Набор скоро начнётся NCT05824676

DePuy Synthes Variable Angle LCP Patella Plating System Study

Без фазы С лечением Trauma Patella Fracture Knee Cap Knee Cap Injury

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Variable Angle LCP Patella Plating System, Traditional Fixation.
Кому может быть актуально: Состояния в реестре: Trauma, Patella Fracture, Knee Cap, Knee Cap Injury. Базовые параметры: 18 лет — 74 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Utility of the Variable Angle LCP Patella Plating System for Traumatic Patellar Fractures: A Randomized Control Trial

Обзор

The Depuy Synthes Locking Compression Plate (LCP) Variable Angle Patella Plating System is an FDA approved device. The purpose of this study is to see how well the Depuy Synthes LCP Variable Plating System work in fixing a broken kneecap (patella). Depuy says that the device will improve healing when compared to traditional ways of repairing a broken patella. The goal of this randomized control trial is to learn how well the LCP Variable Plating System works to fix a broken patella (kneecap) compared to traditional fixation methods, in male and females, age 18 to 74, with a patellar fracture, and being treated at Hartford HealthCare The Bone and Joint Institute or Hartford Hospital. The main question it aims to answer are: * To understand if the Depuy Synthes LCP Variable Angle Plating System will provide a better way to help patients recover from a broken patella. Participants will evaluated at specific time points: post-op day 1, 6 weeks, 3 months, 6 months, and 12 month post-surgery. Participants will be asked to: * Complete surveys at all evaluation timepoints. * Have x-rays(radiographs) taken at the 6 week, 3 month, 6 month, 9 month, and 1 year timepoints. * Participants will have a passive range of motion tests done at 6 week, 3 month, 6 month, 9 month, and 1 year timepoints. * Participants would have strength and balance tests done at the 3 month, 6 month, 9 month, and 1 year timepoints.

Вмешательства

Устройство Variable Angle LCP Patella Plating System
FDA approved device, 510K number of, K210408. The Variable Angle LCP Patella Plating System is a device that can be formed to a patients specific need with various anchoring points to best fix what is needed for fixation.
Устройство Traditional Fixation
Traditional fixation methods for patellar fracture (screws, suture fixation, wire fixation, other plates).

Первичные конечные точки

DePuy Synthes LCP Variable Angle Patella Plating System clinical outcomes comparison [Срок оценки: 1 year]
DePuy Synthes LCP Variable Angle Patella Plating System functional outcomes comparison [Срок оценки: 1 year]
DePuy Synthes LCP Variable Angle Patella Plating System patient reported outcomes comparison [Срок оценки: 1 year]

Вторичные конечные точки (12)

Patient-Reported Outcomes Measurement Information System 10 Global (PROMIS 10 Global) [Срок оценки: Post-op day 1]
Patient-Reported Outcomes Measurement Information System 10 Global (PROMIS 10 Global) [Срок оценки: 6 weeks]
Patient-Reported Outcomes Measurement Information System 10 Global (PROMIS 10 Global) [Срок оценки: 3 months]
Patient-Reported Outcomes Measurement Information System 10 Global (PROMIS 10 Global) [Срок оценки: 6 months]
Patient-Reported Outcomes Measurement Information System 10 Global (PROMIS 10 Global) [Срок оценки: 9 months]
Patient-Reported Outcomes Measurement Information System 10 Global (PROMIS 10 Global) [Срок оценки: 1 year]
Activities of Daily Living-Knee Outcomes Survey (ADL-KOS) [Срок оценки: Post-op day 1]
Activities of Daily Living-Knee Outcomes Survey (ADL-KOS) [Срок оценки: 6 weeks]
Activities of Daily Living-Knee Outcomes Survey (ADL-KOS) [Срок оценки: 3 months]
Activities of Daily Living-Knee Outcomes Survey (ADL-KOS) [Срок оценки: 6 months]
Activities of Daily Living-Knee Outcomes Survey (ADL-KOS) [Срок оценки: 9 months]
Activities of Daily Living-Knee Outcomes Survey (ADL-KOS) [Срок оценки: 1 year]

Критерии участия

Критерии включения

Males and females
Age between 18 and 74 years old (inclusive)
Patellar fracture
Treated at Hartford HealthCare The Bone and Joint Institute or Hartford Hospital