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

NCT06372067 | Recruiting DMC

• 1 other identifier: 17378
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hand; Fracture, Phalanx

Outcome Measures

Primary Outcomes (5)

• Percentage of Patient Eligibility - Study Feasibility

  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.

  1 year

• Recruitment rate - Study Feasibility

  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.

  1 year

• Crossover rate - Study Feasibility

  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.

  1 year

• Compliance with intervention rate - Study Feasibility

  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.

  1 year

• Patient retention rate - Study Feasibility

  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.

  1 year

Secondary Outcomes (6)

• Disability of the Arm, Shoulder, and Hand

  baseline, 4 weeks, 12 weeks

• Range of motion

  4 weeks, 8 weeks, 12 weeks

• Grip strength

  8 weeks, 12 weeks

• Return to work

  through study completion, an average of 3 months

• Complications/adverse events

  2 weeks, 4 weeks, 8 weeks, 12 weeks

Study Arms (2)

Intramedullary screw

EXPERIMENTAL

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.

Device: Intramedullary screw

Kirschner wire

ACTIVE COMPARATOR

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.

Device: Kirschner wire

Interventions

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.

Intramedullary screw

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.

Kirschner wire

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

St. Joseph's Healthcare

Hamilton, Ontario, l6l5n4, Canada

RECRUITING

Related Publications (15)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Thabane L, Ma J, Chu R, Cheng J, Ismaila A, Rios LP, Robson R, Thabane M, Giangregorio L, Goldsmith CH. A tutorial on pilot studies: the what, why and how. BMC Med Res Methodol. 2010 Jan 6;10:1. doi: 10.1186/1471-2288-10-1.

  PMID: 20053272 BACKGROUND

• Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA; PAFS consensus group. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ. 2016 Oct 24;355:i5239. doi: 10.1136/bmj.i5239.

  PMID: 27777223 BACKGROUND

• Deshmukh SR, Mousoulis C, Marson BA, Grindlay D, Karantana A; Core Outcome Set for Hand Fractures and Joint Injuries in Adults Group*. Developing a core outcome set for hand fractures and joint injuries in adults: a systematic review. J Hand Surg Eur Vol. 2021 Jun;46(5):488-495. doi: 10.1177/1753193420983719. Epub 2021 Jan 24.

  PMID: 33487059 BACKGROUND

• Gummesson C, Atroshi I, Ekdahl C. The disabilities of the arm, shoulder and hand (DASH) outcome questionnaire: longitudinal construct validity and measuring self-rated health change after surgery. BMC Musculoskelet Disord. 2003 Jun 16;4:11. doi: 10.1186/1471-2474-4-11. Epub 2003 Jun 16.

  PMID: 12809562 BACKGROUND

• Beaton DE, Katz JN, Fossel AH, Wright JG, Tarasuk V, Bombardier C. Measuring the whole or the parts? Validity, reliability, and responsiveness of the Disabilities of the Arm, Shoulder and Hand outcome measure in different regions of the upper extremity. J Hand Ther. 2001 Apr-Jun;14(2):128-46.

  PMID: 11382253 BACKGROUND

• Ziebart C, Bobos P, Furtado R, Dabbagh A, MacDermid J. Patient-reported outcome measures used for hand and wrist disorders: An overview of systematic reviews. J Hand Ther. 2023 Jul-Sep;36(3):719-729. doi: 10.1016/j.jht.2022.10.007. Epub 2023 Mar 11.

  PMID: 36914499 BACKGROUND

• Esteban-Feliu I, Gallardo-Calero I, Barrera-Ochoa S, Lluch-Bergada A, Alabau-Rodriguez S, Mir-Bullo X. Analysis of 3 Different Operative Techniques for Extra-articular Fractures of the Phalanges and Metacarpals. Hand (N Y). 2021 Sep;16(5):595-603. doi: 10.1177/1558944719873144. Epub 2019 Sep 13.

  PMID: 31517524 BACKGROUND

MeSH Terms

Conditions

Fractures, Bone

Interventions

Bone Wires

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Internal Fixators; Prostheses and Implants; Equipment and Supplies; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Surgical Fixation Devices

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: By nature of the interventions in this study, blinding will not be possible for the surgeon or the patient post-operatively.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomized, open-label, pilot randomized controlled trial

Study Record Dates

• First Submitted: April 12, 2024
• First Posted: April 17, 2024
• Study Start: April 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: March 1, 2026
• Last Updated: July 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)