Cemented K-wire Fixation vs Plating for Finger Fractures (CKFPFF)

The Second Hospital of Qinhuangdao

Status: Completed

Conditions: Closed Fracture of Finger; Finger Fracture Open

Treatments: Device: Cemented K-wire Fixation; Device: Plating

Study type: Interventional

Funder types: Other

Identifiers

NCT03031015

THHMU201701

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 131 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 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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131 participants in 2 patient groups

Cemented K-wire Fixation

Experimental group

Description:

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.

Treatment:

Device: Cemented K-wire Fixation

Device: Plating

Plating

Active Comparator group

Description:

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.

Treatment:

Device: Cemented K-wire Fixation

Device: Plating