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Набор скоро начнётся NCT07135687

Study to Use Oral Losartan to Decrease the Risk of Postoperative Scarring Following (ACL) Reconstruction

Фаза IV С лечением ACL Injury ACL Reconstruction Scar Formation

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: Losartan, Placebo.
Кому может быть актуально
Состояния в реестре: ACL Injury, ACL Reconstruction, Scar Formation. 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
США
Следующий шаг
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Официальное название

Oral Losartan to Decrease the Risk of Postoperative Arthrofibrosis Following Primary and Revision Anterior Cruciate Ligament Reconstruction

Обзор

The purpose of this study to investigate the effect of using losartan (a blood pressure lowering drug with anti-scarring properties) on preventing primary postoperative arthrofibrosis (formation of abnormal scar tissue) in the knees in participants undergoing anterior cruciate ligament (ACL) repair surgery of their knee.

Подробное описание

Losartan, an angiotensin-II receptor blocker (ARB), approved by the Food and Drug Administration (FDA) for the treatment of hypertension and diabetic nephropathy, has garnered recent interest in the field of orthopedic surgery as an anti-fibrotic (anti-scarring) agent. Losartan's primary mechanism of action as an anti-hypertensive involves acting as a receptor antagonist for angiotensin II, a peptide produced by the liver which causes vasoconstriction, release of anti-diuretic hormone from the pituitary gland, and release of aldosterone from the adrenal glands, among other functions. Losartan secondary function is to act as a TGF-β1 blocker. TGF-β1 has been implicated in pro-fibrotic pathways in multiple organs systems. Losartan, initially as a treatment for hypertension and diabetic nephropathy, was found to have benefits against fibrosis in the renal system. As a result, the use of losartan has gained interest in several other fields in medicine, including plastic surgery for wound healing and keloid prevention, in ophthalmology to prevent corneal scarring, and orthopedic surgery. The potential use of losartan presents an attractive anti-fibrotic prophylaxis candidate against the formation of postoperative arthrofibrosis following ACLR.

Вмешательства

  • Препарат Losartan
    Two types of losartan capsules will be compounded by combining a broken-up 25mg or 50mg losartan tablet and microcrystalline cellulose placebo filler to eliminate rattling of the broken tablet inside of the capsule. The 25mg losartan capsules will be yellow and the 50 mg losartan capsules will be blue.
  • Другое Placebo
    The placebo capsules will consist of microcrystal cellulose and will come in yellow and blue to appear identical to the losartan capsules.

Первичные конечные точки

  • Range of Motion [Срок оценки: 12 months]

Критерии участия

Критерии включения

  • Must be undergoing a primary ACLR with or without the following:
  • Chondroplasty
  • Synovectomy
  • Loose body removal
  • Removal of hardware
  • Meniscal surgery (excluding meniscal allograft transplantation/MAT)
  • Lateral extra-articular tenodesis
  • Must have skeletal maturity in the distal femur and proximal tibial physes
  • Must be age 18 years or older at time of enrollment

Критерии исключения

  • <18 years at time of enrollment
  • No diagnosis of ACL tear
  • ACL repairs
  • Revision ACL reconstructions
  • Open distal femur or proximal tibia physes
  • Major concomitant procedures (such as osteotomy, MAT, or cartilage restoration surgery)
  • History of prior proximal or distal femur fracture (including those receiving nonoperative treatment)
  • History of prior ipsilateral femur or tibia osteomyelitis
  • Medical history
  • History of hypotensive disease, including postural orthostatic hypotension syndrome (POTS), autonomic dysreflexia, or Shy-Drager syndrome (aka multiple system atrophy), baseline hypotension <90 systolic or <60 diastolic mmHg.
  • History of significant hepatic disease (liver transplantation, cirrhosis of any cause, or any liver disease with Child-Pugh classification B or C) due to hepatic metabolism of ARBs.
  • Chronic kidney disease
  • Rheumatologic disorders on immunologic medications
  • Current medications including diuretics (i.e. furosemide), lithium, and spironolactone
  • Current hypertension with prescription of an ARB or ACE-I
  • Allergy to losartan
  • Current pregnancy or breastfeeding

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Другое

Центры проведения

США · 1 центр
  • Rush University Medical Center — Chicago

Идентификаторы

NCT: NCT07135687 · 24120601

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗