Anterior Knee Pain and Patellar Tendon Elasticity After Infrapatellar Tendon-Split Tibial Intramedullary Nailing
Relationship Between Anterior Knee Pain and Patellar Tendon Elasticity After Infrapatellar Tendon-Split Tibial Intramedullary Nailing: A Prospective Cohort Study Using Shear-Wave Ultrasound Elastography
Обзор исследования
Статус
Подробное описание
Anterior knee pain is a frequent complaint after tibial intramedullary nailing, but the role of patellar tendon biomechanical changes remains unclear. The infrapatellar tendon-split approach may lead to tendon healing, remodeling, and fibrosis, which could alter tendon elasticity and contribute to persistent pain and functional limitation. This study aims to prospectively investigate whether changes in patellar tendon elasticity are associated with anterior knee pain after infrapatellar tendon-split tibial intramedullary nailing.
This is a prospective, single-center, non-interventional observational cohort study. Adult patients aged 18 to 65 years with unilateral tibial shaft or metaphyseal fractures treated with standard infrapatellar tendon-split tibial intramedullary nailing will be enrolled consecutively after institutional ethics approval. Only patients enrolled after ethics approval will be included in the registered cohort.
Patellar tendon elasticity will be measured using shear-wave ultrasound elastography at four predefined time points: preoperatively, 6 weeks, 3 months, and 6 months postoperatively. Ultrasound assessments will be performed according to a standardized protocol by two independent radiologists, and inter-rater reliability will be assessed. Additional ultrasound parameters will include tendon thickness on B-mode imaging and Doppler neovascularization.
Clinical outcomes will include anterior knee pain assessed with a visual analog scale, patellofemoral function assessed with the Kujala Anterior Knee Pain Scale, tendon-related symptoms assessed with the VISA-P questionnaire, pressure pain sensitivity, and active knee range of motion. The primary objective is to determine whether change in patellar tendon elasticity is associated with anterior knee pain at 6 months. Secondary objectives are to examine associations between tendon elasticity and functional scores, range of motion, tendon thickness, Doppler findings, and inter-rater measurement reliability.
Тип исследования
Регистрация (Оцененный)
Контакты и местонахождение
Места учебы
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Istanbul
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Istanbul, Istanbul, Турция (Туркие), 34320
- Bagcilar Training and Research Hospital
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Метод выборки
Исследуемая популяция
Описание
Inclusion Criteria:
- Age 18 to 65 years
- Unilateral tibial shaft or metaphyseal fracture
- Planned treatment with infrapatellar tendon-split tibial intramedullary nailing
- Ability to complete baseline and follow-up assessments
- Written informed consent
Exclusion Criteria:
- Previous surgery on the same knee
- Previous patellar tendon rupture or known patellar tendon disorder
- Active inflammatory rheumatologic disease
- Chronic systemic corticosteroid therapy or long-term immunosuppressive treatment
- Significant peripheral neuropathy or advanced diabetic neuropathy
- Bilateral tibial fracture
- Additional major lower-extremity injury or surgery affecting assessment
- Inability to comply with scheduled follow-up visits
Учебный план
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
|---|---|
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Infrapatellar Tendon-Split Tibial Nailing Cohort
Adult patients with unilateral tibial shaft or metaphyseal fractures treated with standard infrapatellar tendon-split tibial intramedullary nailing after ethics approval.
Participants will be followed prospectively with shear-wave ultrasound elastography and clinical assessments at baseline, 6 weeks, 3 months, and 6 months.
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Standard-of-care tibial intramedullary nailing performed through an infrapatellar longitudinal patellar tendon split approach.
The procedure is not assigned by the protocol; only patients undergoing this routine surgical approach are observed.
Non-invasive shear-wave ultrasound elastography of the patellar tendon performed at predefined study visits using a standardized imaging protocol.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change in patellar tendon elasticity from baseline to 6 months
Временное ограничение: Preoperative baseline and 6 months postoperatively
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Patellar tendon elasticity measured by shear-wave ultrasound elastography in kilopascals.
The primary analysis will assess the longitudinal change from baseline to 6 months.
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Preoperative baseline and 6 months postoperatively
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change in patellar tendon elasticity from baseline to 3 months
Временное ограничение: Preoperative baseline and 3 months postoperatively
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Change in patellar tendon elasticity measured by shear-wave ultrasound elastography.
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Preoperative baseline and 3 months postoperatively
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Anterior knee pain severity
Временное ограничение: Baseline and postoperative 6 weeks, 3 months, and 6 months
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Anterior knee pain severity will be assessed using the Visual Analog Scale.
The Visual Analog Scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Higher scores indicate worse anterior knee pain.
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Baseline and postoperative 6 weeks, 3 months, and 6 months
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Patellofemoral function
Временное ограничение: Preoperative baseline, 3 months, and 6 months
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Patellofemoral function will be assessed using the Kujala Anterior Knee Pain Scale.
The scale ranges from 0 to 100 points, with higher scores indicating better patellofemoral function and fewer anterior knee symptoms.
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Preoperative baseline, 3 months, and 6 months
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Patellar Tendon-Related Symptoms and Function
Временное ограничение: Preoperative baseline, 3 months, and 6 months
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Patellar tendon-related symptoms and function will be assessed using the Victorian Institute of Sport Assessment-Patella questionnaire.
The questionnaire ranges from 0 to 100 points, with higher scores indicating fewer patellar tendon-related symptoms and better function
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Preoperative baseline, 3 months, and 6 months
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Active knee range of motion
Временное ограничение: Preoperative baseline, 6 weeks, 3 months, and 6 months
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Active knee flexion and extension lag measured with a goniometer.
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Preoperative baseline, 6 weeks, 3 months, and 6 months
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Patellar tendon thickness
Временное ограничение: Preoperative baseline, 6 weeks, 3 months, and 6 months
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Patellar tendon thickness measured on B-mode ultrasound.
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Preoperative baseline, 6 weeks, 3 months, and 6 months
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Doppler neovascularization
Временное ограничение: Preoperative baseline, 6 weeks, 3 months, and 6 months
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Semiquantitative Doppler neovascularization score.
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Preoperative baseline, 6 weeks, 3 months, and 6 months
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Pressure Pain Sensitivity
Временное ограничение: 6 weeks, 3 months, and 6 months
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Pressure pain sensitivity will be assessed by recording pain intensity during a standardized pressure pain assessment using the Visual Analog Scale.
The Visual Analog Scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Higher scores indicate greater pressure pain sensitivity.
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6 weeks, 3 months, and 6 months
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Inter-rater reliability of shear-wave elastography measurements
Временное ограничение: Baseline, 6 weeks, 3 months, and 6 months
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Agreement between two independent radiologists assessed using intraclass correlation coefficients.
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Baseline, 6 weeks, 3 months, and 6 months
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Соавторы и исследователи
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
Другие идентификационные номера исследования
- BEA-ORT-MYY-01
Планирование данных отдельных участников (IPD)
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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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