- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT05150925
Немедленная мобилизация по сравнению с 2-недельной иммобилизацией гипсовой повязкой после лечения перелома дистального отдела лучевой кости ладонной фиксирующей пластиной (LIMPER-DRF)
Немедленная мобилизация по сравнению с 2-недельной иммобилизацией гипсовой повязкой после лечения перелома дистального отдела лучевой кости ладонной фиксирующей пластиной — протокол исследования для проспективного рандомизированного контролируемого исследования
The aim of this study is to analyze total lenght of the sick leace and functional outcome (PRWE) at 2 months between 2 weeks casting and immediate mobilization following volar plating for a DRF.
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
This study is a prospective, randomized, controlled trial. The aim of this study will be to compare the early postoperative outcomes of the patients enrolled in the early mobilization with those patients in post-operative 2-week casting following volar plating for a DRF. Co-primary outcome in this study will be the total lenght of sick leave and Patient-Rated Wrist Evaluation (PRWE) 2 months after the operation.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Intra- or extra articular DRF (Colles, Smith, Volar barton)
- operative treatment justified
Exclusion Criteria:
- Refusal to participate in the study
- Open fracture with a severity greater than Gustilo grade 1
- Patient aged less than 18 or over 65
- Patient does not understand written or spoken guidance in local languages
- Pathological fracture
- Previous fracture in the same wrist or forearm in the last 10 years, that has led to impairment of function
- Ipsilateral fracture in upper extremity
- Associated fractures of the ulna (except fractures of the PSU)
- Polytrauma
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 |
|---|---|
|
Экспериментальный: Немедленная мобилизация после перелома дистального отдела лучевой кости, обработанного ладонной фиксирующей пластиной
|
Immediate mobilization postoperatively without casting Volar plating of distal radius fracture |
|
Активный компаратор: 2-недельная иммобилизация гипсовой повязкой после перелома дистального отдела лучевой кости с применением ладонной фиксирующей пластины
|
Volar plating of distal radius fracture Dorsal cast placed in OR |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Patient-rated wrist evaluation questionnaire
Временное ограничение: 2 months
|
The PRWE is a 15-item questionnaire designed to measure wrist pain and disability in daily activities. It ranges from 100 (worst) to 0 (best). It consists of 2 subscales. Pain subscale contains 5 items. Function subscale contains total 10 items which are further divided into 2 sections: specific activities (having 6 items) and usual activities. |
2 months
|
|
Total lenght of the sick leave
Временное ограничение: 12 months
|
Total number of days of work during the 1 year study period |
12 months
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Patient-rated wrist evaluation questionnaire
Временное ограничение: 4 weeks
|
The PRWE is a 15-item questionnaire designed to measure wrist pain and disability in daily activities. It ranges from 100 (worst) to 0 (best). It consists of 2 subscales. Pain subscale contains 5 items. Function subscale contains total 10 items which are further divided into 2 sections: specific activities (having 6 items) and usual activities. |
4 weeks
|
|
Patient-rated wrist evaluation questionnaire
Временное ограничение: 6 months
|
The PRWE is a 15-item questionnaire designed to measure wrist pain and disability in daily activities. It ranges from 100 (worst) to 0 (best). It consists of 2 subscales. Pain subscale contains 5 items. Function subscale contains total 10 items which are further divided into 2 sections: specific activities (having 6 items) and usual activities. |
6 months
|
|
Patient-rated wrist evaluation questionnaire
Временное ограничение: 12 months
|
The PRWE is a 15-item questionnaire designed to measure wrist pain and disability in daily activities. It ranges from 100 (worst) to 0 (best). It consists of 2 subscales. Pain subscale contains 5 items. Function subscale contains total 10 items which are further divided into 2 sections: specific activities (having 6 items) and usual activities. |
12 months
|
|
Return to work
Временное ограничение: 4 weeks
|
Patient is asked if he or she has returned to the previous work. If no patient is asked is he or she Still on sick leave, partial sick leave or returned to other work. |
4 weeks
|
|
Return to work
Временное ограничение: 2 months
|
Patient is asked if he or she has returned to the previous work. If no patient is asked is he or she Still on sick leave, partial sick leave or returned to other work. |
2 months
|
|
Return to work
Временное ограничение: 6 months
|
Patient is asked if he or she has returned to the previous work. If no patient is asked is he or she Still on sick leave, partial sick leave or returned to other work. |
6 months
|
|
Return to work
Временное ограничение: 12 months
|
Patient is asked if he or she has returned to the previous work. If no patient is asked is he or she Still on sick leave, partial sick leave or returned to other work. |
12 months
|
|
Complications
Временное ограничение: 4 weeks
|
Any surgery related complication: wound dehiscence, deep infection, flexor tendon rupture, nerve injury, mechanical complications, nonunion, malunion, complex regional pain syndrome |
4 weeks
|
|
Complications
Временное ограничение: 2 months
|
Any surgery related complication: wound dehiscence, deep infection, flexor tendon rupture, nerve injury, mechanical complications, nonunion, malunion, complex regional pain syndrome |
2 months
|
|
Complications
Временное ограничение: 6 months
|
Any surgery related complication: wound dehiscence, deep infection, flexor tendon rupture, nerve injury, mechanical complications, nonunion, malunion, complex regional pain syndrome |
6 months
|
|
Complications
Временное ограничение: 12 months
|
Any surgery related complication: wound dehiscence, deep infection, flexor tendon rupture, nerve injury, mechanical complications, nonunion, malunion, complex regional pain syndrome |
12 months
|
|
Self-perceived working ability
Временное ограничение: 4 weeks
|
Patient is asked to rate his os her working ability using two scales: NRS from 0 (fully disabled) to 10 (best capability) and ordinally (fully capable, partially capable, fully disabled). |
4 weeks
|
|
Self-perceived working ability
Временное ограничение: 2 months
|
Patient is asked to rate his os her working ability using two scales: NRS from 0 (fully disabled) to 10 (best capability) and ordinally (fully capable, partially capable, fully disabled). |
2 months
|
|
Self-perceived working ability
Временное ограничение: 6 months
|
Patient is asked to rate his os her working ability using two scales: NRS from 0 (fully disabled) to 10 (best capability) and ordinally (fully capable, partially capable, fully disabled). |
6 months
|
|
Self-perceived working ability
Временное ограничение: 12 months
|
Patient is asked to rate his os her working ability using two scales: NRS from 0 (fully disabled) to 10 (best capability) and ordinally (fully capable, partially capable, fully disabled). |
12 months
|
|
Visual analogue pain scale
Временное ограничение: 4 weeks
|
Overall pain during last 7 days in a scale from 0 to 100 (worst) |
4 weeks
|
|
Visual analogue pain scale
Временное ограничение: 2 months
|
Overall pain during last 7 days in a scale from 0 to 100 (worst) |
2 months
|
|
Visual analogue pain scale
Временное ограничение: 6 months
|
Overall pain during last 7 days in a scale from 0 to 100 (worst) |
6 months
|
|
Visual analogue pain scale
Временное ограничение: 12 months
|
Overall pain during last 7 days in a scale from 0 to 100 (worst) |
12 months
|
|
Patient-acceptable symptom state
Временное ограничение: 2 months
|
Patient satisfaction will be measured using the patient-acceptable symptom state (PASS).The questionnaires will include the following questions: Would you be willing to take the same treatment again if the treatment result was as it is now? (Yes/No) Considering all the different ways your injury is affecting you, if you would remain in this state, do you feel that your current state is satisfactory (Yes/No)? |
2 months
|
|
Patient-acceptable symptom state
Временное ограничение: 6 months
|
Patient satisfaction will be measured using the patient-acceptable symptom state (PASS).The questionnaires will include the following questions: Would you be willing to take the same treatment again if the treatment result was as it is now? (Yes/No) Considering all the different ways your injury is affecting you, if you would remain in this state, do you feel that your current state is satisfactory (Yes/No)? |
6 months
|
|
Patient-acceptable symptom state
Временное ограничение: 12 months
|
Patient satisfaction will be measured using the patient-acceptable symptom state (PASS).The questionnaires will include the following questions: Would you be willing to take the same treatment again if the treatment result was as it is now? (Yes/No) Considering all the different ways your injury is affecting you, if you would remain in this state, do you feel that your current state is satisfactory (Yes/No)? |
12 months
|
|
Work capacity
Временное ограничение: 4 weeks
|
The participants will be asked to rate their working capacity on a numerical scale from 0 to 10, with "0" being not able to work at all and "10" being the ability to work at its best. |
4 weeks
|
|
Work capacity
Временное ограничение: 2 months
|
The participants will be asked to rate their working capacity on a numerical scale from 0 to 10, with "0" being not able to work at all and "10" being the ability to work at its best. |
2 months
|
|
Work capacity
Временное ограничение: 6 months
|
The participants will be asked to rate their working capacity on a numerical scale from 0 to 10, with "0" being not able to work at all and "10" being the ability to work at its best. |
6 months
|
|
Work capacity
Временное ограничение: 12 months
|
The participants will be asked to rate their working capacity on a numerical scale from 0 to 10, with "0" being not able to work at all and "10" being the ability to work at its best. |
12 months
|
Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Patient activity
Временное ограничение: 4 weeks
|
Patient activity measured with triaxial wrist accelerometer |
4 weeks
|
Соавторы и исследователи
Спонсор
Следователи
- Директор по исследованиям: Aleksi Reito, Tampere University Hospital
- Главный следователь: Laura Kärnä, MD, Tampere University Hospital
Публикации и полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
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
- R21111
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
Data is available on reasonable request.
Сроки обмена IPD
After the study has been completed and for 10 years after.
Критерии совместного доступа к IPD
On reasonable request and research plan for IPD use should be provided.
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- САП
- МКФ
- АНАЛИТИЧЕСКИЙ_КОД
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.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .