NCT04594447终止不适用
A Post-market,monocentric,randomised,open-label,parallel Group,prospective Clinical Study Evaluating the Functional Outcome of the Kinematic Physica KR Total Knee Replacement System Vs the Standard Physica CR Total Knee Replacement System
Limacorporate S.p.a1 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2021年9月30日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Oxford Knee Score (OKS)
研究概览
简要总结
Post-market, monocentric, randomised, open-label, parallel group, prospective study conducted in patients who have to perform a total knee replacement (TKR) with Physica KR or Physica CR system.
详细描述
The aim of the study is to evaluate the clinical, radiographic and PROMs outcomes of Total Knee Arthroplasty (TKA) with 2 Lima TKR design: Physica KR and Physica CR (randomization 1:1) from preoperative to 1-year follow-up.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females of any race requiring a total knee replacement and suitable for the use of one of the two configurations of the Physica system.
- •Age ≥ 18 years old,
- •Patients who are suffering from non-inflammatory degenerative joint disease (NIDJD): including knee osteoarthritis, post-traumatic knee arthritis, avascular necrosis; or patient who are suffering from inflammatory joint disease including rheumatoid arthritis.
- •Suitable candidates for TKR who have undamaged and functional collateral ligaments
- •Suitable candidates for TKR with Physica KR and CR who have an undamaged and functional posterior cruciate ligament.
- •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/IRB approved study-specific Informed Consent Form prior to the surgery.
排除标准
- •Patients with severe instability of the knee joint secondary to the absence of collateral ligament integrity and/or function.
- •Patients with active or any suspected infection (on the affected knee or systemic)
- •Previous partial knee replacement (unicompartmental, bicompartmental or patellofemoral joint replacement), patellectomy, high tibial osteotomy
- •Patients with significant bone loss on femoral or tibial joint side
- •Current treatment for malignant and/or life-threatening nonmalignant disorders
- •Patients with known incompatibility or allergy to the product materials, and/or metal hypersensitivity to implant materials
- •Patient with open epiphyses (immature patient with active bone growth).
- •Vascular insufficiency of lower limbs severe enough to interfere with the study evaluation
- •Patients with bone stock compromised by disease, infection or prior implantation that cannot provide adequate support and/or fixation to the prosthesis
- •Patients with systemic or metabolic disorders leading to progressive bone deterioration which may impair fixation and stability of the implant
- •Any concomitant disease and dependence that might affect the performance of the implanted prosthesis
- •Any clinically significant pathology based on clinical history that the Investigator feels may affect the study evaluation (e.g. primary osteoporosis with significant bone loss, haemophilic disease, septicaemia, persistent acute or chronic osteomyelitis)
- •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
- •Previous history of infection in the affected joint and/or other local/systemic infection that may affect the prosthetic joint
- •Any psychiatric illness that would prevent comprehension of the details and nature of the study
- •Patients currently participating in any other surgical intervention studies or pain management studies
- •Female patients who are pregnant, nursing, or planning a pregnancy.
研究组 & 干预措施
Physica CR
Other
Subject that receive Physica Cruciate Retaining total Knee replacement system
干预措施: Physica Cruciate Retaining knee replacement (Device)
Physica KR
Other
Subject that receive Physica Kinematic Retaining total Knee replacement system
干预措施: Physica Kinematic Retaining knee replacement (Device)
结局指标
主要结局
Oxford Knee Score (OKS)
时间窗: Baseline to 1 year FU
Changes of the Oxford Knee Score (OKS) from preoperative (baseline) to 1 year after the implant of the Physica KR compared to Physica CR designs. Specifically designed and developed to assess function and pain after TKR surgery. Responses to each question ranges from 0-4 with a range of a possible overall score from 0-48. A score of 0 is the worst possible outcome while a score of 48 is the best possible outcome.
次要结局
- Range of Motion (ROM)(Baseline to 1 year FU)
- 40 metre fast paced walk test(Baseline to 1 year FU)
- 30-second Chair Stand Test (30 CST)(Baseline to 1 year FU)
- Serious Adverse Event (SAE) incidence(Baseline to 1 year FU)
- Medical Outcomes Survey Short Form-36 (SF-36) RAND SF-36(Baseline to 1 year FU)
- Knee Society Score (KSS)(Baseline to 1 year FU)
- Adverse Event (AE) device related incidence(Baseline to 1 year FU)
- Knee injury and Osteoarthritis Outcome Score (KOOS)(Baseline to 1 year FU)
- Forgotten Joint Score (FJS)(Baseline to 1 year FU)
- Radiographic evaluation(Baseline to 1 year FU)
研究者
研究点 (1)
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