Early Internal Fixation Versus NonOperative Care With Early Rehabilitation for LC1 Fragility Fractures of the Pelvis

Официальное название

Multicenter Randomized Controlled Trial Comparing Early Internal Fixation Versus NonOperative Care With Early Rehabilitation for LC1 Fragility Fractures of the Pelvis: A Pilot Study

Обзор

The goal of this randomized pilot study is to assess feasibility of the trial and to collect information to inform the design of a definitive trial. Adult patients ages 60 years or older with a low-energy lateral compression type 1 (LC1) pelvis fracture with \<10 mm initial displacement of the posterior pelvic ring will be eligible to participate in the study. Patients will be randomized to one of two treatment groups, early internal fixation or nonoperative care with early rehabilitation, defined as at least five days of attempted mobilization by rehabilitation providers. Participants will be followed for 1 year.

Подробное описание

More than half of fragility fractures of the pelvis in older adults exhibit a lateral compression type 1 fracture pattern (LC1), with fractures of the posterior pelvic ring involving the sacrum bone and a corresponding disruption of the anterior pelvic ring. Nonoperative treatment has remained the standard of care for older adults with minimally displaced (\<10 mm) LC1 fragility fractures of the pelvis, as patients are often able to mobilize within a few days with a walking aid. However, preliminary data have suggested that early internal fixation may lead to better patient outcomes, including improved ambulation, shorter hospital stay, less use of opioid pain medication, greater likelihood of returning home after hospital admission, and a lower risk of death compared to nonoperative care. While the preliminary data supporting the use of early internal fixation for minimally displaced LC1 fragility fractures of the pelvis is promising, the necessary evidence to make this significant practice change remains lacking.

The eventual definitive trial has significant potential to change clinical practice and optimize patient outcomes for older adults who experience a minimally displaced LC1 fragility fracture of the pelvis. Treating minimally displaced LC1 fragility fractures of the pelvis with early internal fixation, instead of nonoperative care, would be a paradigm shift in clinical care. This pilot study will demonstrate feasibility of the definitive trial and be used to refine aspects of the study protocol as necessary. If feasibility is successfully demonstrated, the pilot activities will be considered a vanguard phase for the definitive clinical trial.

Adult patients ages 60 years or older with a low-energy lateral compression type 1 (LC1) pelvis fracture with \<10 mm initial displacement of the posterior pelvic ring will be eligible to participate in the study. Patients will be randomized to one of two treatment groups, early internal fixation or nonoperative care with early rehabilitation, defined as at least five days of attempted mobilization by rehabilitation providers. Patients will be followed for 1 year, with visits occurring at 2 weeks, 6 weeks, 4 months, 8 months, and 1 year after fracture. At each follow-up, mortality, ambulation, healthy days at home, and health status will be collected.

The primary objective is to assess feasibility of the trial and to collect information to inform the design of the definitive trial. The feasibility outcomes will include participant enrollment, adherence to treatment allocation, data collection methods, and compliance with key aspects of the protocol.

Вмешательства

• Процедура Early Internal Fixation
  Early internal fixation of the LC1 fragility fracture of the pelvis will be defined as percutaneous anterior and/or posterior pelvic internal fixation with cannulated screw(s), medullary implant(s), or sacroiliac joint fusion device(s). The implant number, design, diameter, thread type (fully-threaded or partially-threaded), sacral segment (S1, S2, S3, or any combination there of), length, trajectory including sacroiliac or transsacral-transiliac, application with or without a washer, and ingrow
• Другое Nonoperative Care with Early Rehabilitation
  Nonoperative care with early rehabilitation will consist of nonoperative treatment of the pelvis fracture, including early consultation of the physical therapist, physiotherapist, or local equivalent rehabilitation provider at the time of randomization for a first attempt at mobilization of the patient within 24 hours of randomization. Patients who are unable to ambulate with assistance after five or more days of attempted mobilization by rehabilitation providers may be considered for delayed in

Первичные конечные точки

• Feasibility of participant enrollment [Срок оценки: 12 months post-randomization]
• Feasibility of adherence to treatment allocation [Срок оценки: 12 months post-randomization]
• Refine data collection methods [Срок оценки: 12 months post-randomization]
• Assess Protocol Compliance [Срок оценки: 12 months post-randomization]

Вторичные конечные точки (1)

• Composite hierarchical outcome of mortality, ambulation, and health days at home. [Срок оценки: 4 months post-randomization]

Критерии участия

Критерии включения

• Patient 60 years of age or older.
• Low energy injury mechanism defined as a fall from standing height.
• LC1 pelvis fracture (AO/OTA 61B1.1 or 61B2.1) confirmed with antero-posterior, inlet, and outlet pelvis radiographs, computed tomography, or magnetic resonance imaging.
• Fracture pattern that could be, in the judgment of the attending surgeon, managed with either early internal fixation or nonoperative care with early rehabilitation.
• Fracture displacement of <10 mm of the posterior pelvic ring on computed tomography of the pelvis.
• Injury occurred within 21 days of screening.

Критерии исключения

• Patient did not ambulate prior to injury.
• Patient has another condition, injury, or fracture that prevents post-operative weightbearing on any extremity.
• Retained implants around the pelvis that precludes or limits either study treatment.
• Infection around the hip (soft tissue or bone).
• Pathologic fracture with a lytic lesion in the pelvis or sacrum that precludes internal fixation.
• Patient is too ill, in the judgement of the attending surgeon, for internal fixation.
• Patient is too ill, in the judgement of the attending surgeon, for nonoperative care.
• Problems, in the judgment of study personnel, with maintaining follow-up with the patient.
• Expected injury survival of less than 12 months.
• Terminal illness with expected survival of less than 12 months.
• Currently enrolled in a study that does not permit co-enrollment.
• Prior enrollment in the trial.
• Unable to obtain informed consent due to language barriers.
• Unable to obtain informed consent because a legally authorized representative (LAR) was unavailable.
• Did not provide informed consent (declined participation).
• Patient or LAR not approached to participate in the trial (missed patient).
• Other reason to exclude the patient, as approved by the Methods Centre.

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

Открытое

Основная цель

Лечение

Центры проведения

США · 12 центров

• University of Arizona — Phoenix
• Keck Medical Center of USC — Los Angeles
• Los Angeles General Medical Center — Los Angeles
• Cedars-Sinai Medical Center — Los Angeles
• University of California, Davis — Sacramento
• University of California San Francisco — San Francisco
• Indiana University — Bloomington
• University of Maryland, Baltimore - R Adams Cowley Shock Trauma Center — Baltimore
• … и ещё 4 центра

Испания · 1 центр

• Research Institute Vall d'Hebrón - Vall d'Hebron University Hospital — Barcelona

Идентификаторы

NCT: NCT06496867 · HS-24-00309

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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