Cemented K-wire Fixation vs Plating for Finger Fractures

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. For comparison, we also included another group of patients who were treated using a mini plate and screw system. Bone healing, range of motion of the fingers, costs of treatments, and patient satisfaction were assessed.

Detailed Description
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Shaft fractures of the proximal phalanx are common injuries that may significantly affect hand function. Good fracture stability to allow early mobilization of joints and thus early return of function. The objective of this report is to introduce a novel external-fixation technique using the combination of K-wires and cement. For comparison, we also included another group of patients who were treated using a mini plate and screw system. A total of 104 patients (131 fingers) were randomly allocated into group A (56 patients) and B (51 patients). Patients in group A were treated with cemented K-wire fixation; and patients in group B were treated with conventional mini-plate. Bone healing, range of motion of the fingers, costs of treatments, and patient satisfaction were assessed.

Official Title
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Randomized Comparison of Cemented K-wire Fixation and Plating of Shaft Fractures of Proximal Phalanges

Conditions
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Closed Fracture of Finger, Finger Fracture Open

Intervention / Treatment
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* Device: Cemented K-wire Fixation
* Device: Plating


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 fracture or open injury with small wound less than 1.5 cm; involvement of proximal phalanges of index to little fingers; shaft fractures; at least 5 mm in length of the most distal and proximal fragments so that the K-wires or screws can be engaged; oblique, spiral, and comminuted fractures; 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; severe open injury or crush injuries; tendon or neurovascular injuries; - involvement of articular surface; old fractures exceeding 15 days because close reduction was most likely difficult; a 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 proximal phalangeal fractures of fingers.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cemented K-wire Fixation<br>The mean age of group A was 41 years (range, 18-63 years). There were 56 male and 11 female patients. The mean time from injury to operation was 5±4.53 days. Injured digits included index (n=24), long (n=19), ring (n=9), and little (n=15) fingers. Types of fractures were transversal (n=31), oblique or spiral (n=14), and comminuted (n=22) fractures. The patients were treated with Cemented K-wire Fixation. | Device: Cemented K-wire Fixation<br>* Fractures were reduced and then fixed with cemented K-wires.<br>Device: Plating<br>* Fractures were reduced and then fixed with Plate.<br>|
| Active Comparator: Plating<br>The mean age of group A was 39 years (range, 19-61 years). There were 51 male and 13 female patients. The mean time from injury to operation was 6±5.53 days. Injured digits included index (n=21), long (n=17), ring (n=10), and little (n=16) fingers. Types of fractures were transversal (n=34), oblique or spiral (n=11), and comminuted (n=19) fractures.The patients were treated with Plating. | Device: Cemented K-wire Fixation<br>* Fractures were reduced and then fixed with cemented K-wires.<br>Device: Plating<br>* Fractures were reduced and then fixed with Plate.<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