NCT02766231进行中（未招募）不适用
A Multicentre, Prospective Study Evaluating Clinical, Radiographic and Patient-reported Outcomes of Total Knee Arthroplasty With Physica CR or Physica PS Prosthesis
Limacorporate S.p.a4 个研究点 分布在 3 个国家目标入组 157 人开始时间: 2016年2月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 157
- 试验地点
- 4
- 主要终点
- Clinical change in Knee Society Score (KSS)
研究概览
简要总结
Type & Design:
Post-market, international, multicentre Prospective, parallel groups, open-label, baseline controlled
Objectives:
- Assessment of clinical, radiographic and patient-reported outcomes of Physica CR and PS designs
- Incidence of adverse events and identification of possible risk factors for unsatisfactory results
- Mid-term survivorship of the implants
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 22 Years 至 78 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and females
- •Age 22-78 years
- •Ambulatory patients
- •Patients who have a medical condition with over 5 years of life expectancy
- •Patients with painful primary or secondary knee osteoarthritis
- •Patients who have undamaged and functional collateral and posterior cruciate ligaments for the group requiring Physica CR or Patients who have undamaged and functional collateral ligaments for the group requiring Physica PS
- •Patients with flexion ≥90° on the affected side
- •Patients with a fixed flexion contracture <20°
- •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
- •Previous partial knee replacement or patellofemoral joint replacement and previous patellectomy
- •Primary Total Knee Replacement (TKR) in the affected knee
- •Varus deformity >20° or Valgus deformity >15°
- •Patients with a fixed flexion contracture >20°
- •Previous intra-articular fractures of the affected knee
- •Patients with previous methaphysal tibial or femoral osteotomy performed less than 5 years before the screening visit, in case of plate removal surgery it is done early than 1 year ago to screening.
- •Previous knee replacement on the contralateral side within the last year and whose outcome is achieving an KSS< 60 points
- •Patients with symptomatic Osteoarthritis (OA) of the spine if the assessment of pain with Numeric Rating Scale is >4
- •Patients with an history of infections (on the affected knee or systemic)
- •Muscular insufficiency or absence of muscoligamentous supporting structures required for adequate soft tissue balance
- •Patients who have damaged or absence of the posterior cruciate ligament for the group requiring Physica CR
- •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 including:
- •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, drug or alcohol abuse
- •significant neurological or musculoskeletal disorders or disease that may adversely affect gait and compromise functional recovery
- •neuromuscular or neurosensory deficit which would limit the ability to assess the performance of the device
- •known metabolic disorders leading to progressive bone deterioration
- •Patients who have known co-existent 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
研究组 & 干预措施
Physica CR
Patients who have undamaged and functional collateral and posterior cruciate ligaments for the group requiring Physica CR
干预措施: Physica CR (Device)
Physica PS
Patients who have undamaged and functional collateral ligaments for the group requiring Physica PS
干预措施: Physica PS (Device)
结局指标
主要结局
Clinical change in Knee Society Score (KSS)
时间窗: From preoperative (baseline) to 5 years after surgery
KSS is divided into two components: the first ("Knee Score", KKSS) assesses the knee clinically through the physical examination, and the second ("Function Score", FKSS) assesses the individual's functionality, while both attain a total of 100 points each. The Clinical KSS (KKSS) evaluates pain (50 points), stability (25 points) and range of motion (25 points). The Functional KSS (FKSS) evaluates the walking distance (50 points), and the act of climbing and descending stairs (50 points). The system for selecting patients is provided through three categories: A- unilateral or bilateral (opposite knee replaced successfully), B- unilateral, other knee symptomatic and C- polyarthritis or clinical disease. Scores rating from 80 to 100 is considered excellent, from 70 to 79 good, from 60 to 69 fair, and less than 60 poor.
次要结局
- Functional change in Timed up and Go (TUG) test(From preoperative (baseline) to 5 years after surgery)
- Change in Knee injury and Osteoarthritis Outcome Score (KOOS)(From preoperative (baseline) to 5 years after surgery)
- Change in Satisfaction Visual Analogue Scale (Satisfaction VAS)(From 3 months to 5 years after surgery)
- Change in Forgotten Joint Score (FJS-12)(From 3 months to 5 years after surgery)
- Components stability - radiolucent lines evaluation(From discharge to 5 years after surgery)
- Survival rate of Physica CR and PS(At 3 years and 5 years after surgery)
- Incidence of device-related AE/SAE/DD/ADE/SADE(From intraoperative to 5 years after surgery)
研究者
研究点 (4)
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