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Идёт набор NCT05484089

CapFlex PIP Implant RSA

— Наблюдательное Osteoarthritis Hand

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: CapFlex PIP implant.
Кому может быть актуально
Состояния в реестре: Osteoarthritis Hand. 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
Нидерланды
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Migration of the CapFlex-PIP Implant System for Proximal Interphalangeal Joint Arthroplasty: a 10 Year Follow up RSA Study

Обзор

Rationale: Patients with osteoarthrtis (OA) of the proximal interphalangeal (PIP) joint are commonly treated with joint arthroplasty. The CapFlex PIP implant is a modular surface replacing implant, which has good short-term functional results with a relatively low complication rate. To reduce implant failure and to increase long-term survival, it is important to expand knowledge about fixation and loosening patterns. By using model-based roentgen stereogrammaetric analysis (mRSA), the migration pattern of the implant over time can be calculated. Objective: The primary objective is to assess the fixation and migration patterns of the CapFlex PIP implant system (produced and developed by several companies of KLS Martin Group) in vivo, using mRSA, over 10 years. Secondary objectives are to analyse survival, clinical scores and radiographic aspects of the CapFlex PIP implant system. Study design: A prospective cohort study with 10 years follow-up, in which 36 patients will be enrolled. Patients will be evaluated preoperatively, at 6 weeks, 6 months, 1 year, 2 years 5 years and 10 years. Study population: Patients 18 years or older who require a proximal interphalangeal joint arthroplasty as a result of osteoarthritis of a proximal interphalangeal joint. Main study parameters/endpoints: The main study parameters are the migration of the CapFlex PIP implant system of the distal as well as the proximal component (presented in x-, y- and z-direction). Secondary study parameters are the survival of the CapFlex PIP implant system, clinical scores and radiographic aspects. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients participating in the study will have the same risks when not participating in the study. Patients are asked to spend time to fill in the questionnaires and to have 3 extra visits to the hospital, next to the standard visits. Patients will have more follow up visits and will be followed using RSA analysis, which has as advantage that possible complications might be noticed earlier compared to normal follow up.

Вмешательства

  • Устройство CapFlex PIP implant
    Patients receive the CapFlex PIP implant based on regular care. During surgery tantalum markers are placed in the bone surrounding the implant.

Первичные конечные точки

  • The change in Translation in mm [Срок оценки: postoperative baseline, 6 weeks, 6 months, 1 year, 2 years, 5 years and 10 years.]
Вторичные конечные точки (7)
  • Rotation in degrees [Срок оценки: postoperative baseline, 6 weeks, 6 months, 1 year, 2 years, 5 years and 10 years.]
  • Survival [Срок оценки: postoperative at 6 weeks, 6 months, 1 year, 2 years, 5 years and 10 years.]
  • Radiographic aspects [Срок оценки: postoperative baseline and at 6 weeks, 6 months, 1 year, 2 years, 5 years and 10 years.]
  • Michigan Hand Outcomes Questionnaire (MHOQ) [Срок оценки: postoperative baseline and at 6 weeks, 6 months, 1 year, 2 years, 5 years and 10 years.]
  • Patient Rated Wrist / Hand Evaluation (PRWHE) [Срок оценки: postoperative baseline and at 6 weeks, 6 months, 1 year, 2 years, 5 years and 10 years.]
  • EuroQol-5D (EQ-5D-5L) [Срок оценки: postoperative baseline and at 6 weeks, 6 months, 1 year, 2 years, 5 years and 10 years.]
  • Numeric Rating Scale (NRS) [Срок оценки: postoperative baseline and at 6 weeks, 6 months, 1 year, 2 years, 5 years and 10 years.]

Критерии участия

Критерии включения

  • Indication for PIP joint arthroplasty as described in the manufacturer's guideline, namely as a result of:
  • Painful osteoarthritis
  • Instable communitive intra-articular PIP fractures
  • Age > 18 years
  • Patient is able to speak and write Dutch
  • Patient is willing to participate
  • Patient is able and willing to provide written informed consent

Критерии исключения

  • Inflammatory arthritis with significant bone loss
  • Insufficient bone quality to provide adequate stability
  • Known or suspected sensitivity or allergy to one or more of the implant materials
  • Revision surgery
  • Significant collateral instability
  • Pregnancy or breastfeeding

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Нидерланды · 1 центр
  • Reinier Haga Orthopedisch Centrum — Zoetermeer

Идентификаторы

NCT: NCT05484089 · OC-2021-019

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗