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Набор скоро начнётся NCT07608237

The Purpose of This Pilot Study is to Determine Feasibility of a Randomized Controlled Trial Comparing Labral Repair Versus Reconstruction in Patients Over 40 Years of Age Undergoing Hip Arthroscopy for FAIS.

Без фазы С лечением Femoral Acetabular Impingement

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: Labral Repair, Labral Reconstruction.
Кому может быть актуально
Состояния в реестре: Femoral Acetabular Impingement. Базовые параметры: от 40 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
Канада
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Labral Repair Versus Reconstruction in Symptomatic Femoroacetabular Impingement in Patients Over 40 Years of Age - A Randomized Controlled Trial

Обзор

The purpose of this pilot study is to determine feasibility of a randomized controlled trial comparing labral repair versus reconstruction in patients over 40 years of age undergoing hip arthroscopy for FAIS. Specifically, we aim to: (1) estimate the proportion of eligible patients providing consent, (2) estimate the magnitude of the between-groups difference in the primary outcome (International Hip Outcome Tool \[iHOT\] - 33) to aid in sample size calculation for the full study, (3) estimate the compliance in completing the proposed outcome measures to determine the burden of questionnaire completion.

Подробное описание

Femoroacetabular impingement syndrome (FAIS) is an increasingly common cause hip pain1. It is known to cause labral pathology and if left untreated, can also contribute to the development of hip osteoarthritis2. While non-operative treatment has been shown to be effective and can improve patients' quality of life, surgical treatment has often been shown to yield superior outcomes, while also potentially decreasing the future risk of osteoarthritis3,4,5,6.

Mid- to long-term outcomes have shown durable results following hip arthroscopy with significant improvements in patient reported outcome measures (PROMs)7,8. Consequently, hip arthroscopy utilization has continued to increase. Several retrospective cohort studies have attempted to identify prognostic variables associated with procedural outcomes9-11. In terms of patient selection, age has historically been identified as a negative prognostic variable, with inferior clinical outcomes observed in patients over the age of 4012,13. However, more recent studies have disputed this finding, suggesting that earlier studies reporting this included patients with concomitant hip osteoarthritis, which was more to blame than their chronological age. Recent case series have reported significant improvements in PROMs in patients over the age of 40 who have minimal concomitant OA (Tönnis 0 or 1), with durable results out to 5 years14-16.

Despite these encouraging results, newer concerns have been raised when it comes to labral treatment in this demographic. It has been suggested that in patients over 40 years of age, the labrum may be too traumatized to allow repair or that it may have diminished healing capacity from repetitive impingement or age-related degeneration 17,18 . As such, there have been proponents of performing a primary labral reconstruction in this patient population, with better associated outcomes18. Others have reported equivocal outcomes between repair and reconstruction for this group19. As such, there is no consensus on the best treatment strategy to manage these patients.

The results of this pilot study will allow us to determine whether a full-scale study will be feasible. We will not move forward with the full study: 1) if the proportion of eligible patients providing consent is \<80%; 2) If the 95% confidence intervals around the difference between groups does not include even the possibility of a small, but important effect (0.2 SD); 3) if the proportion of patients completing their one-year follow-up is \<85%, then the study is not feasible.

Ultimately, for the full-scale study, we hypothesize that patients treated with labral reconstruction will have significantly better outcome scores compared with patients who underwent a traditional labral repair. If the hypothesized findings are true in the full study, this will change clinical practice patterns by providing objective evidence to guide treatment of labral pathology in patients over the age of 40 undergoing hip arthroscopy for FAIS.

Вмешательства

  • Процедура Labral Repair
    Standard arthroscopic osteochondroplasty and concomitant labral repair, using a minimum of two suture anchors.
  • Процедура Labral Reconstruction
    Standard arthroscopic osteochondroplasty and subsequent labral reconstruction with allograft.

Первичные конечные точки

  • International Hip Outcome Tool (iHOT) - 12 [Срок оценки: Baseline to 2 years post surgical follow-up]
Вторичные конечные точки (8)
  • Hip Outcome Score- Activities of Daily Living (HOS-ADL) [Срок оценки: Baseline to 2 years post surgical follow-up]
  • Hip Outcome Score- Sport Specific Subscale (HOS-SSS) [Срок оценки: Baseline to 2 years post surgical follow-up]
  • modified Harris Hip Score (mHHS) [Срок оценки: Baseline to 2 years post surgical follow-up]
  • EQ-5D [Срок оценки: Baseline to 2 years post surgical follow-up]
  • Cost Diary [Срок оценки: 6 weeks to 2 years post surgical follow-up]
  • Patient Satisfaction Scale [Срок оценки: 6 weeks to 2 years post surgical follow-up]
  • Post-operative complication rates [Срок оценки: 6 weeks to 2 years post surgical follow-up]
  • Subsequent surgery rates [Срок оценки: 6 weeks to 2 years post surgical follow-up]

Критерии участия

Inclusion:

-Cam or pincer morphology who have failed a trial of conservative treatment

Exclusion:

  • Moderate concomitant OA (Tönnis 2+)
  • Have had previous hip surgery
  • Active joint or systemic infection
  • Significant muscle paralysis
  • Inflammatory arthropathies
  • Significant medical comorbidity that may alter effectiveness of surgical intervention
  • Active smoker
  • Major medical illness
  • Unable to speak and understand English
  • Psychiatric illness that precludes informed consent
  • Unwilling to be followed for 2 years

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
Лечение

Центры проведения

Канада · 1 центр
  • Fowler Kennedy Sport Medicine Clinic — London

Идентификаторы

NCT: NCT07608237 · 127777

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗