NCT06830603尚未招募不适用
A Post Market, Prospective Clinical Study Evaluating Clinical and Radiographic Outcomes of Patients Undergoing Total Knee Arthroplasty with Physica TT Tibial Plate
Limacorporate S.p.a0 个研究点目标入组 142 人开始时间: 2025年5月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 142
- 主要终点
- Change in Knee Society Score from preoperative to 2 years after surgery
研究概览
简要总结
This prospective clinical study aims at evaluating clinical, radiographic, patient-reported outcomes of total knee arthroplasty with Physica TT Tibial Plate over 2 years after surgery, in order to assess the performance and safety of the devices. Short-term survivorship of the implant and the incidence of early complications are evaluated.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient requiring a total knee arthroplasty (TKA) and suitable for receiving Physica TT Tibial Plate;
- •Age ≥ 18 years old;
- •Candidate for primary total knee replacement when clinical indications based on physical examination and medical history include one or more of the following conditions:
- •Non-inflammatory degenerative joint disease such as knee osteoarthritis, post traumatic knee arthritis;
- •Inflammatory degenerative joint disease such as rheumatoid arthritis;
- •Patient has well-preserved and well-functioning collateral ligaments
- •Patient is able to understand the conditions of the study, is willing and able to follow all prescribed rehabilitation as well as willing to perform all scheduled follow-up visits;
- •Patient has signed the study-specific Informed Consent Form prior to study activities
排除标准
- •Patient is affected by one or more of the conditions that are stated as Physica contraindications for use, which are:
- •Severe instability of the knee joint secondary to the absence of collateral ligament integrity and/or function.
- •Any active or suspected infection (local or systemic) or previous history of infection that may affect the prosthetic joint.
- •Significant bone loss on femoral or tibial joint side.
- •Known incompatibility or allergy to the product materials, and/or metal hypersensitivity to implant materials.
- •Septicaemia.
- •Persistent acute or chronic osteomyelitis.
- •Open epiphyses (immature patient with active bone growth).
- •Necrotic bone
- •Arterial vascular insufficiency or nerve diseases of the lower limbs severe enough to interfere with the study evaluation.
- •Compromised bone stock due to disease, infection or prior implantation that cannot provide adequate support and/or fixation to the prosthesis.
- •Systemic or metabolic disorders leading to progressive bone deterioration, which may impair fixation and stability of the implant.
- •Any concomitant disease and dependency that might affect the performance of the implanted prosthesis.
- •Important osteoporosis, haemophilic disease.
- •Internistic problems with high risk for surgery.
- •Previous partial knee replacement (unicompartmental, bicompartmental or patellofemoral joint replacement), patellectomy, high tibial osteotomy.
- •Affected by malignant cancer with life expectancy less than 2 years or where cancer treatment might affect the normal postoperative course.
- •Any clinically major pathology based on clinical medical history or any medical intervention or reason that the Investigator feels may affect the study evaluation.
- •Neurological or musculoskeletal disorder or disease that may adversely affect gait, functional recovery and evaluation.
- •Neuromuscular or neurosensory deficit that would hamper the performance assessment of the device.
- •Any psychiatric illness that would prevent comprehension of the details and nature of the study.
- •Simultaneously taking part in another surgical intervention study or pain management study that may affect with clinical study outcomes.
- •Female patient who is pregnant, nursing, or planning a pregnancy.
结局指标
主要结局
Change in Knee Society Score from preoperative to 2 years after surgery
时间窗: From preoperative to 2 years after surgery
0-100 scale. Scores rating from 80 to 100 are considered excellent, between 70 and 79 good, between 60 and 69 fair, and less than 60 poor
次要结局
- Change in Oxford Knee Score(From preoperative to 2 years after surgery)
- Change in Range of Motion(From preoperative to 2 years after surgery)
- Radiographic implant evaluation and stability assessment(From preoperative to 2 years after surgery)
- Incidence, type and severity of Adverse Device Effects (ADE) and Serious Adverse Device Effects (SADE)(From preoperative to 2 years after surgery)
- Implant survival rate(From preoperative to 2 years after surgery)
研究者
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