)
时间窗: Pre-operative, 1, 2 and 5 years
KOOS is a knee-specific questionnaire developed to evaluate short- and long-term symptoms and functioning in subjects with knee injury and osteoarthritis. KOOS is validated for use in total knee arthroplasty and has been shown to be a valid, reliable and responsive measure. KOOS is a patient-administered questionnaire.
次要结局
- Kinematic radiostereometric analysis (RSA)(After 12 months)
- Plain anterior posterior radiographs and hip, knee and ankle (HKA) radiographs(Pre-operative, 3, 12, 24 and 60 months)
- Brief Pain Inventory(Pre-operative, 6 weeks, 3, 12, 24 and 60 months)
- Oxford knee score (OKS)(Pre-operative, 1, 2 and 5 years)
- EQ-5D-5L(Pre-operative, 1, 2 and 5 years)
- Range of motion (ROM)(Pre-operative, 6 weeks, 3, 12, 24 and 60 months)