Clinical trial NCT06372067: IM Screw vs. K-wire Fixation of Proximal/Middle Phalanx Fractures
Official title: Intramedullary Screw Versus Kirschner Wire Fixation of Extraarticular Proximal and Middle Phalanx Fractures: Pilot Study for a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hand; Fracture, Phalanx
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2024-04-17
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, open-label, pilot randomized controlled trial
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. adult patients ≥18 years old
2. scheduled for operative management of extraarticular proximal or middle closed phalanx fracture 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. multiple fractured fingers
2. significant concomitant hand trauma
3. cannot commit to 3 months of follow up at the investigators' institution

Primary outcomes:
measure: Percentage of Patient Eligibility - Study Feasibility
timeFrame: 1 year
measure: Recruitment rate - Study Feasibility
timeFrame: 1 year
measure: Crossover rate - Study Feasibility
timeFrame: 1 year
measure: Compliance with intervention rate - Study Feasibility
timeFrame: 1 year
measure: Patient retention rate - Study Feasibility
timeFrame: 1 year
Secondary outcomes:
measure: Disability of the Arm, Shoulder, and Hand
timeFrame: baseline, 4 weeks, 12 weeks
measure: Range of motion
timeFrame: 4 weeks, 8 weeks, 12 weeks
measure: Grip strength
timeFrame: 8 weeks, 12 weeks
measure: Return to work
timeFrame: through study completion, an average of 3 months
measure: Complications/adverse events
timeFrame: 2 weeks, 4 weeks, 8 weeks, 12 weeks
measure: Postoperative pain (visual analogue scale)
timeFrame: 2 weeks, 4 weeks, 8 weeks, 12 weeks
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare
state: Ontario
Study officials:
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