Clinical Evaluation of the Access Socket Flexible Socket for Transtibial Prosthesis (AS-TT)
Transtibial amputation significantly impacts patient autonomy and quality of life, primarily due to the limitations of conventional rigid sockets, which restrict comfort and joint range of motion. The Access Socket (AS) is an innovative prosthetic socket combining a rigid carbon-fiber structure in key load-bearing areas with flexible urethane-resin (ProtheFLEX®) zones in regions typically rigid in conventional sockets. This hybrid design aims to improve comfort and pressure distribution while preserving the mechanical properties required for ambulation.
The AS has already demonstrated benefits in transfemoral amputees and is now reimbursed in France for that population. A preliminary uncontrolled study in 12 transtibial amputees suggested significant improvements in perceived function, comfort, satisfaction, and mobility.
This multicenter, randomized, open-label, two-arm crossover study aims to compare the (AS) with the standard rigid socket (RS) in 25 adults with transtibial amputation. Participants will wear each socket for approximately 4 weeks (after a 1-2 week adaptation period) in a randomized order. The primary outcome is the Patient Specific Functional Scale (PSFS). Secondary outcomes include comfort (SCS), satisfaction (OPUS), psychosocial adjustment (TAPES-R), mobility (PLUS-M), prosthesis utility (PEQ-U), and the proportion of patients electing to keep the AS at study completion.
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
Background. Lower-limb amputation affects more than 7,500 people annually in France, with approximately 50% at the transtibial level. The socket is the critical interface between the residual limb and the prosthesis, transmitting mechanical forces while needing to remain comfortable. Currently, only RS (carbon or resin) are listed on the French reimbursable products list (LPPR) for transtibial amputation. Documented limitations of rigid sockets include restricted knee flexion, walking discomfort in challenging environments, donning difficulties, and suboptimal pressure distribution that does not adapt to residual-limb volume changes.
Investigational device. The AS follows the same molding and shaping principles as the standard RS but differs in two manufacturing steps: (1) carbon fibers are placed only on lateral, postero-inferior, and inferior areas to provide structural rigidity; (2) stratification uses urethane resin (ProtheFLEX®, already used in medical-device manufacturing) instead of epoxy or acrylic resin, creating soft zones in regions typically rigid in conventional sockets.
Comparator. Both sockets are manufactured from the same plaster mold to ensure strictly identical internal geometry. Only the material structure (carbon/urethane distribution) differs; all other prosthetic components (intermediate piece, prosthetic foot) are identical.
Design rationale. A double-blind design is not feasible because participants can perceive differences in socket rigidity and prosthesis weight. The crossover design controls for between-subject variability and order effects.
Sample size. Based on the preliminary study (Patient Specific Functional Scale (PSFS) standard deviation 1.74), to detect a difference of 1.3 points (the PSFS MDC₉₀ for 3 items) with 80% power and α=0.05, 19 participants are required. 25 will be enrolled to account for dropouts and to provide a more representative sample for secondary endpoints.
Visits. Four study visits over approximately 14-21 weeks per participant: inclusion (V0), evaluation after first socket period (V1), evaluation after second socket period (V2), and an optional follow-up visit (V3) one month later if the participant elects to keep the AS.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Isabelle Loiret, MD
- Номер телефона: +33383529950
- Электронная почта: isabelle.loiretpro@gmail.com
Учебное резервное копирование контактов
- Имя: Jonathan Pierret, PhD
- Электронная почта: jonathan.pierret@ugecam.assurance-maladie.fr
Места учебы
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Clamart, Франция, 92140
- Рекрутинг
- Hôpital National d'Instruction des Armées (HNIA) Percy
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Главный следователь:
- Marie Thomas-Pohl, MD
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Контакт:
- Marie Thomas-Pohl, MD
- Номер телефона: +33 1.41.46.62.82
- Электронная почта: marie.thomas@intradef.gouv.fr
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Freyming-Merlebach, Франция, 57804
- Рекрутинг
- Hôpital Filieris de Freyming-Merlebach
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Контакт:
- Catherine Achour, MD
- Номер телефона: +33 3 83 52 98 61
- Электронная почта: catherine.achour@filieris.fr
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Главный следователь:
- Catherine Achour
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Grenoble, Франция, 38434
- Рекрутинг
- CHU Grenoble Alpes - Hôpital Sud
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Контакт:
- Solène Maret, MD
- Номер телефона: +33 4 76 76 60 25
- Электронная почта: smaret2@chu-grenoble.fr
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Главный следователь:
- Solène MAret, MD
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Младший исследователь:
- Phillipe Escobar, MD
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Nancy, Франция, 54000
- Рекрутинг
- Institut Régional de Médecine Physique et de Réadaptation (IRR) - Filière Locomoteur
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Главный следователь:
- Isabelle Loiret, MD
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Контакт:
- Jonathan Pierret, PhD
- Электронная почта: jonathan.pierret@ugecam.assurance-maladie.fr
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Контакт:
- Christelle REQUENA
- Номер телефона: +33 3 83 52 98 61
- Электронная почта: christelle.requena@ugecam.assurance-maladie.fr
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Paris, Франция, 75007
- Рекрутинг
- Insititution Nationale des Invalides
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Контакт:
- Joseph Bascou, PhD
- Номер телефона: +33 3 87 51 30 30
- Электронная почта: joseph.bascou@invalides.fr
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Unilateral or bilateral transtibial amputation
- Currently fitted with a definitive carbon rigid socket
- Any residual-limb shape
- Any etiology
- Able to understand simple instructions, read, write, and provide informed consent - or able to be accompanied by a trusted person in case of inability to read/write autonomously
- Provided free written informed consent
- Aged 18 years or older
- Affiliated to a social security system
Exclusion Criteria:
- Use of hydroalcoholic solution (HAS) for socket donning
- Currently fitted with a provisional socket
- Neurological pathology limiting capacity to participate in activities
- Orthopedic pathology limiting capacity to participate in activities
- Pregnant or breastfeeding women
- Minors
- Persons not under legal protection or unable to express consent
- Persons under guardianship or curatorship
- Persons under judicial protection
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Назначение кроссовера
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Активный компаратор: Group 1 (RS -> AS)
Participants wear their standard rigid socket (RS) for 4 weeks, complete evaluation, then switch to the Access Socket (AS) for 1-2 weeks of adaptation followed by 4 weeks of wear, with a second evaluation.
|
Hybrid prosthetic socket combining a rigid carbon-fiber structure in load-bearing areas (lateral, postero-inferior, inferior) with flexible urethane-resin (ProtheFLEX®) zones in regions typically rigid in conventional sockets.
Manufactured from the same plaster mold as the rigid socket to ensure identical internal geometry.
Conventional definitive carbon-fiber rigid socket, currently the only socket type reimbursed in France for transtibial amputation (LPPR-listed).
Standard of care comparator.
|
|
Активный компаратор: Group 2 (AS -> RS)
Participants receive the Access Socket (AS) first, with 1-2 weeks of adaptation followed by 4 weeks of wear and evaluation.
They then switch to the standard rigid socket (RS) for 1-2 weeks of adaptation and 4 weeks of wear, with a second evaluation.
|
Hybrid prosthetic socket combining a rigid carbon-fiber structure in load-bearing areas (lateral, postero-inferior, inferior) with flexible urethane-resin (ProtheFLEX®) zones in regions typically rigid in conventional sockets.
Manufactured from the same plaster mold as the rigid socket to ensure identical internal geometry.
Conventional definitive carbon-fiber rigid socket, currently the only socket type reimbursed in France for transtibial amputation (LPPR-listed).
Standard of care comparator.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Patient Specific Functional Scale (PSFS) score
Временное ограничение: One time at the end of each 4-week wear period (V1, V2 and V3)
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Patient-centered self-report tool.
The patient identifies 3-5 specific activities they have difficulty performing, then rates their ability on a 0-10 scale (0 = unable to perform, 10 = able to perform at pre-injury level).
The final score is the mean of the ratings
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One time at the end of each 4-week wear period (V1, V2 and V3)
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Socket Comfort Scale (SCS) score
Временное ограничение: One time at the end of each 4-week wear period (V1, V2 and V3)
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0-10 numerical rating of socket comfort (0 = least comfortable imaginable, 10 = most comfortable imaginable)
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One time at the end of each 4-week wear period (V1, V2 and V3)
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Orthotics Prosthetics Users Survey (OPUS) score
Временное ограничение: One time at the end of each 4-week wear period (V1, V2 and V3)
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Self-report instrument evaluating functional outcomes and quality of life specifically for orthosis and prosthesis users.
Assesses lower-limb functional status, health-related quality of life, satisfaction with the device, and satisfaction with services.
The higher the score, the more favorable the result for the device
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One time at the end of each 4-week wear period (V1, V2 and V3)
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Trinity Amputation and Prosthesis Experience Scale - Revised (TAPES-R) score
Временное ограничение: One time at the end of each 4-week wear period (V1, V2 and V3)
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33-item multidimensional questionnaire evaluating psychosocial adjustment to amputation and prosthesis use, including general adjustment, social adjustment, activity restriction, and prosthesis satisfaction.
The higher the global score, the more favorable the result for the device
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One time at the end of each 4-week wear period (V1, V2 and V3)
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Prosthesis Evaluation Questionnaire - Utility subscale (PEQ-U) score
Временное ограничение: One time at the end of each 4-week wear period (V1, V2 and V3)
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The score is calculated as the mean of the 8 items in the subscale.
Each item is rated on a Visual Analogue Scale (VAS) from 0 to 100.
The total score ranges from 0 to 100, where higher scores indicate a better outcome (greater satisfaction and prosthesis utility)
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One time at the end of each 4-week wear period (V1, V2 and V3)
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Proportion of participants electing to keep the Access Socket at study completion
Временное ограничение: Through study completion, an average of 10 weeks
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Percentage of participants who choose the AS over the RS at the end of the study, reported with 95% confidence interval.
Participants are not informed of this option until the end of the study to avoid judgment bias
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Through study completion, an average of 10 weeks
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Соавторы и исследователи
Соавторы
Следователи
- Главный следователь: Isabelle Loiret, MD, Institut Régional de Médecine Physique et de Réadaptation (IRR), Nancy, France
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
- 2026-A00019-42
Планирование данных отдельных участников (IPD)
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Описание плана IPD
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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