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

NCT ID: NCT02733666

Last Updated: 2016-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2015-12-31

Brief 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

Humeral Fractures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Absorbable screw group

One absorbable screw was used for fixation in the experimental group

Group Type: EXPERIMENTAL

Absorbable screw group

Intervention Type: PROCEDURE

Open reduction was performed and one absorbable screw was used for fixation in the experimental group

K-wires group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Absorbable screw group

Open reduction was performed and one absorbable screw was used for fixation in the experimental group

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital of Chongqing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Yuxi Su

Vice chief of the orthopeadic department of Children's Hospital of Chongqing Medical Univeristy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Yuxi-2016-3-25

Identifier Type: -

Identifier Source: org_study_id