Cemented K-wire Fixation vs Open Transfixion Pinning

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-01

Study Completion Date

2015-01-30

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.

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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.

Conditions

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Closed Fracture of Finger Finger Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients with middle proximal fractures of fingers

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Blinded

Study Groups

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Cemented K-wire Fixation

Fractures were transverse (n=32), short oblique or spiral (n=5), and comminuted (n=14) fractures.

Group Type EXPERIMENTAL

Cemented K-wire

Intervention Type DEVICE

Fracture of proximal phalanx was treated with Cemented K-wire.

Transfixion Pinning

Intervention Type DEVICE

Fracture of proximal phalanx was treated with transfixion pinning.

Open Transfixion Pinning

Fractures were transverse (n=28), short oblique or spiral (n=4), and comminuted (n=15) fractures.

Group Type EXPERIMENTAL

Cemented K-wire

Intervention Type DEVICE

Fracture of proximal phalanx was treated with Cemented K-wire.

Transfixion Pinning

Intervention Type DEVICE

Fracture of proximal phalanx was treated with transfixion pinning.

Interventions

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Cemented K-wire

Fracture of proximal phalanx was treated with Cemented K-wire.

Intervention Type DEVICE

Transfixion Pinning

Fracture of proximal phalanx was treated with transfixion pinning.

Intervention Type DEVICE

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No