Percutaneous Pinning vs Orthosis and Early Mobilization

Официальное название

A Randomized Comparison Between Percutaneous Pinning and Non-surgical Management of Proximal Phalangeal Fractures

Обзор

This study aims at investigating if splinting and early mobilization is a better method, regarding range of motion, for treating fractures of the base phalanx of the fingers compared to surgery with pinning. This will be achieved through a randomised clinical trial comparing the two methods.

Подробное описание

Proximal phalangeal fractures of the hand are very common and affect patients of all ages. . Most fractures heal without complications but these injuries can result in impaired hand function and prolonged inability to work and perform activities of daily living. If there is a dislocation that cannot easily be repositioned to a stable position, surgery might be required. Surgery is often performed with percutaneous pinning and immobilisation in plaster for 4 weeks. Good results of non-surgical treatment with a splint that allows immediate mobilization of the interphalangeal joints has been reported. This study will compare these two methods for treating fractures of the base phalanx of the fingers. Recruited patients will be randomized to one of the two treatment arms: 1. surgery with pinning 2. conservative treatment with a splint. Primary outcome is total active range of motion in the affected finger at 3, 6 months and 1 , 3 years. Secondary outcomes are number of sick days and various patient related outcome measures.

Вмешательства

• Процедура Percutaneous pinning
  Closed reduction, percutaneous pinning and plaster
• Процедура Conservative treatment
  Closed reduction, custom made orthosis and early mobilization

Первичные конечные точки

• TAM (Total active range of motion) [Срок оценки: 3 months]
• TAM (Total active range of motion) [Срок оценки: 6 months]
• TAM (Total active range of motion) [Срок оценки: 1 year]
• TAM (Total active range of motion) [Срок оценки: 3 years]

Вторичные конечные точки (6)

• Number of sick days [Срок оценки: 3 months]
• Patient related outcome measure DASH [Срок оценки: 3, 6 months and 1 and 3 years]
• Patient related outcome measure HADS [Срок оценки: 3, 6 months and 1 and 3 years]
• Patient related outcome measure EQ-5D [Срок оценки: 3, 6 months and 1 and 3 years]
• Patient related outcome measure HQ-8 [Срок оценки: 3, 6 months and 1 and 3 years]
• Grips strength [Срок оценки: 3, 6 months and 1 and 3 years]

Критерии участия

Критерии включения

-Fractures of the base phalanx of digit 2-5 in the hand.

Критерии исключения

• Fracture older than 2 weeks.
• More than 25° of sagittal plane and/or 10° lateral angulation after reposition.
• Intra-articular step >1mm.
• Associated fractures in other bones (i e metacarpals, middle and distal phalanges) and/or tendon and nerve injuries in any finger.
• Open fractures.
• Patient age <18 years.
• Inability to co-operate with the follow-up protocol (i.e. language difficulties, severe psychiatric disorder, cognitive impairment, drug addiction).

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

Швеция · 1 центр

• Dept Hand Surgery — Stockholm

Идентификаторы

NCT: NCT04561661 · Frakturstudien

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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