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Набор по приглашению NCT06389240

Early Weight Bearing in Unicondylar Tibial Plateau Fractures

— Наблюдательное Early Mobilization

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: 6 weeks post-operatively early weight bearing, 10 weeks post-operatively weight bearing (standard of care).
Кому может быть актуально
Состояния в реестре: Early Mobilization. Базовые параметры: 18 лет — 65 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
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Официальное название

Early Weight Bearing in Unicondylar Tibial Plateau Fractures: How Does it Affect Gait Pattern, Mobility and Overall Outcome: A Randomized Controlled Trial

Обзор

The investigators aim of the study is to assess the effects of early mobilization after surgically treated unicondylar tibia plateau fractures (6 weeks without weight bearing) on gait, patient satisfaction, return to work/sports and complication rate. The data will be compared to a 10-12 week non-weight bearing group (standard of care). It is assumed that earlier mobilization does not lead to an increase in the complications - in particular osteosynthesis failure and infections -, but leads to improved patient satisfaction, reduced return to work/sports times, and has a positive impact on the overall outcome

Подробное описание

Tibial plateau fractures are common sports injuries caused by accidents such as skiing and mountain biking. Thus, young adults with high functional and athletic demands are often affected. The best possible restoration of the original joint function and resilience is therefore particularly important for this group of patients. In addition, prolonged immobilization in this patient group poses a high risk of loss of earnings and a significant impairment in athletic performance.

These injuries usually require surgical treatment which is followed by 10-12 weeks without weight bearing. In recent years, there has been a shift towards earlier mobilization with many injuries. In addition, numerous studies showed the negative effects of prolonged immobility. Nevertheless, these negative effects must always be weighed against the possibility of osteosynthesis failure.

Вмешательства

  • Другое 6 weeks post-operatively early weight bearing
    Early mobilization 6 weeks post-operatively. Gait analyses is carried out on when full mobilization is allowed. Gait analysis is performed while using force-measuring insoles (loadsol, Novel).
  • Другое 10 weeks post-operatively weight bearing (standard of care)
    Standard of care mobilization at 10 weeks post-operatively. Gait analyses is carried out on when full mobilization is allowed. Gait analysis is performed while using force-measuring insoles (loadsol, Novel).

Первичные конечные точки

  • Average peak load (Newtons (N)) [Срок оценки: 6 weeks for early mobilization group]
  • Average peak load (Newtons (N)) [Срок оценки: 10 weeks for standard of care (SOC) group]
  • Average peak load (Newtons (N)) [Срок оценки: 1 week after full weight bearing is allowed for both 6 week early mobilization and SOC groups.]
  • Average peak load (Newtons (N)) [Срок оценки: 2 weeks after full weight bearing is allowed for both 6 week early mobilization and SOC groups.]
  • Average peak load (Newtons (N)) [Срок оценки: 6 weeks after full weight bearing is allowed for both 6 week early mobilization and SOC groups.]
  • Average peak load (Newtons (N)) [Срок оценки: 12 weeks after full weight bearing is allowed for both 6 week early mobilization and SOC groups.]
  • Average peak load (Newtons (N)) [Срок оценки: 6 months after full weight bearing is allowed for both 6 week early mobilization and SOC groups.]

Критерии участия

Критерии включения

  • Adult patients, at least 18 years of age, max 65 years of age
  • Unilateral tibial plateau fracture AO:41b/c
  • Written consent to participate (consent can be revoked at any time without giving reasons)
  • Surgery during the study period
  • Follow-up on-site (Salt Lake City, Utah, United States)

Критерии исключения

  • Multiple injured or polytraumatized patients
  • Other injuries or illnesses that impair the patient's mobility or gait
  • Cognitive limitations such as dementia, delirium or similar disease
  • Refusal to participate
  • Severe underlying disease with significant limitations in the ability to regenerate e.g.

malignancies

  • Pathologic or osteoporotic fractures
  • Unable to attend clinic in person for follow-ups
  • pregnant women and fetus

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

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • University of Utah Orthopedics — Salt Lake City

Идентификаторы

NCT: NCT06389240 · 160848

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗