Cemented K-wire Fixation vs Open Transfixion Pinning

Study Overview
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Brief Summary
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To introduce a novel external-fixation technique using the combination of K-wires and cement, and the objective of this report is also to compare the technique with conventional open transfixion pinning.

Detailed Description
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Shaft fractures of the middle phalanx are common injuries that are often difficult to treat. Currently, fracture fixation is usually achieved by using K-wire, but pin configurations are controversial.The objective of this report is to introduce treatment of shaft fractures of middle phalanx with a novel external-fixation technique using combined K-wires and cement. For comparison, we also included another group of patients who were treated using open transfixion pinning.A total of 98 patients (98 fingers) with shaft fractures of middle phalanx were randomly allocated to group A (n=51) and B (n=47). Fingers in group A were treated with cemented K-wire fixation, and fingers in group B were treated using conventional open transfixion pinning. Time of bone healing, range of motion of the fingers, and joint motion were assessed. A p<0.05 was considered statistically significant.

Official Title
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Randomized Comparison Between Cemented K-wire Fixation vs Open Transfixion Pinning for the Treatment of Shaft Fractures of Middle Phalanges

Conditions
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Closed Fracture of Finger, Finger Fracture

Intervention / Treatment
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* Device: Cemented K-wire
* Device: Transfixion Pinning


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patient aged between 18 and 65 years; acute fractures within 15 days; closed fractures or fractures with small open wound less than 1.5 cm; involvement of single middle phalanges of index to little fingers; shaft fractures; at least 5 mm in length of the most distal and proximal fragments so that K-wires can be secured; transversal, short oblique or spiral fractures; comminuted fractures of middle third phalanx; normal opposite hand for comparison. Exclusion Criteria: patients younger than 18 years are excluded because of skeletal immaturity; patients older than 65 years are excluded because of possible osteoporosis; multiple finger involvement; severe open injury or crush injuries; combined tendon or neurovascular injuries; involvement of articular surface; old fractures exceeding 15 days because close reduction most likely became difficult; combined tendon, nerve, or artery injuries or diseases; diabetes, gout, ganglion; osseous tumors, and other disease affecting bony structures and joint motion; patients who declined to participate.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients with middle proximal fractures of fingers
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cemented K-wire Fixation<br>Fractures were transverse (n=32), short oblique or spiral (n=5), and comminuted (n=14) fractures. | Device: Cemented K-wire<br>* Fracture of proximal phalanx was treated with Cemented K-wire.<br>Device: Transfixion Pinning<br>* Fracture of proximal phalanx was treated with transfixion pinning.<br>|
| Experimental: Open Transfixion Pinning<br>Fractures were transverse (n=28), short oblique or spiral (n=4), and comminuted (n=15) fractures. | Device: Cemented K-wire<br>* Fracture of proximal phalanx was treated with Cemented K-wire.<br>Device: Transfixion Pinning<br>* Fracture of proximal phalanx was treated with transfixion pinning.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone healing | Time of bone healing | Up to 12 weeks. From date of randomization until the date of first documented progression from any cause, which is assessed up to 12 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Joint motion | Range of motion of MCP, PIP, and DIP joints | Up to 2 years. From date of randomization until the date of second documented progression from any cause, which is assessed up to 2 years. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Reduction, Fracture