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Internal Fixation of Lateral Humeral Condyle Fractures With Absorbable Screws in Children

C

Chongqing Medical University

Status and phase

Completed
Phase 1

Conditions

Humeral Fractures

Treatments

Procedure: Absorbable screw group

Study type

Interventional

Funder types

Other

Identifiers

NCT02733666
Yuxi-2016-3-25

Details and patient eligibility

About

Lateral humeral condyle fractures are the second most common elbow fractures in children. Displaced and rotated fractures require stabilization and reduction. Kirschner wires (K-wires) are most commonly used for fracture fixation. Here, the investigators introduce a new fixation method involving absorbable screws. The investigators aimed to determine if it is feasible to treat lateral humeral condyle fractures with absorbable screws by comparing the functional outcomes obtained using screw fixation vs. K-wire fixation.

Full description

Methods: Between May 2007 and September 2010, 86 participants (age, 1.6-13 years; average age, 6.7 years) were randomly divided into two groups. All participants had been diagnosed with lateral condyle fractures classified as Jacobs type II (unstable) or III. Closed reduction failed in all participants. Therefore, open reduction was performed under general anesthesia. One absorbable screw was used for fixation in the experimental group, while two 1.8-mm K-wires were used in the control group. At 4-6 weeks postoperatively, the participants' plaster casts were removed, and functional training was started.

Enrollment

86 patients

Sex

All

Ages

Under 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

All participants had been diagnosed with lateral condyle fractures classified as Jacobs type II (unstable) or III

Exclusion criteria

participants had not been diagnosed with lateral condyle fractures classified as Jacobs type II (unstable) or III

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

86 participants in 2 patient groups

Absorbable screw group
Experimental group
Description:
One absorbable screw was used for fixation in the experimental group
Treatment:
Procedure: Absorbable screw group
K-wires group
No Intervention group
Description:
two 1.8-mm K-wires were used for the fixation in the control group. The K-wires were the most common used by the orthopaedic surgeon.

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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