Physica System Total Knee Replacement Registry Study

Официальное название

Post-market Registry Study on the Physica System Total Knee Replacement

Обзор

The primary objective of this study is to obtain long-term implant survivorship (out to 10 years) and to assess clinical, patient-reported outcome measures, and radiographic data for the commercially available Physica system. For ancillary arm, from baseline to 5-year follow-up.

Подробное описание

This is a post-market registry study; the study device is FDA cleared and used according to the intended use.

This is a multi-centre, prospective, non-randomized study.

Subjects will be implanted with one of the following configurations of the Physica system: Physica KR (Kinematic Retaining), Physica CR (Cruciate Retaining) or Physica PS (Posterior Stabilized). The assignment of any patient involved in the study is determined by the aetiology preoperatively evaluated by the Investigator and falls within current practice. The decision to use a specific prosthesis design is decided by the Investigators independently and clearly separated from the decision to include the patient in the study.

For the ancillary subgroup, investigators currently contributing to the primary patient group can also enroll additional patients to the ancillary subgroup. 3 existing sites and 2 additional sites are planned to be added to contribute to the additional 300 patients to be enrolled. These patients will follow the same study schedules as the main study, but follow-up is only up to 5 years.

Baseline measurements (pre-operative clinical analysis and radiographic analysis at 6-week FU) will serve as internal control term during the assessment of post-surgery data out to 10 years.

Вмешательства

• Устройство Physica Kinematic Retaining Knee System
  Modular total knee prosthesis with a Kinematic Retaining mechanism and posterior cruciate ligament (PCL) preservation
• Устройство Physica Cruciate Retaining Knee System
  Total knee prosthesis with posterior cruciate ligament (PCL) preservation
• Устройство Physica Posterior Stabilized Knee System
  Total knee prosthesis that sacrifices the posterior cruciate ligament (PCL) and replaces the functionality of the PCL with a post-cam mechanism.
• Устройство Physica Cruciate Retaining Knee System with LMC Liner
  Total knee prosthesis with posterior cruciate ligament (PCL) preservation

Первичные конечные точки

• Implant Survivorship [Срок оценки: 10 years]

Вторичные конечные точки (3)

• American Knee Society Score (KSS) 2011 [Срок оценки: 10 years]
• Patient-Reported Outcome Measures (PROMs) [Срок оценки: 10 years]
• Radiographic Evaluation [Срок оценки: 10 years]

Критерии участия

Критерии включения

• Males and females of any race requiring a total knee replacement and suitable for the use of one of the configurations of the Physica system
• Age> 22 (skeletally mature)
• Patients who are suffering from non-inflammatory degenerative joint disease (NIDJD):

including knee osteoarthritis, post-traumatic knee arthritis; or patients who are suffering from inflammatory arthritis; or patients that need correction of a functional deformity

• Suitable candidates for TKR who have undamaged and functional collateral ligaments
• Suitable candidates for TKR with Physica KR, CR, who have an undamaged and functional posterior cruciate ligament; or Physica LMC with or without a functioning posterior cruciate ligament or Physica PS with an absent or not-functioning posterior cruciate ligament and/or severe antero-posterior instability of the knee joint
• 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

Критерии исключения

• 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 (unicompartimental, bicompartimental 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 non-malignant disorders
• Patients with known incompatibility or allergy to the product materials, and/or metal hypersensitivity to implant materials
• 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

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 5 центров

• Eisenhower Desert Orthopedics Center - Harry and Diane Rinker Bldg — Rancho Mirage
• The Orthopedics Clinic — Daytona Beach
• Rush Castle Orthopaedics — Aurora
• Syracuse Orthopedic Specialists — Syracuse
• Joint Reconstructive Specialist — Oklahoma City

Идентификаторы

NCT: NCT03048201 · K-11

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗