Comparison of Functional Results and Complications Between K-Wire Tension Band Fixation and Interosseous Suturing in Transverse Patellar Fractures: A Randomized Controlled Trial
Comparison of Functional Results and Complications Between K-Wire Tension Band Fixation and Interosseous Suturing in Transverse Patellar Fractures: A Randomized Controlled Trial.
A transverse patellar fracture is a break across the kneecap that can affect knee movement, walking, and daily activities. Surgery is often needed to restore the position of the broken bone and allow it to heal.
This study will compare two surgical techniques for treating transverse patellar fractures in adults: K-wire tension band wiring and transosseous suture fixation using No. 5 FiberWire. The purpose is to determine whether the two techniques differ in knee function, fracture healing, and the occurrence of complications.
Eligible adults with an acute, closed transverse patellar fracture will be randomly assigned to one of the two treatment groups. Participants will be followed for 12 months after surgery. Knee function will be assessed using the Bostman score, while other outcomes will include pain, knee range of motion, quadriceps muscle strength, fracture healing, and complications such as infection, hardware irritation, and the need for further surgery.
The findings may help improve understanding of the benefits and limitations of these two surgical techniques and support clinical decision-making for adults with transverse patellar fractures.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
Transverse patellar fractures can disrupt the extensor mechanism of the knee and impair knee function. Surgical treatment aims to restore the anatomical alignment of the patella, provide sufficient stability for fracture healing, and facilitate the recovery of knee movement and quadriceps function.
K-wire tension band wiring is a commonly used fixation technique for patellar fractures. It uses Kirschner wires and a tension band construct to stabilize the fracture. However, complications such as hardware prominence, soft-tissue irritation, infection, and the need for subsequent implant removal may occur.
Transosseous suture fixation is an alternative technique that uses sutures passed through bone tunnels to stabilize the fracture. High-strength sutures, such as No. 5 FiberWire, may provide fixation without leaving prominent metallic implants. Nevertheless, the functional outcomes and complication profiles of this technique compared with conventional K-wire tension band wiring require further evaluation.
This randomized controlled trial will compare these two surgical techniques in adults undergoing operative treatment for acute, closed transverse patellar fractures. The study will assess postoperative knee function and recovery, fracture healing, pain, range of motion, quadriceps muscle strength, and treatment-related complications during follow-up.
The study is intended to provide comparative clinical evidence regarding functional recovery, fracture union, and complications associated with the two fixation methods. The findings may help inform surgical decision-making and contribute to the selection of an appropriate fixation technique for patients with transverse patellar fractures.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
-
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Cairo Governorate
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Cairo, Cairo Governorate, Египет, 11252
- Ain Shams University Hospitals (Demerdash Hospital)
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Age ≥ 18 years.
- Acute (less than 2 weeks) closed transverse patellar fracture (AO/OTA 34-C1 or similar).
- Medically fit for surgery and anesthesia.
- Willing and able to provide informed consent and comply with the study follow-up requirements.
Exclusion Criteria:
- Age < 18 years.
- Open patellar fractures.
- Pathological fractures.
- Non-transverse fracture patterns (e.g., polar or stellate fractures).
- Previous ipsilateral knee surgery or significant knee arthritis.
- Associated major lower-limb trauma (e.g., ipsilateral femoral or tibial fracture).
- Neuromuscular disorders affecting the lower limb.
- Severe systemic illness contraindicating surgery.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Активный компаратор: K-wire Tension Band Wiring
K-wire tension band wiring for transverse patellar fracture fixation. |
Surgical fixation of an acute transverse patellar fracture using Kirschner wires (K-wires) and a tension band construct to stabilize the fracture and maintain reduction during bone healing. |
|
Активный компаратор: Transosseous Suture Fixation
Transosseous suture fixation using No. 5 FiberWire for transverse patellar fracture fixation. |
Surgical fixation of an acute transverse patellar fracture using transosseous bone tunnels and high-strength No. 5 FiberWire sutures to stabilize the fracture and maintain reduction during bone healing. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Functional Outcome Assessed Using the Böstman Patellar Fracture Score at 12 Months
Временное ограничение: 12 months after surgery
|
Functional outcome will be assessed using the Böstman Patellar Fracture Score, a validated scoring system for evaluating functional recovery following patellar fractures. The scale ranges from 0 to 30 points, with a minimum score of 0 and a maximum score of 30. Higher scores indicate better functional outcomes, whereas lower scores indicate poorer functional recovery. |
12 months after surgery
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Pain Severity Assessed Using the Visual Analog Scale (VAS)
Временное ограничение: 2 weeks, 6 weeks, 3 months, 6 months, and 12 months after surgery.
|
Pain severity will be assessed using the Visual Analog Scale (VAS), a 10-cm scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain severity and worse outcomes, whereas lower scores indicate less pain and better outcomes. |
2 weeks, 6 weeks, 3 months, 6 months, and 12 months after surgery.
|
|
Knee Range of Motion
Временное ограничение: 2 weeks, 6 weeks, 3 months, 6 months, and 12 months after surgery.
|
Knee range of motion will be assessed by measuring active knee flexion and extension using a standard goniometer. Measurements will be recorded in degrees (°). Knee flexion ranges from 0° to 140°, with higher flexion values indicating greater knee mobility and better functional recovery. Knee extension is assessed by measuring the degree of extension deficit, where 0° indicates full extension and higher deficit values indicate worse outcomes. |
2 weeks, 6 weeks, 3 months, 6 months, and 12 months after surgery.
|
|
Time to Fracture Union
Временное ограничение: Up to 12 months after surgery.
|
Time to fracture union will be assessed in weeks from the date of surgery until radiographic evidence of fracture union is achieved. Fracture union will be defined by radiographic evidence of bridging bone across at least three of the four cortices on orthogonal radiographic views, in conjunction with clinical evidence of healing. The minimum value is 0 weeks. Higher values indicate a longer time to fracture union and therefore a worse outcome, whereas lower values indicate faster fracture healing and a better outcome. |
Up to 12 months after surgery.
|
|
Incidence of Postoperative Complications
Временное ограничение: From the date of surgery through 12 months postoperatively.
|
Postoperative complications will be assessed by recording the occurrence of any complications following surgery, including surgical site infection, wound complications, implant-related complications (such as K-wire migration, wire breakage, or fixation failure), loss of fracture reduction, nonunion, delayed union, symptomatic hardware, and reoperation. The outcome will be recorded as a binary variable: 0 = No postoperative complications and 1 = At least one postoperative complication. The minimum value is 0 and the maximum value is 1. Higher scores indicate the occurrence of postoperative complications and therefore worse outcomes. |
From the date of surgery through 12 months postoperatively.
|
Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- ASU-PATELLA FRACTURE -RCT-2026
Планирование данных отдельных участников (IPD)
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Описание плана IPD
Individual participant data (IPD) will not be shared with other researchers. The study data will be used for the purposes of the planned statistical analyses, thesis preparation, and scientific publication. Only aggregate, de-identified results will be reported in publications and presentations. This decision is intended to protect participant confidentiality and privacy.
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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