IM Screw vs. K-wire Fixation of Proximal/Middle Phalanx Fractures

Официальное название

Intramedullary Screw Versus Kirschner Wire Fixation of Extraarticular Proximal and Middle Phalanx Fractures: Pilot Study for a Randomized Controlled Trial

Обзор

When people break their fingers, sometimes surgery is needed to align the bones to heal them properly. There are different ways to fix broken bones in hands, such as plates, pins, or screws. Each method has pros and cons; fixing a broken bone with plates is usually a larger surgery with more cutting but holds the bones very securely. Pins require little to no cutting but the patient needs to immobilize their hand for a few weeks afterwards. Screws are a newer method of fixing broken fingers that requires little cutting and also holds the bones securely. The goal of this study is to compare the effectiveness of using pins versus screws in surgery for broken fingers. The investigators are studying whether using screws leads to better hand function, patient satisfaction, and quicker return to work.

Подробное описание

Hand fractures are one of the most common skeletal injuries and affect a wide range of the population. Commonly affected groups include children and young adults with sports-related injuries, manual labourers with work-related injuries, and the elderly. Although the majority of phalanx fractures may be managed conservatively with good outcomes, operative fixation is indicated for significantly displaced or unstable fracture patterns, and those causing malrotation and scissoring.

There are a variety of options for operative fixation of proximal and middle phalanx fractures, which include closed versus open reduction (CR vs OR) with percutaneous pinning (PP) or internal fixation (IF) techniques. Kirschner wires (K-wire) and plates/screws are the most common CRPP and ORIF techniques. K-wires allow for fracture fixation with minimal soft tissue injury and preserved blood supply. However, patients require prolonged postoperative immobilization and are at risk of malunion and pin tract infection. Conversely, ORIF with plates/screws provide rigid fixation allowing for early mobilization, but require opening of fracture site and often periosteal stripping. Complications with ORIF include adhesions and stiffness.

There is emerging evidence for the effectiveness of intramedullary (IM) screw fixation as an alternative technique for IF. IM screw fixation is a minimally invasive technique that provides rigid fixation of fractures, acting as an internal splint and load-sharing device. Its biomechanical properties have been well-described in the lower extremity orthopedic literature. IM screw fixation may allow for early mobilization without the operative site morbidity of open reduction and its associated complications. Small observational cohort studies have shown favourable outcomes in return to activity, range of motion, time to radiological healing, and grip strength. However, the investigators' literature search revealed a paucity of high quality studies comparing the effectiveness of IM screws with K-wires or other methods of fixation.

The primary objective of this pilot study is to assess the feasibility of a randomized controlled trial comparing two CR techniques, i.e. IM screw fixation to K-wire fixation, in adult patients with extraarticular proximal or middle phalanx fracture at the investigators' tertiary academic hospital. The secondary objective will be to describe early clinical outcomes which can be used for future trial sample size calculation.

Вмешательства

• Устройство Intramedullary screw
  Intramedullary (IM) screw fixation is a minimally invasive technique that provides rigid fixation of fractures, acting as an internal splint and load-sharing device. IM screw fixation may allow for early mobilization without the operative site morbidity of open reduction and its associated complications.
• Устройство Kirschner wire
  Kirschner wire (K-wire) fixation is a minimally invasive technique that provides non-rigid fixation of fractures. K-wires allow for fracture fixation with minimal soft tissue injury and preserved blood supply. However, patients require prolonged postoperative immobilization and are at risk of malunion and pin tract infection.

Первичные конечные точки

• Percentage of Patient Eligibility - Study Feasibility [Срок оценки: 1 year]
• Recruitment rate - Study Feasibility [Срок оценки: 1 year]
• Crossover rate - Study Feasibility [Срок оценки: 1 year]
• Compliance with intervention rate - Study Feasibility [Срок оценки: 1 year]
• Patient retention rate - Study Feasibility [Срок оценки: 1 year]

Вторичные конечные точки (6)

• Disability of the Arm, Shoulder, and Hand [Срок оценки: baseline, 4 weeks, 12 weeks]
• Range of motion [Срок оценки: 4 weeks, 8 weeks, 12 weeks]
• Grip strength [Срок оценки: 8 weeks, 12 weeks]
• Return to work [Срок оценки: through study completion, an average of 3 months]
• Complications/adverse events [Срок оценки: 2 weeks, 4 weeks, 8 weeks, 12 weeks]
• Postoperative pain (visual analogue scale) [Срок оценки: 2 weeks, 4 weeks, 8 weeks, 12 weeks]

Критерии участия

Критерии включения

• adult patients ≥18 years old
• scheduled for operative management of extraarticular proximal or middle closed phalanx fracture(s) at the investigators' tertiary hospital
• feasible to perform closed reduction
• able to provide informed consent and complete health-related quality of life (HRQoL) questionnaires in English

Критерии исключения

• other fractures that cannot be managed with IM screws or K-wires
• other intraarticular fractures
• significant concomitant hand trauma
• cannot commit to 3 months of follow up at the investigators' institution

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

Канада · 1 центр

• St. Joseph's Healthcare — Hamilton

Публикации

• Meals C, Meals R. Hand fractures: a review of current treatment strategies. J Hand Surg Am. 2013 May;38(5):1021-31; quiz 1031. doi: 10.1016/j.jhsa.2013.02.017. PMID 23618458
• Kremer L, Frank J, Lustenberger T, Marzi I, Sander AL. Epidemiology and treatment of phalangeal fractures: conservative treatment is the predominant therapeutic concept. Eur J Trauma Emerg Surg. 2022 Feb;48(1):567-571. doi: 10.1007/s00068-020-01397-y. Epub 2020 May 25. PMID 32451567
• Gaio NM, Kruse LM. Closed Reduction Percutaneous Pinning Versus Open Reduction With Plate and Screw Fixation in Management of Unstable Proximal Phalangeal Fractures: A Systematic Review and Meta-analysis. Hand (N Y). 2025 Jan;20(1):136-142. doi: 10.1177/15589447231189762. Epub 2023 Aug 20. PMID 37599408
• Chao J, Patel A, Shah A. Intramedullary Screw Fixation Comprehensive Technique Guide for Metacarpal and Phalanx Fractures: Pearls and Pitfalls. Plast Reconstr Surg Glob Open. 2021 Oct 26;9(10):e3895. doi: 10.1097/GOX.0000000000003895. eCollection 2021 Oct. PMID 34712548
• Bong MR, Kummer FJ, Koval KJ, Egol KA. Intramedullary nailing of the lower extremity: biomechanics and biology. J Am Acad Orthop Surg. 2007 Feb;15(2):97-106. doi: 10.5435/00124635-200702000-00004. PMID 17277256
• del Pinal F, Moraleda E, Ruas JS, de Piero GH, Cerezal L. Minimally invasive fixation of fractures of the phalanges and metacarpals with intramedullary cannulated headless compression screws. J Hand Surg Am. 2015 Apr;40(4):692-700. doi: 10.1016/j.jhsa.2014.11.023. Epub 2015 Feb 7. PMID 25661294
• Patankar H, Meman FW. Multiple intramedullary nailing of proximal phalangeal fractures of hand. Indian J Orthop. 2008 Jul;42(3):342-6. doi: 10.4103/0019-5413.39573. PMID 19753163
• Verver D, Timmermans L, Klaassen RA, van der Vlies CH, Vos DI, Schep NWL. Treatment of extra-articular proximal and middle phalangeal fractures of the hand: a systematic review. Strategies Trauma Limb Reconstr. 2017 Aug;12(2):63-76. doi: 10.1007/s11751-017-0279-5. Epub 2017 Mar 4. PMID 28260179

Идентификаторы

NCT: NCT06372067 · 17378

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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