Prospective Post-market Study Examining the Effectiveness of the EcoFit®

Официальное название

Prospective Post-market Study Examining the Effectiveness of the EcoFit® Total Hip System With Implacross® E Polyethylene

Обзор

The purpose of this study is to evaluate the safety and effectiveness of the EcoFit Hip with implacross E polyethylene for total hip replacement surgery.

Подробное описание

This study will assess the performance and success rate of the EcoFit Total Hip System. Survivorship and clinical outcomes will help determine implant success 36 months as defined by specific scoring systems and compared to other published data.

Вмешательства

• Устройство EcoFit® Total Hip System with implacross® E Polyethylene
  The EcoFit® Total Hip System is a primary hip replacement system indicated for patients who are candidates for a primary cementless hip replacement. implacross® E Polyethylene is one of the components in the EcoFit® system.

Первичные конечные точки

• Survival of the EcoFit Hip with implacross E polyethylene for total hip replacement surgery [Срок оценки: 36 months]

Вторичные конечные точки (3)

• Evaluate the pre to post-op change in the Harris Hip Score [Срок оценки: Pre-op, 6 months, 12 months, 24 months, 36 months]
• Evaluate the pre to post-op change in the WOMAC Score [Срок оценки: Pre-op, 6 months, 12 months, 24 months, 36 months]
• Device related complications [Срок оценки: Through completion of study, an average of 3.5 years]

Критерии участия

Критерии включения

• Subject must be a candidate for a total primary hip replacement.
• Subject must have degenerative joint disease, including osteoarthritis or traumatic arthritis, OR a femoral fracture which can be treated by a primary hip replacement and no other hardware
• Subject has a BMI of 40.00 kg/m2 or less at the time of enrollment
• Subject is likely to be available for evaluation for the duration of the study
• Subject is able and willing to sign the informed consent and follow study procedures
• Subject is not pregnant

Критерии исключения

• Subject has had a prior hip replacement in the subject hip
• Subject has an active cancer or is a survivor for <5 years except for squamous cell or basal cell skin cancer
• Subject has a chronic disease(s) where, in the opinion of the investigator, the disease will interfere with the patient's ability to follow the protocol
• Subject is currently a documented substance abuser (alcohol or other addictions)
• Subject has an infection, or history of infection (within the last 3 months), acute or chronic, local or systemic
• Subject has a history of muscular, neurological or vascular deficiencies which compromise the affected extremity
• Subject has a BMI > 40.00 kg/m2
• Subject has a mental condition that may interfere with the subject's ability to give an informed consent or willingness to fulfill the study requirements (i.e., severe mental retardation such that the Subject cannot understand the informed consent process, global dementia, prior strokes that interfere with the Subject's cognitive abilities, senile dementia, and Alzheimer's Disease)
• Subject is a prisoner
• Subject is pregnant
• Subject has known materials sensitivity (to metals)

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT04918680 · EcoFit® Post-market Study

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗