Which Markers of Musculoskeletal Health Can Explain Complications in Spinal Surgery?
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: screening.
- Кому может быть актуально
- Состояния в реестре: Spine Injuries and Disorders. 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
- Италия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
ORTHOSPINE FITNESS: Which Markers of Musculoskeletal Health Can Explain Complications in Spinal Surgery?
Обзор
The present study is related to the project "ORTHOSPINE FITNESS: WHICH MARKERS OF MUSCULOSKELETAL HEALTH CAN EXPLAIN COMPLICATIONS IN SPINE SURGERY?", winner of the Ministry of Health Call, financed by the European Union, "M6/C2\_CALL 2023", Project Code " PNRR- MCNT2-2023-12378098", Call section "Non-chronic chronic diseases transmissible diseases (MCnT2) with a high impact on health systems". Complications of spinal surgery still represent a significant and unsolved problem. Their incidence is between 7 and 20%, with a high percentage of mechanical complications observed in patients operated on for degenerative pathologies. Readmissions, re-operations and subsequent rehabilitation treatments have a heavy impact on patients and the entire healthcare system.
Подробное описание
The study proposed, financed through the "PNRR-MCNT2-2023-12378098" call, is a multicenter study on a large cohort of patients undergoing spinal surgery for degenerative pathologies of the thoraco-lumbar spine, which has as its general objective to establish a comprehensive preoperative screening of bone health and the musculoskeletal system, combining advanced imaging and modeling (HRpQCT images of bone microstructure at peripheral sites and related computational assessment of bone mechanical properties), assessment of physical fragility (including muscle strength and assessment of proprioception/fall risk), cellular and molecular analyzes of bone fitness and bone-muscle cross-talk, and assessment of nutritional status.
The results of the project will allow us to: (i) define a concept of "surgical suitability" to evaluate patients candidates for elective spinal surgery and possibly improve the surgical decision-making process (for example the choice of fixation and instrumentation); (ii) identify a minimum set of significant and independent markers to monitor in future interventional studies aimed at reducing the risk of adverse events in spinal surgery, (iii) allow patient-specific preoperative interventions (such as nutritional supplementation, physical pre-habilitation or administration of bone anabolic agents)
Вмешательства
- Другое screening
Comprehensive screening of bone metabolic status and bone fragility in the largest cohort to date of patients with degenerative spinal diseases
Первичные конечные точки
- radiological images [Срок оценки: at baseline (day 0)]
- biological samples [Срок оценки: at baseline (day 0), after 6 months, after 12 months]
- pain [Срок оценки: at baseline (day 0), after 12 months]
- Quality of life [Срок оценки: at baseline (day 0), after 6 months, after 12 months]
- nutritional informations [Срок оценки: since day 1 to day 14]
Критерии участия
Критерии включения
- Age >= 18 years;
- diagnosis of degenerative pathology of the spinal column of the thoraco-lumbo-sacral tract;
- patients candidates for surgical treatment for the aforementioned pathology during the study period;
- willingness to participate in the study and sign the specific informed consent
Критерии исключения
- presence of tumors or infections in the spinal column;
- presence of degenerative pathology of the spine without surgical indication;
- presence of degenerative pathology of the spinal column at the cervical level.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Диагностика
Центры проведения
Италия · 2 центра
- Istituto Ortopedico Rizzoli — Bologna
- Azienda ospedaliera universitaria Luigi Vanvitelli — Naples
Идентификаторы
NCT: NCT06736106 · OrthoSpine Fitness · PNRR-MCNT2-2023-12378098