NCT02118272终止不适用
A Multicentre, Prospective Clinical Study Evaluating the Outcomes of a New Knee System with a Physiological Rollback Mechanism
Limacorporate S.p.a6 个研究点 分布在 2 个国家目标入组 156 人开始时间: 2014年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 156
- 试验地点
- 6
- 主要终点
- Knee Society Clinical Rating System (KSS)
研究概览
简要总结
The aim of this study is to assess the clinical, radiographic and patient-reported outcome measures (PROMs) after total knee replacement with Physica KR, define the survivorship of the implants and identify possible risk factors that may lead to failure.
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
- 22 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and females
- •Age 22-80 years
- •Ambulatory patients
- •Patients who have a medical condition with over 5 years of life expectancy
- •Patients requiring knee prosthesis, suitable for the use of Physica KR
- •Patients with painful primary knee osteoarthritis
- •Patients with painful secondary knee osteoarthritis
- •Patients who are suffering from inflammatory arthritis (e.g. rheumatoid arthritis)
- •Patients who have undamaged and functional collateral and posterior cruciate ligaments
- •Patients with a flexion greater than or equal to 90° on the affected side
- •Patients with a fixed flexion contracture less than 10°
- •Patients who understand the conditions of the study and are willing and able to comply with the prescribed rehabilitation and to perform all scheduled follow-up visits
- •Patients who have signed the Ethics Committee approved study-specific Informed Consent Form prior to the surgery
排除标准
- •Obese patients with BMI above 35 kg/m2 (severe obesity)
- •Previous partial knee replacement (unilateral, bicompartimental or patellofemoral joint replacement), patellectomy, high tibial osteotomy or femoral osteotomy in the affected knee
- •Primary Total Knee Replacement (TKR) in the affected knee
- •Varus or Valgus deformity greater than 20°
- •Patients with a fixed flexion contracture greater than 10°
- •Previous knee replacement on the contralateral side within the last year and whose outcome is achieving an KSS< 70 points
- •Patients with symptomatic OA of the hips, spine, ankles, if it can interfere with the evaluation of the target knee
- •Patients with active or any suspected infection (on the affected knee or systemic)
- •Muscular insufficiency or absence of muscoligamentous supporting structures required for adequate soft tissue balance
- •Patients with known or suspicious metal hypersensitivity
- •Recurrent medical history of severe allergic or immune-mediated reactions
- •Vascular insufficiency of lower limbs severe enough to interfere with the study evaluation
- •Current treatment or treatment within the previous 2 years before the screening visit for malignant and life-threatening non-malignant disorders
- •Any clinically significant pathology based on clinical history that the Investigator feels may affect the study evaluation
- •Any intercurrent chronic disease or condition that may interfere with the completion of the 5-year follow-up, such as liver disease, severe coronary disease, alcohol or drug abuse, disordered mental state, or other clinically significant condition
- •Patients who have significant neurological or musculoskeletal disorders or disease that may adversely affect gait and compromise functional recovery and evaluation
- •Patients who have neuromuscular or neurosensory deficit which would limit the ability to assess the performance of the device
- •Patients with systemic or metabolic disorders leading to progressive bone deterioration
- •Patients who have a medical condition with less 5 years of life expectancy
- •Previous organ transplant surgery
- •Any psychiatric illness that would prevent comprehension of the details and nature of the study
- •Participation in any experimental drug/device study within the 6 months prior to the screening visit
- •Female patients who are pregnant, nursing, or planning a pregnancy
结局指标
主要结局
Knee Society Clinical Rating System (KSS)
时间窗: From baseline to 5 year follow up
次要结局
- Survival rate of the implant(at 3 and 5 year follow-up)
- Oxford Knee Score (OKS)(From baseline to 5 year follow-up)
- Incidence of AE/SAE, ADE/SADE(From baseline to 5 year follow-up)
- Satisfaction Visual Analogue Scale (VAS)(From baseline to 5 year follow-up)
- Knee injury and Osteoarthritis Outcome Score (KOOS)(From baseline to 5 year follow-up)
- Forgotten Joint score (FJS)(From baseline to 5 year follow-up)
研究者
研究点 (6)
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