Early Partial Weight-bearing May Improve Functional Recovery Without Increasing Complications Despite This Potential, Limited Randomized Studies Have Evaluated Early Weight-bearing After Pelvic Fixation Surgeries

Официальное название

Immediate Versus Delayed Weight Bearing After Fixation of Pelvic Ring Injuries: Randomized Control Trial

Обзор

The goal of this randomized clinical trial is to compare between the effect of immediate weight bearing (WB) versus delayed weight bearing in improving function, pain, gait, quality of reduction radiologically, muscle strength, and quality of life outcomes in individuals who underwent specific pelvic fixation surgeries.

Вмешательства

• Другое Immediate Partial Weight Bearing
  Immediate Partial Weight Bearing

Первичные конечные точки

• Functional status [Срок оценки: at 12 weeks and at 18 weeks]

Вторичные конечные точки (5)

• core and hip muscle strength [Срок оценки: at 6 weeks and at 12 weeks]
• Pain level [Срок оценки: 1st day, 6 weeks , 12 weeks, 18 weeks]
• Gait [Срок оценки: At 18 weeks]
• Radiological outcome [Срок оценки: 1st day post-operative, 6 weeks, 12 weeks, 18 weeks]
• Patient Quality of life [Срок оценки: at 18 weeks]

Критерии участия

Критерии включения

• Age ≥ 18 to 55 years
• Traumatic fractures indicated for pelvic fixation.
• All Types B after stable anterior and / or posterior fixation.
• Type C, Stable fixation:

Posterior fixation by triangular osteosynthesis. oTrans-iliac trans-sacral screw fixation or Trans iliac plate or posterior infex combined with anterior fixation.

• Excellent to good quality of fracture reduction by Matta and Tornetta radiological assessment.

Критерии исключения

• Associated lower extremity fractures that independently restrict or contraindicate weight-bearing activities.
• Bilateral unstable after fixation pelvic ring disruption.
• Patients with associated spinal cord injury, as neurological deficits may alter gait, functional recovery, and weight-bearing capacity, thereby affecting the validity and generalizability of the outcome measures.
• Current history of acute systemic infection, active Bone inflammatory disease, (e.g., osteomyelitis, chronic non-bacterial osteitis), or malignancy, which may compromise the healing process, confound clinical outcomes, or pose additional medical risks during rehabilitation.
• Uncontrolled Diabetes
• Cancer
• Active infection
• Morbid obesity (BMI > 40)
• Alcohol use disorder (AUD). Alcohol abuse as defined by the National Institute on Alcohol Abuse and Alcoholism: "Drinking at Low Risk for Developing Alcohol Use Disorder: For women, low-risk drinking is defined as no more than 3 drinks on any single day and no more than 7 drinks per week. For men, it is defined as no more than 4 drinks on any single day and no more than 14 drinks per week. NIAAA research shows that only about 2 in 100 people who drink within these limits have AUD".
• Claustrophobia
• Pregnant woman
• Inability to follow study protocol (e.g., lack of ability to attend visits or comprehend instructions)
• Any psychiatric illness that would prevent comprehension of the details and nature of the study and interfere with follow-up clinical visits
• Any clinical finding that would place the patient at health risk, impact the study, or affect the completion of the study

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

Лечение

Центры проведения

Египет · 1 центр

• Trauma Hospital, Assiut University — Asyut

Идентификаторы

NCT: NCT07538726 · 04-2025-300685

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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