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Набор по приглашению NCT02040714

Multicenter Prospective Cohort Study on Current Treatments of Legg-Calvé-Perthes Disease

Наблюдательное Legg Calve Perthes Disease

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: Osteotomy + Long Term Non-Weight Bearing, Osteotomy + Short Term Non-Weight Bearing, Nonoperative Observation, Multiple Epiphyseal Drilling.
Кому может быть актуально
Состояния в реестре: Legg Calve Perthes Disease. Базовые параметры: 1 год — 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
США, Австралия, Бразилия, Канада, Китай +10
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

Legg-Calvé-Perthes disease is a childhood hip disorder which is common enough to be a significant public health problem (affects 1 in 740 boys between ages 0-14), but uncommon enough to have a sufficient number of patients from a single institution to perform a definitive prospective study comparing the results of current treatments. The present study will establish a database of prospectively identified patients with Legg-Calvé-Perthes (LCP) Disease and collect information regarding their presentation, treatment, and outcomes in the course of receiving currently available treatments. This study seeks to compare the outcomes of current treatments in the management of different age groups (ages 1-6, 6-8, 8-11, \>11) of patients with Perthes disease at two- and five-year followup and at skeletal maturity. For each age group, two to three common treatment regimens currently used by practicing pediatric orthopaedic surgeons will be compared. The intervention a patient receives is determined through physician treatment expertise, and is not pre-determined by the study.

Подробное описание

Approximately 50 pediatric orthopaedic surgeons from pediatric centers in the US and other countries have agreed to participate in this database as members of the International Perthes Study Group (IPSG). TSRH will be the lead center. Sites who agree to participate will seek IRB approval from their own institutions. Data will be collected prospectively and entered into REDCap (Research Electronic Data Capture), a browser-based research database.

1-6 Cohort: For the 1-6 age patient group, patients involved in any treatment will be asked to participate in the study.

6-8 Cohort: For the 6-8 age patient group, patients presenting in an early stage of the disease (stage I or IIa), the surgeons who treat their patients with one of the following three treatment regimens currently used in practice will be asked to participate in the study :

1. Non-operative management (i.e., no osteotomy but can include soft tissue release); 2. Operative containment treatment (femoral or pelvic osteotomy or Shelf acetabuloplasty).

8-11 Cohort: For the 8-11 patient age group, patients presenting in an early stage of the disease (stage I or IIa), the surgeons who treat their patients with one of the following treatment regiments currently used in practice will be asked to participate in the study:

1. Non-operative management (i.e., no osteotomy); 2. Operative containment treatment (femoral or pelvic osteotomy or Shelf acetabuloplasty) followed by 6 weeks of postoperative non-weight bearing; and, 3. Operative containment treatment (femoral or pelvic osteotomy or Shelf acetabuloplasty) followed by 6 months of postoperative non-weight bearing.

\>11 Cohort Registry: For the \>11 patient age group, we will collect prospective data from surgeons who are currently treating their patients with any treatment regimens.

Patients who present to an IPSG member or their group during the late stages of the disease (stage IIb or stage III) will also be arranged into four separate age cohorts, identical to the list above. We will collect prospective data for these cases, as well.

Regardless of the patient's stage at enrollment, the patient's age at diagnosis or assigned cohort, the following data will be collected: information regarding patient characteristics at presentation, physical exam findings, responses to Perthes patient and/or outcomes questionnaires, and results of radiographic and MR imaging.

Participants will be assigned a unique study number. A secure web application, REDCap, will be used to capture and store research information including radiographic and MR images, clinical information, and de-identified outcomes questionnaire responses. Data will be transmitted and stored on a secure and dedicated server for the purpose of this study.

Вмешательства

  • Процедура Osteotomy + Long Term Non-Weight Bearing
    Surgical procedure that improves femoral head containment, plus a post-operative protocol that requires patient to maintain non-weight bearing for 6 months.
  • Процедура Osteotomy + Short Term Non-Weight Bearing
    Surgical procedure that improves femoral head containment, plus a post-operative protocol that allows early return to function after 6 weeks of non-weight bearing.
  • Процедура Nonoperative Observation
    Group will not undergo any surgical or invasive procedures during course of treatment.
  • Процедура Multiple Epiphyseal Drilling
    Multiple epiphyseal drilling is a procedure that creates small holes in the femoral head growth plate to increase blood flow into the femoral head.

Первичные конечные точки

  • Sphericity deviation score of the femoral head [Срок оценки: 5 years post intervention]
Вторичные конечные точки (1)
  • Perfusion percentage [Срок оценки: Just after diagnosis of Perthes disease]

Критерии участия

Критерии включения

  • Diagnosed with Legg-Calvé-Perthes disease
  • Between age 1-18
  • Patients with possible secondary femoral osteonecrosis if over the age of 11 due to trauma or corticosteroid therapy are also eligible.

Критерии исключения

  • Patients with previous surgical treatment on the affected hip

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 28 центров
  • Children's Hospital of Alabama — Birmingham
  • Children's Hospital of Los Angeles — Los Angeles
  • Kaiser Permanente Hospital — Los Angeles
  • Rady Children's Hospital California — San Diego
  • UCSF Benioff Children's Hospitals — San Francisco
  • Children's Hospital Colorado — Aurora
  • Connecticut Children's Medical Center — Hartford
  • Alfred I. DuPont Hospital for Children of the Nemours Foundation — Wilmington
  • … и ещё 20 центров
Германия · 3 центра
  • Children's Hospital Hamburg-Altona — Hamburg
  • Hospital of Schleswig-Holstein — Lübeck
  • University Hospital of Schleswig-Holstein (Campus Lubeck) — Lübeck
Канада · 2 центра
  • Alberta Children's Hospital, Division of Paediatric Surgery — Calgary
  • British Columbia Children's Hospital — Vancouver
Великобритания · 2 центра
  • Alder Hey Children's Hosopital (University of Oxford) — Liverpool
  • Southampton Children's Hospital — Southampton
Австралия · 1 центр
  • Women and Children's Hospital of Adelaide — Adelaide
Бразилия · 1 центр
  • Universidade de São Paulo — São Paulo
Китай · 1 центр
  • Tianjin Hospital Pediatric Orthopedics — Тяньцзинь
Индия · 1 центр
  • Kasturba Medical College (KMC), Manipal — Udupi
Ирландия · 1 центр
  • Children's Health Ireland at Temple Street — Dublin
Норвегия · 1 центр
  • Oslo University Hospital — Oslo
Польша · 1 центр
  • Medical University of Lodz — Lodz
Пуэрто-Рико · 1 центр
  • San Jorge Children's Hospital — San Juan
Испания · 1 центр
  • Hospital Infantil Universitario Nino Jesus — Madrid
Швеция · 1 центр
  • Uppsala University — Uppsala
Швейцария · 1 центр
  • Centre hopsitalier universitaire Vaudois — Lausanne

Идентификаторы

NCT: NCT02040714 · IPSG 001

Первоисточники (государственные реестры)

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