Physica TT Tibial Plate Prospective Study

Официальное название

A Post Market, Prospective Clinical Study Evaluating Clinical and Radiographic Outcomes of Patients Undergoing Total Knee Arthroplasty with Physica TT Tibial Plate

Обзор

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.

Первичные конечные точки

• Change in Knee Society Score from preoperative to 2 years after surgery [Срок оценки: From preoperative to 2 years after surgery]

Вторичные конечные точки (5)

• Change in Oxford Knee Score [Срок оценки: From preoperative to 2 years after surgery]
• Change in Range of Motion [Срок оценки: From preoperative to 2 years after surgery]
• Radiographic implant evaluation and stability assessment [Срок оценки: From preoperative to 2 years after surgery]
• Incidence, type and severity of Adverse Device Effects (ADE) and Serious Adverse Device Effects (SADE) [Срок оценки: From preoperative to 2 years after surgery]
• Implant survival rate [Срок оценки: From preoperative to 2 years after surgery]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06830603 · K-41

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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