Идёт набор NCT06981039

Comparison of Patella Plating Versus Tension Band Wiring for the Treatment of Unstable Patellar Fractures

Без фазы С лечением Patella Fracture

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: Patella Anatomical Locking Plate, Tension Band Wiring.
Кому может быть актуально: Состояния в реестре: Patella Fracture. Базовые параметры: от 18 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: Гонконг
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

The WASP Trial (Wiring Versus Anterior Star Plate): Comparison of Patella Plating Versus Tension Band Wiring for the Treatment of Unstable Patellar Fractures: A Randomized Controlled Trial

Обзор

This study aims to compare the efficacy and safety of patella anatomical locking plate fixation versus tension band wiring in the treatment of patellar fractures.

Подробное описание

Patellar fractures are a common injury that can cause significant pain and disability. Conventional treatment options frequently include tension band wiring (TBW) with or without axial K-Wires or through cannulated screws. However, tension band wiring does have its issues, including implant prominence and frequent reoperation rates, especially for comminuted patella fractures.

More recently, plate fixation has become increasingly more prevalent in the past decade. Initially, this began with small fragment or mini-fragment plates; which progressed to mesh locking plates and now, anatomical locking patella plates. Biomechanical studies have shown greater loads to failure, less fracture gapping or fracture displacement with locking plate fixation compared to TBW. Its low profile construct and round edges may be more tolerable to patients and less prominent than TBW. Furthermore, another possible advantage of plate fixation is the avoidance of quadricep and patellar tendon insertion scarring, as they do not need to be dissected or passed through for fixation as in TBW. This is the first randomized controlled trial comparing anatomical locking plate fixation and conventional tension band wiring for patella fractures to be performed. This study aims to compare the efficacy and safety of these two methods in the treatment of patellar fractures.

Вмешательства

Устройство Patella Anatomical Locking Plate
Patients in the patella anatomical locking plate group will undergo internal fixation with an anterior locking plate and screw construct using the 2.7mm variable angle (VA) locking patella plating system (DePuy Synthes, Zuchwil, Switzerland)
Устройство Tension Band Wiring
Patients in the tension band wiring group will undergo open anatomical reduction and internal fixation with a tension band wire construct.

Первичные конечные точки

Region specific patient reported functional outcome scores - Knee Injury and Osteoarthritis Outcome Score (KOOS) [Срок оценки: At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months]
Tegner Lysholm Knee Score [Срок оценки: At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months]
Tegner Activity Scale [Срок оценки: At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months]

Вторичные конечные точки (3)

Radiographic outcomes [Срок оценки: At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months]
Incidence of Complications [Срок оценки: At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months]
Subjective Implant Impingement Questionnaire [Срок оценки: At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months]

Критерии участия

Критерии включения

Aged 18 years or older
Diagnosed with an isolated closed injury, displaced, unstable fracture with displacement >2mm (AO/OTA Classification 34-B and C with surgical indication)
Able to give consent