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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06372067
Study type Interventional
Source McMaster University
Contact
Status Not yet recruiting
Phase N/A
Start date July 1, 2024
Completion date March 1, 2026