Background <p>Hand fractures are one of the most common skeletal injuries and affect a wide range of the population. There are a variety of treatment methods for fixation of hand fractures including cerclage wires, Kirschner-wires (K-wire), and plates/screw. There is emerging evidence for the effectiveness of intramedullary (IM) screw fixation as an alternative technique, providing stable fixation without the drawbacks of K-wires or plates/screws. Primary research on IM screws for hand fractures is limited, and existing studies assess both metacarpals and phalanges or only metacarpals.</p> Methods <p>This is a protocol for a 1:1 parallel randomized controlled pilot trial that will be conducted at a tertiary academic hospital. Additional sites are awaiting ethical approval across Canada. Patients will be included if they are adults scheduled for operative management of proximal or middle closed phalanx fractures. Exclusion criteria include those that cannot be managed with IM screws or K-wires, fractures affecting both hands, other significant injury to the contralateral upper extremity, other intraarticular fractures, significant concomitant hand trauma, or if they cannot commit to 6 month follow up at our institution. The primary objective of this pilot study will be to assess the feasibility of a national multicenter randomized controlled trial comparing two CR (closed reduction) techniques, i.e. IM screw fixation to K-wire fixation, in adult patients with extraarticular proximal or middle phalanx fracture. The secondary objective will be to describe early clinical outcomes which can be used for future trial sample size calculation.</p> Discussion <p>This multicenter pilot randomized controlled trial comparing IM screw versus K-wire fixation for closed proximal and middle phalanx fractures will provide feasibility criteria to proceed with a full powered randomized controlled trial. Limited high-quality studies have shown superiority of a particular method for hand function and stable fixation. In this study, standardized post-operative outcomes with patient-reported outcomes and range of motion from dedicated hand therapists over a long follow up period will allow for reproducibility and reliability.</p> Trial registration <p>Main site ethical approval was obtained by the Hamilton Integrated Research Ethics Board (17378). The trial was registered with ClinicalTrials.gov (Trial Registration Number: NCT06372067) on 2024-04-17.</p>