Cemented K-wire Fixation vs Open Transfixion Pinning

The Second Hospital of Qinhuangdao

Status: Completed

Conditions: Finger Fracture; Closed Fracture of Finger

Treatments: Device: Transfixion Pinning; Device: Cemented K-wire

Study type: Interventional

Funder types: Other

Identifiers

NCT03082872

THHMU201763

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 98 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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98 participants in 2 patient groups

Cemented K-wire Fixation

Experimental group

Description:

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

Treatment:

Device: Transfixion Pinning

Device: Cemented K-wire

Open Transfixion Pinning

Experimental group

Description:

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

Treatment:

Device: Transfixion Pinning

Device: Cemented K-wire