Intramedullary Screw vs. K-wire Fixation for Broken Finger

(HANDFIX Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: McMaster University

Disqualifiers: Multiple fractured fingers, significant hand trauma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: Surgery and immediate postoperative period

34 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Intramedullary screw and Kirschner wire for broken fingers?

Research shows that using Kirschner wires for fixing broken bones in the hand, like the metacarpal bones, is effective and safe, with most patients regaining full finger movement. Additionally, studies suggest that intramedullary nails, which are similar to screws, provide strong support for bone healing. ^{1 2 3 4 5}

What safety data exists for K-wire fixation in humans?

K-wire fixation is generally safe but can have complications like infections, wire breakage, and other issues, with complication rates reported up to 18%. Proper technique and supervision can help reduce these risks. ^{5 6 7 8 9}

How does intramedullary screw fixation differ from K-wire fixation for broken fingers?

Intramedullary screw fixation is a newer technique that offers a more stable and potentially less invasive option compared to traditional Kirschner wire (K-wire) fixation, which is known for being low-cost but can have complications like pin tract infections. The intramedullary screw may provide better biomechanical stability and reduce the risk of soft tissue trauma, allowing for quicker recovery and fewer complications. ^{1 2 10 11 12}

Eligibility Criteria

This trial is for adults over 18 with a closed fracture in the upper or middle part of their finger, who are scheduled for surgery at the investigators' hospital. Participants must be able to give informed consent and fill out health questionnaires in English.

Inclusion Criteria

I am scheduled for surgery on a finger fracture at the hospital.

I can give consent and fill out health questionnaires in English.

It's possible to realign my bones without open surgery.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either intramedullary screw fixation or Kirschner wire fixation for proximal or middle phalanx fractures

Surgery and immediate postoperative period

Postoperative Immobilization

Participants with Kirschner wire fixation require prolonged postoperative immobilization

4-8 weeks

Follow-up

Participants are monitored for safety, effectiveness, and functional outcomes after treatment

12 weeks

Regular visits at 2, 4, 8, and 12 weeks

Treatment Details

Interventions

• Intramedullary screw
• Kirschner wire

Trial Overview The study compares two surgical methods for fixing broken fingers: using an intramedullary screw (a newer method that requires minimal cutting) versus a Kirschner wire (pins requiring little to no cutting but immobilization after). It aims to see which leads to better hand function, satisfaction, and faster return to work.

Participant Groups

Group I: Intramedullary screw Experimental Treatment 1 Intervention

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.

Group II: Kirschner wire Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials

936

Recruited

2,630,000+

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

[Intramedullary Kirschner wire osteosynthesis in treatment of distal metacarpal fractures]. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Threaded Intramedullary Nails Are Biomechanically Superior to Crossed K-wires for Metacarpal Neck Fractures. [2023]

3. Scotland pubmed.ncbi.nlm.nih.gov

Comparison between percutaneous transverse fixation and intramedullary K-wires in treating closed fractures of the metacarpal neck of the little finger. [2016]

4. Korea (South) pubmed.ncbi.nlm.nih.gov

Comparison between Intramedullary Nailing and Percutaneous K-Wire Fixation for Fractures in the Distal Third of the Metacarpal Bone. [2020]

5. Belgium pubmed.ncbi.nlm.nih.gov

Internal fixation with Kirschner wires is as efficient as rigid screw fixation in scaphoid fracture: long-term functional outcome. [2019]

6. Germany pubmed.ncbi.nlm.nih.gov

Complications of K-wire fixation of fractures and dislocations in the hand and wrist. [2022]

7. England pubmed.ncbi.nlm.nih.gov

A review of K-wire related complications in the emergency management of paediatric upper extremity trauma. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Outcomes of an aseptic technique for Kirschner wire percutaneous pinning in the hand and wrist. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Kirschner Wire Breakage during Removal Requiring Retrieval. [2020]

10. Pakistan pubmed.ncbi.nlm.nih.gov

Kirschner wire pin tract infection rates between percutaneous and buried wires in treating metacarpal and phalangeal fractures. [2006]

11. United States pubmed.ncbi.nlm.nih.gov

Cost Comparison of Kirschner Wire Versus Intramedullary Screw Fixation of Metacarpal and Phalangeal Fractures. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Comparative Study of Intramedullary Hammertoe Fixation. [2019]