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Идёт набор NCT05929755

Depo-Medrol on Psoas After LLIF

Фаза IV С лечением Muscle Weakness Pain, Postoperative Paresthesia Pain, Muscle

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: Depo-Medrol, Gel-Flow NT.
Кому может быть актуально
Состояния в реестре: Muscle Weakness, Pain, Postoperative, Paresthesia, Pain, Muscle. Базовые параметры: 18 лет — 75 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

Effect of Depo-Medrol Application on the Psoas Muscle After Transpsoas LLIF on Post-operative Hip Flexor Weakness, Thigh Pain and Numbness

Обзор

The goal of this study is to determine the effects of a corticosteroid administered to the psoas muscle following a transpsoas lateral lumbar interbody fusion (LLIF) on postoperative hip flexor weakness and thigh pain and numbness.

Подробное описание

Primary Objective and Outcome Measure:

* Quantify the difference in thigh pain measured on the visual analog pain scale (VAS) between those receiving a depo-medrol injection and those who did not over 3 postoperative time periods: 2-3, 6, and 12 weeks following surgery.

Secondary Objectives and Outcome Measures:

* Quantify the difference in rates and severity of postoperative hip flexor weakness, and numbness both with and with out application of depo-medrol to the psoas between those that did and did not receive a depo-medrol injection. * Quantity patient reported outcomes measures (PROMs) (EQ5D, ODI, and sciatica Bothersome index between those that did and did not receive a depo-medrol injection. Specifically:

* EQ5D: Eur-Quality of Life 5 dimension questionnaire * ODI: Oswestry Disability Index * Determine effect of depo-medrol application on fusion rates and how it differs between those that did and did not receive a depo-medrol injection.

Ancillary Objectives and Outcome Measures:

* To determine the effect of clinically relevant covariates including sociodemographic and comorbidities on the course of postoperative pain and associated outcome measures and whether the effect of these covariates moderate the effect of postoperative pain.

Groups:

* Control group (standard care) - 1cc gel foam powder mixed with thrombin * Steroid group (standard care + study intervention) - 1cc gel foam powder mixed with thrombin and 80mg depomedrol

Вмешательства

  • Препарат Depo-Medrol
    steroid
  • Препарат Gel-Flow NT
    hemostatic agent

Первичные конечные точки

  • Quantify the difference in thigh pain measured on the visual analog pain scale (VAS) between those receiving a depo-medrol injection and those who did not over 3 postoperative time periods: 2-3, 6, and 12 weeks following surgery. [Срок оценки: 2-3 weeks following surgery]
  • Quantify the difference in thigh pain measured on the visual analog pain scale (VAS) between those receiving a depo-medrol injection and those who did not over 3 postoperative time periods: 2-3, 6, and 12 weeks following surgery. [Срок оценки: 6 weeks following surgery]
  • Quantify the difference in thigh pain measured on the visual analog pain scale (VAS) between those receiving a depo-medrol injection and those who did not over 3 postoperative time periods: 2-3, 6, and 12 weeks following surgery. [Срок оценки: 12 weeks following surgery]
Вторичные конечные точки (6)
  • Quantify the difference in rates of postoperative thigh numbness both with and with out application of depo-medrol to the psoas between those that did and did not receive a depo-medrol injection. [Срок оценки: 6 months, 1 year, 2 years]
  • Quantify the difference in severity of postoperative hip flexor weakness both with and with out application of depo-medrol to the psoas between those that did and did not receive a depo-medrol injection. [Срок оценки: 6 months, 1 year, 2 years]
  • Quantity patient reported outcomes measures (PROMs) between those that did and did not receive a depo-medrol injection: Euro-Quality of Life 5 dimension questionnaire (EQ5D) [Срок оценки: 2-3 weeks, 6 weeks, 12 weeks, 6 months, 1 year, and 2 years]
  • Quantity patient reported outcomes measures (PROMs) between those that did and did not receive a depo-medrol injection: Oswestry Disability Index (ODI) [Срок оценки: 2-3 weeks, 6 weeks, 12 weeks, 6 months, 1 year, and 2 years]
  • Quantity patient reported outcomes measures (PROMs) between those that did and did not receive a depo-medrol injection: Sciatica Bothersomeness Index [Срок оценки: 2-3 weeks, 6 weeks, 12 weeks, 6 months, 1 year, and 2 years]
  • Determine effect of depo-medrol application on fusion rates and how it differs between those that did and did not receive a depo-medrol injection. [Срок оценки: 1 year and 2 years]

Критерии участия

Критерии включения

  • Patients from the practices of Drs. Singh, Mallozzi, Moss
  • Transpsoas (PTP or LTP) lateral lumbar interbody fusion (LLIF) 1-3 disc levels with posterior instrumentation (Open or MIS) with or without laminectomy, must include L3-4 and/or L4-5
  • Patients who agree to be a part of the study
  • Patients with lumbar disc degeneration
  • Patients between ages of 18 and 75

Критерии исключения

  • Scoliosis >10°
  • Spondylolisthesis >Grade 1
  • Flatback deformity
  • Patients with insulin dependent diabetes
  • Patients with >3 levels of fusion
  • Alternative interbodies
  • Chronic oral steroid users
  • Patients with allergy/intolerance to depo-medrol or other steroids
  • Patients requiring bilateral transpsoas approaches
  • Patients with ipsilateral symptomatic hip pathology
  • Revision fusion procedures
  • Cases involving trauma, tumor, or infection
  • Patient's not capable of providing consent themselves
  • Non-fluent English speakers (for consenting reasons)
  • Patients who are lost to follow-up before the two year follow up period

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
Простое слепое
Основная цель
Другое

Центры проведения

США · 1 центр
  • UConn Health — Farmington

Идентификаторы

NCT: NCT05929755 · 23-090-2

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗