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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines two surgical methods for fixing broken fingers: intramedullary screws and K-wires (Kirschner wires). The goal is to determine which method enables faster return to daily activities and better hand function. Screws may allow quicker movement, while K-wires require the hand to remain still longer. Ideal participants are adults needing surgery for specific finger fractures who can attend follow-up appointments for 3 months. As an unphased trial, participants contribute to valuable research that may enhance surgical outcomes for future patients.

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 prior data suggests that these methods are safe for fixing broken fingers?

Research has shown that using intramedullary screws to fix broken fingers is generally safe. In one study, only 4.4% of cases experienced major problems. Most patients expressed satisfaction with the treatment, with 94.6% stating they would choose it again. The main issues include the screw protruding, bones shifting, and infections, though these are uncommon.

The Kirschner wire (K-wire) procedure is also considered safe but carries some risks. Patients might need to keep their hand still for an extended period, and there is a chance of bones healing incorrectly or infections at the wire entry site.

Overall, both methods are well-tolerated, each with distinct pros and cons. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

The intramedullary screw is unique because it offers a minimally invasive way to fix broken fingers with rigid support, acting like an internal splint. This technique allows patients to start moving their fingers sooner without the typical risks that come with more invasive surgery. Researchers are excited about this approach because it could reduce the need for prolonged immobilization and lower the chances of complications, like infections, compared to the traditional Kirschner wire method.

What evidence suggests that this trial's treatments could be effective for broken fingers?

This trial will compare two methods for treating broken fingers: intramedullary screw fixation and Kirschner wire (K-wire) fixation. Studies have shown that using a small screw inside the bone effectively treats broken fingers. This method provides stable support for the healing bone with minimal cutting, often resulting in good hand function and a quicker return to normal activities. Patients report high satisfaction and a low rate of complications, such as infections. In comparison, K-wire fixation is also minimally invasive but usually requires the hand to remain still for a longer period, which can increase the risk of complications. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

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 can give consent and fill out health questionnaires in English.

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

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11571476/

Intramedullary Screw Fixation of Proximal Phalangeal Fractures Intramedullary screw fixation is a safe and effective method of stabilizing extra-articular proximal phalangeal fractures in the short to medium term.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11993536/

Intramedullary Compression Screw Fixation of Proximal ... This updated systematic review finds good functional outcomes and a low complication rate following the use of IMS fixation for proximal phalangeal fractures.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0363502323006901

Intramedullary Compression Screw Fixation for Middle ... It offers a favorable postoperative range of motion, good duration for return to function, excellent rates of complication, and low pain scores.

4. jhsgo.org jhsgo.org/article/S2589-5141(23)00174-3/fulltext

Outcomes Following Fully Threaded Intramedullary Nailing ... Our findings suggest that the TIMN allows for a reliable return to work and physical activity, high patient satisfaction, low complication rate, and minimal ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06372067

IM Screw vs. K-wire Fixation of Proximal/Middle Phalanx ... IM screw fixation may allow for early mobilization without the operative site morbidity of open reduction and its associated complications.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12511004/

Outcomes of Metacarpal Shaft Fractures Treated by Open ... Commonly reported complications following ORIF with PS include stiffness, extensor lag, tendon adhesions, and revision surgery for hardware ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S258951412400197X

Intramedullary Fixation for Metacarpal Fractures: A Multi- ... Intramedullary fixation is a reliable technique for treatment of extra-articular metacarpal fractures with satisfactory patient-reported outcomes.

8. journals.sagepub.com journals.sagepub.com/doi/10.1177/15589447241235339

Intramedullary Screw Fixation of Proximal Phalangeal ... A total of 4.4% of fractures sustained a major complication, and 94.6% of patients reported willingness to undergo intramedullary screw fixation again.

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S036350231831462X

Patient-Reported Outcomes and Complications After ... We compared patient-reported outcomes measures and complications of Kirschner wire (K-wire), lag-screw and plate fixation of proximal phalanx fractures.