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Идёт набор NCT05314608

Knee Related Subchondral Bone Lesions Treated With IOBP

— Наблюдательное Subchondral Cyst

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: IntraOsseous BioPlasty® (IOBP®) Surgical Technique into the knee.
Кому может быть актуально
Состояния в реестре: Subchondral Cyst. Базовые параметры: 18 лет — 60 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
Следующий шаг
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Официальное название

Prospective Study of Bone Pathologies Resulting From Acute or Chronic Injury Treated With IntraOsseous BioPlasty® (IOBP®) Surgical Technique

Обзор

The study will be a prospective, multicenter clinical study evaluating clinical and patient reported outcome measures of subjects receiving IOBP® surgical technique using Angel cPRP and BMA processing system to treat subchondral bone pathology (SBP).

Подробное описание

The study will be a prospective, multicenter, clinical study, enrolling both male and female patients. Subjects will be identified among the investigators' patient population scheduled for the IOBP® procedure and as being diagnosed with symptomatic SBP that have failed conservative management. IRB approval will be obtained by each participating institution.

The primary outcome measure is adverse event evaluation to determine whether IOBP® can prevent further surgical intervention (i.e., knee replacement surgery, HTO, or calcium phosphate stabilization of SBP) when used to treat symptomatic SBP of the knee.

Вмешательства

  • Комбинированный продукт IntraOsseous BioPlasty® (IOBP®) Surgical Technique into the knee
    Injection of a biologic mixture (BMC and allograft) into the subchondral bone lesion

Первичные конечные точки

  • Prevention of additional surgery into the target knee [Срок оценки: 5 years]
Вторичные конечные точки (5)
  • Visual Analog Pain Scale (VAS) [Срок оценки: Collected at pre-op, 1 week post-op, 6 weeks post-op, 3 months post-op, 6 months post-op , 1 years post-op , 2 years post-op, 3 years post-op , 4 years post-op and 5 years post-op.]
  • International Knee Documentation Committee Subjective Knee Evaluation Form [Срок оценки: knee-specific instrument, developed to assess the patients' opinion about their knee and associated problems. The KOOS evaluates both short-term and long-term consequences of knee injury.]
  • Knee Injury and Osteoarthritis Outcome Score (KOOS) [Срок оценки: Collected at pre-op, 1 week post-op, 6 weeks post-op, 3 months post-op, 6 months post-op , 1 years post-op , 2 years post-op, 3 years post-op , 4 years post-op and 5 years post-op]
  • X-rays of the knee [Срок оценки: 6 months and 1 year]
  • MRI of the knee [Срок оценки: 6 months and 1 year]

Критерии участия

Критерии включения

  • Able to read, understand, sign and complete informed consent
  • Male or female subject between the ages of 18-60 years
  • Subject has had pain for greater than three months
  • Subjects with single SBP in tibia or femur confirmed by minimum 1.5T MRI (including coronal, axial, sagittal, lateral femur, and lateral tibia views) and are candidates for an IOBP® procedure
  • Subject has stable ligaments
  • Subject has neutral alignment (max 5° varus or valgus)
  • Subject has a VAS score greater than or equal to five
  • Subject is scheduled to undergo surgical intervention using IOBP®

Критерии исключения

  • Subject has diabetes Type I, Type II uncontrolled, or Type II insulin dependent
  • Subject has had lower extremity surgery within six months
  • Subject has had more than two prior surgical procedures in the operative leg
  • Subject has a neuromuscular condition
  • Subject has a current infection
  • Subject has a BMI >35
  • Subject has subchondral bone collapse or Kellgren Lawrence grade IV osteoarthritis
  • Subject has joint surface collapse in late stage avascular necrosis
  • Subject has majority of pain associated with alternate conditions
  • Subject has had subchondral bone pathology caused by acute trauma
  • Subject is not neurologically intact.
  • Subject has history of invasive malignancy (except non-melanoma skin cancer)
  • Subject that has a planned or scheduled additional surgery within the course of the study (lower extremity)
  • Subject has an active substance abuse problem
  • Subject is currently taking narcotic pain medication
  • Subject is pregnant or planning to become pregnant
  • Subject is on worker's compensation
  • Subject has a concomitant procedure not including meniscectomy, synovectomy, chondroplasty, or removal of loose body
  • Inability to complete study requirements and follow-up visits
  • Subject that has a bone marrow aspiration that does not meet 60cc

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 · 5 центров
  • University of Colorado Sports Medicine — Denver
  • Andrews Research and Education Foundation — Gulf Breeze
  • TidalHealth Peninsula Regional, Inc. — Salisbury
  • The Ohio State University — Columbus
  • Allegheny-Singer Research Institute — Pittsburgh

Идентификаторы

NCT: NCT05314608 · 20085

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗