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NCT Number: NCT06372067

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

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.

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Key information

Conditions

Hand; Fracture, Phalanx Fractures, Bone Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Joseph's Healthcare

Hamilton, Ontario, l6l5n4, Canada

Location status: Recruiting

Location contact

Emily Dunn, MSc

CONTACT

[email protected]

905-522-1155

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Intramedullary screw

Device

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

Device

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.

Primary outcomes

  1. Percentage of Patient Eligibility - Study Feasibility

    Time frame: 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.

  2. Recruitment rate - Study Feasibility

    Time frame: 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.

  3. Crossover rate - Study Feasibility

    Time frame: 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.

  4. Compliance with intervention rate - Study Feasibility

    Time frame: 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.

  5. Patient retention rate - Study Feasibility

    Time frame: 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.

Secondary outcomes

  1. Disability of the Arm, Shoulder, and Hand

    Time frame: baseline, 4 weeks, 12 weeks

    The Disability of the Arm, Shoulder, and Hand is a region-specific PROM that has been shown to be valid, reliable, and responsive to change in measuring patient-important domains pertaining to the upper extremity. Scores range from 0-100 points, where higher scores indicate greater disability. In trauma populations, the Disability of the Arm, Shoulder, and Hand has been shown to have excellent internal consistency (0.98) and test-retest probability (intraclass correlation coefficient [ICC] = 0.98). The Disability of the Arm, Shoulder, and Hand has also been reported to have good criterion validity, construct validity and responsiveness in hand trauma patients.

  2. Range of motion

    Time frame: 4 weeks, 8 weeks, 12 weeks

    Range of motion of the affected finger, compared to the contralateral finger. As measured and reported by hand therapist appointments which are part of routine care at the investigators' institution.

  3. Grip strength

    Time frame: 8 weeks, 12 weeks

    Grip strength of the affected hand, compared to the contralateral hand. As measured and reported by hand therapist appointments which are part of routine care at the investigators' institution.

  4. Return to work

    Time frame: through study completion, an average of 3 months

    Time of patient-reported return to work or surgeon clearance for return to work.

  5. Complications/adverse events

    Time frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks

    Post-operative complications/adverse events include but are not limited to stiffness, delayed union, non-union, malunion, infection, hardware removal, reoperation.

  6. Postoperative pain (visual analogue scale)

    Time frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks

    Pain will be measured postoperative on the visual analogue scale, which ranges from 0-10. Higher scores indicate greater pain.

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Registry information

Official study title

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

Acronym: HANDFIX

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Apr 17, 2024
Registry last updated
Jul 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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