Intramedullary Screw Fixation Versus Closed Reduction and Percutaneous Pinning With Cast Immobilization

Официальное название

Intramedullary Screw Fixation Versus Closed Reduction and Percutaneous Pinning With Cast Immobilization in the Treatment of Phalangeal and Metacarpal Fractures: A Randomized Control Trial

Обзор

Broken bones in the hand are common injuries that can make it hard to move fingers, grip objects, and return to work. When these breaks happen in the long bones of the hand (called metacarpals and phalanges), surgery is often needed to hold the bones in the right place while they heal. There are a few different ways surgeons can fix these broken bones. Two common methods are: CRPP (Closed Reduction and Percutaneous Pinning): The bones are moved back into place without opening the skin, and thin metal pins are used to hold them. IMSF (Intramedullary Screw Fixation): A small screw is placed inside the bone to hold it in position. Another approach sometimes used for larger bones in the hand is ORIF (Open Reduction and Internal Fixation), where the bone is exposed through a small incision and held with plates or screws. This study will compare how well these methods work. Investigators want to find out if using an intramedullary screw (IMSF) helps patients heal faster and move their hands more easily compared to the other common methods (CRPP and ORIF). Investigators will look at how quickly patients regain movement, how soon they can return to work, how satisfied they are with their recovery, and whether there are any problems or complications from surgery. To do this, investigators will run a randomized controlled trial-this means patients will be stratified based on fracture location (metacarpals or phalanges) and randomly assigned to a treatment arm. For patients with metacarpal fractures, investigators will compare IMSF vs CRPP vs ORIF using a dorsal plate. For patients with proximal or middle phalangeal fractures investigators will compare IMSF to CRPP. Investigators will measure their recovery using both clinical tests and patient surveys over time. The results of this research will help surgeons choose the best and safest way to treat hand fractures so patients can heal faster and get back to their daily lives sooner

Подробное описание

Metacarpal and phalangeal fractures are common traumatic injuries of the hand.1 Many can be treated conservatively, but when there is malalignment or instability, operative reduction and stabilization is required.2,3 Closed reduction and percutaneous pinning (CRPP), or open reduction and internal fixation (ORIF) using plates, screws, or wires are common methods of treatment.4-6 Percutaneous fixation allows stabilization of fractures with minimal soft tissue disruption,7-11 and although technically challenging, if successful, secondary complications such as tendon adhesions and abnormal scarring are uncommon.9 Conversely, open methods require broader exposure resulting in swelling and increased risk of scarring9, but facilitates early active motion allowing earlier return to function.3,10 Intramedullary screw fixation (IMSF) is a technique that is gaining popularity12,13 as it maintains the minimally invasive benefits of CRPP while providing stability similar to ORIF.14 In correctly selected fractures, IM screws facilitate early recovery with minimal down time, allowing expedited treatment and less loss of productivity.3,12,13 Investigators believe IM screws have notable advantages compared to CRPP. Allowing earlier rehabilitation, less external immobilization, and earlier functional recovery has potential to improve quality of life and reduce productivity loss.

These procedures are used currently within St. Joseph's Health Care London but there is debate regarding there efficacy and specific surgical technique varies amongst practitioners. The comparison comes between the specific surgical intervention, as although some surgeons have rapidly adapted this technique, is efficacy compared to more classic techniques has not been explored using high level studies, leaving its specific utility less clear.

Вмешательства

• Процедура ORIF
  Open Reduction and Internal Fixation
• Процедура IMSF
  Intramedullary Screw Fixation
• Процедура CRPP
  Closed Reduction and Percutaneous Pinning

Первичные конечные точки

• Range of Motion [Срок оценки: from enrollment to the of end of the study at 12 months]
• Grip strength [Срок оценки: from enrollment to the of end of the study at 12 months]
• Visual Analogue Scale for pain [Срок оценки: from enrollment to the of end of the study at 12 months]

Вторичные конечные точки (6)

• Return to Work [Срок оценки: from enrollment to the of end of the study at 12 months]
• Complications [Срок оценки: from enrollment to the of end of the study at 12 months]
• Quick Dash,the Quick Disabilities of the Arm, Shoulder, and Hand [Срок оценки: from enrollment to the of end of the study at 12 months]
• Single assessment numeric evaluation (SANE) [Срок оценки: from enrollment to the of end of the study at 12 months]
• EuroQol 5-Dimensional questionnaire [Срок оценки: from enrollment to the of end of the study at 12 months]
• Patient-Rated Wrist/Hand Evaluation [Срок оценки: from enrollment to the of end of the study at 12 months]

Критерии участия

Критерии включения

The MC arm:

• surgical management within 10 days of injury
• extraarticular fractures, clinical scissoring
• sagittal angulation in accordance with accepted norms (Table 1)
• shortening >5mm, translation >50%.

The phalangeal arm:

• surgical management within 10 days of injury
• extraarticular fractures, clinical scissoring
• sagittal angulation >20°
• shortening >2mm
• translation >50%.

Критерии исключения

• < 18 years old
• unable to read English, provide consent, or return to follow-up.
• Injuries with concomitant soft tissues loss, tendon injury, nerve injury, infection, or fractures with severe comminution
• history of prior surgical management of a fracture of the ipsilateral hand

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

Канада · 1 центр

• St. Joseph's Health Care London — London

Идентификаторы

NCT: NCT07616947 · 127846 · 127846

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗