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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Percentage of Patient Eligibility - Study Feasibility — 1 year
  The percentage of patients that are eligible for the study among those that are screened will be recorded. This criteria will be determined to be feasible if at least 70% of screened patients are deemed to be eligible.
• Recruitment rate - Study Feasibility — 1 year
  The percentage of patients that are enrolled in the study among those determined to be eligible will be recorded. To be considered fully enrolled patients must sign the informed consent form, complete baseline demographic questionnaires, and be randomized to a study arm. This criteria will be determined to be feasible if at least 70% of eligible patients are recruited.
• Crossover rate - Study Feasibility — 1 year
  The percentage of patients that crossover to the other arm of the study among those who are eligible and recruited for the study. This criteria will be determined to be feasible if no more than 5% of patients cross over.
• Compliance with intervention rate - Study Feasibility — 1 year
  The percentage of patients that comply with the intervention (appropriate post-operative care, follow-up appointments) among those who are eligible and recruited for the study. This criteria will be determined to be feasible if at least 90% of patients are compliant.
• Patient retention rate - Study Feasibility — 1 year
  The percentage of patients that complete patient-reported questionnaire (Disabilities of the Arm, Shoulder, and Hand) at the 3-month mark, which will be the primary outcome of the main trial. Scores range from 0-100 points, where higher scores indicate greater disability. This criteria will be determined to be feasible if at least 80% of patients are compliant.

Trial sites (1)

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