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Идёт набор NCT06883396

JUPITER 4.0 - Risk Factors for Failure of Isolated Medial Patellofemoral Ligament Reconstruction

— Наблюдательное Patellar Dislocation, Recurrent Patellar Dislocation Patellar Instability Patellofemoral Dislocation

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: Medial Patellofemoral Ligament (MPFL) Reconstruction.
Кому может быть актуально
Состояния в реестре: Patellar Dislocation, Recurrent, Patellar Dislocation, Patellar Instability, Patellofemoral Dislocation. Базовые параметры: 10 лет — 35 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The goal of this observational study is to learn about the outcomes of medial patellofemoral ligament (MPFL) reconstruction for the treatment of recurrent patellar instability. The main questions it aims to answer are: * What are the risk factors for recurrent patellar instability after MPFL reconstruction? * What functional outcomes do patients report after MPFL reconstruction? Participants undergoing MPFL reconstruction will answer survey questions about their knee and activity level 1 year and 2 years after surgery.

Подробное описание

The JUPITER group consists of high-volume patellofemoral surgeons across the United States, and was organized to facilitate the collection of clinical and radiographic outcomes following surgical and non-surgical treatment of patellar instability. With this study (JUPITER 4.0), the group aims to prospectively enroll a new cohort of consecutive patients with recurrent patellar instability that would undergo isolated MPFL reconstruction regardless of radiographic measurements or anatomic risk factors to address two specific aims - 1) what patient, injury, and surgical factors lead to recurrent instability following isolated MPFL reconstruction and 2) the creation of an instability severity index score, with the long-term objective of identifying preoperatively, patients with a high risk of failure of an isolated MPFL reconstruction who may be better served with concomitant bony procedure.

Вмешательства

  • Процедура Medial Patellofemoral Ligament (MPFL) Reconstruction
    For the purposes of this study, isolated MPFL reconstruction is defined as MPFL reconstruction with a tendon graft, with or without additional soft tissue procedure(s) including lateral retinacular lengthening or release, patellofemoral chondroplasty and/or cartilage restoration. No patient in the study will receive a bony realignment procedure to treat patellar instability.

Первичные конечные точки

  • Recurrent patellar instability [Срок оценки: Within 24 months post-operatively]
Вторичные конечные точки (6)
  • Patient-Reported Outcome Measures (PROMs): Kujala score [Срок оценки: 12 months post-operatively and 24 months post-operatively]
  • Patient-Reported Outcome Measures (PROMs): Pedi-IKDC [Срок оценки: 12 months post-operatively and 24 months post-operatively]
  • Patient-Reported Outcome Measures (PROMs): HSS Pedi-FABS [Срок оценки: 12 months post-operatively and 24 months post-operatively]
  • Patient-Reported Outcome Measures (PROMs): KOOS-12 [Срок оценки: Time Frame: 12 months post-operatively and 24 months post-operatively]
  • Patient-Reported Outcome Measures (PROMs): BPII 2.0 [Срок оценки: 12 months post-operatively and 24 months post-operatively]
  • Patient-Reported Outcome Measures (PROMs): PROMIS-29 [Срок оценки: 12 months post-operatively and 24 months post-operatively]

Критерии участия

Критерии включения

  • 10-35 years old
  • Recurrent patellar instability with at least one episode defined as either (1) a dislocated patella requiring reduction in the emergency department or (2) a convincing history for dislocation, associated with full giving way, and the following physical findings: (a) hemarthrosis or effusion, (b) tenderness along the medial retinaculum, and (c) apprehension when laterally directed force was applied to the patella or (3) MRI-documented dislocation with associated bone bruises

Критерии исключения

  • Previous ipsilateral knee surgery
  • Obligatory/fixed/habitual patella dislocation or subluxation
  • Unloadable inferior or lateral chondral damage on the patella that would require a tibial tubercle transfer for unloading purposes
  • Pathologic tibiofemoral instability

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 · 16 центров
  • Stanford University — Redwood City
  • University of Florida — Gainesville
  • Midwest Orthopaedics at Rush — Chicago
  • University of Iowa — Iowa City
  • Massachusetts General Hospital — Boston
  • Boston Children's Hospital — Boston
  • Mayo Clinic — Rochester
  • Mount Sinai — New York
  • … и ещё 8 центров

Идентификаторы

NCT: NCT06883396 · 2022-0649

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗