Early arthroscoPic Stabilization veRsus rehabilitatiOn of the Shoulder in Adolescents With a trauMatic First-time Anterior Shoulder Dislocation ePisode.

Официальное название

Early arthroscoPic Stabilization veRsus rehabilitatiOn of the Shoulder in Adolescents With a trauMatic First-time Anterior Shoulder Dislocation ePisode: A Pilot Prospective CohorT Study (PROMPT-Cohort)

Обзор

Each year within Canada and the US, more than 30,000 children and adolescents will have an injury to their shoulder resulting in a shoulder dislocation. Although the current practice is to manage this initial dislocation without surgery, the vast majority of these children and adolescents will, unfortunately continue to have instability episodes of their shoulder. Recurrent instability can cause damage to the bones and cartilage that form the shoulder resulting in potentially more difficult surgical stabilization, and possibly long-term sequela. To that effect, there is increasing interest to consider early surgical stabilization in this population. This pilot randomized controlled trial (RCT) will evaluate the feasibility of conducting a larger RCT assessing the effect of early arthroscopic stabilization compared to rehabilitation on the rate of repeat shoulder dislocations (recurrent instability), pain, and shoulder function among adolescents (aged 12-18 years) with first-time shoulder dislocations. These patients will be followed for one year.

Вмешательства

• Процедура Arthroscopic stabilization
  Early arthroscopic stabilization with Bankart repair
• Другое Rehabilitation including a period of immobilization followed by physical therapy
  Rehabilitation including a period of immobilization followed by physical therapy

Первичные конечные точки

• Rate of recurrent shoulder dislocation [Срок оценки: 12 months]
• Visual Analogue Scale [Срок оценки: 12 months]

Вторичные конечные точки (3)

• Pediatric and Adolescent Shoulder and Elbow Survey [Срок оценки: 12 months]
• Euro-Qol 5 Dimensions Youth [Срок оценки: 12 months]
• Rate of adverse events (other than recurrent shoulder dislocations) [Срок оценки: 12 months]

Критерии участия

Критерии включения

• Males and females between the ages of 12 and 18, inclusive
• Patients with a first-time traumatic anterior glenohumeral dislocation within the past 5 months
• Anterior glenohumeral dislocation confirmed by radiography, reduction required by medical personnel, or demonstration of anterior apprehension on physical examination following injury to the shoulder
• MRI or MRA demonstrating disruption of the glenohumeral soft tissues (including the labrum, periosteum, or inferior glenohumeral ligament)34 relating to instability
• Patients who have the ability to speak, understand, and read the language of the clinical site
• Provision of informed consent (age 18) or parental consent (ages 12-17, inclusive)
• Provision of informed child assent (ages 12-17, inclusive)

Критерии исключения

• Previous dislocation episodes or instability of the affected shoulder
• Previous surgeries involving the affected shoulder
• History or clinical exam findings of generalized ligamentous laxity (defined as a Beighton score of 4 or more points)35
• History of multi-directional instability of either shoulder
• Concomitant fracture of the tuberosity, humerus, or glenoid (excluding a Bankart or Hill Sachs lesion)
• Bony Bankart lesion exceeding 15% of the glenoid surface (using the best-fit circle method on MRI)36
• Hill Sachs lesion exceeding 15% of the humeral diameter (Measured on transaxial slice of MRI similar to Salomonsson et al.)37
• A neurological injury of the affected arm
• Patients who will likely have problems, in the judgement of the investigator, with maintaining follow-up
• Any other reason(s) the investigator feels is relevant for excluding the patient

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• McMaster University — Hamilton

Идентификаторы

NCT: NCT07459777 · 20071

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗