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

Humeral Fractures Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fractures, Bone
• Humeral Fractures

• NCT number: NCT02733666
• Study type: Interventional
• Source: Children's Hospital of Chongqing Medical University
• Status: Completed
• Phase: Phase 1
• Start date: May 2007
• Completion date: December 2015