Recruiting

IM Screw vs. K-wire

Sponsor:

McMaster University

Code:

NCT06372067

Conditions

Hand; Fracture, Phalanx

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Intramedullary screw

Kirschner wire

Study Details

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

Study ID

NCT06372067

Start date

Apr 1, 2025

Status verified date

May, 2025

Completion date

Mar 1, 2026

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. adult patients ≥18 years old
2. scheduled for operative management of extraarticular proximal or middle closed phalanx fracture(s) at the investigators' tertiary hospital
3. feasible to perform closed reduction
4. able to provide informed consent and complete health-related quality of life (HRQoL) questionnaires in English

Exclusion Criteria:

1. other fractures that cannot be managed with IM screws or K-wires
2. other intraarticular fractures
3. significant concomitant hand trauma
4. cannot commit to 3 months of follow up at the investigators' institution

Study Design

Enrollment

34 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

active comparator: 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.

Interventions

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.

Primary outcome measure

  • Percentage of Patient Eligibility - Study Feasibility [ Time Frame: 1 year ]
  • Recruitment rate - Study Feasibility [ Time Frame: 1 year ]
  • Crossover rate - Study Feasibility [ Time Frame: 1 year ]
  • Compliance with intervention rate - Study Feasibility [ Time Frame: 1 year ]
  • Patient retention rate - Study Feasibility [ Time Frame: 1 year ]

Central Contacts and Locations

Locations

St. Joseph's Healthcare

Recruiting

Hamilton, Ontario, Canada, l6l5n4

Contacts

More Information

Sponsor

McMaster University

Last update posted

Jul 22, 2025

Last verified

May, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McMaster University on 2025-07-22.