Clinical Trials Directory

Trials / Completed

CompletedNCT02733666

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

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

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
86 (actual)
Sponsor
Children's Hospital of Chongqing Medical University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
PROCEDUREAbsorbable screw groupOpen reduction was performed and one absorbable screw was used for fixation in the experimental group

Timeline

Start date
2007-05-01
Primary completion
2010-09-01
Completion
2015-12-01
First posted
2016-04-11
Last updated
2016-04-12

Source: ClinicalTrials.gov record NCT02733666. Inclusion in this directory is not an endorsement.