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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02733666
• Other study ID #: Yuxi-2016-3-25
• Status: Completed
• Phase: Phase 1
• First received: March 25, 2016
• Last updated: April 8, 2016
• Start date: May 2007
• Est. completion date: December 2015

Study information

• Verified date: April 2016
• Source: Children's Hospital of Chongqing Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Chongqing City
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: December 2015
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

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

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

Intervention

Procedure:
• Absorbable screw group
Open reduction was performed and one absorbable screw was used for fixation in the experimental group

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Chongqing Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Elbow Motion angle in degree	The orginal position was anatomy position (neutral position),Then,test the angle measured in degree of the elbow motion flexion, pronation and supination	6 months after surgery.	Yes
Primary	Strength in Newton (N)	Compared to the normal hand, the investigators defined it normal to moderate loss and severe loss	6 months after surgery.	Yes
Primary	stability	Compared to the normal hand, the investigators defined the elbow stability from normal to mild loss , moderate loss and severe loss	6 months after surgery.	Yes
Primary	Pain	According to the level 0 ~ 10 to pain grading:0 to 3 for mild pain,4 to 6 for moderate pain,7 or more for severe pain	6 months after surgery.	Yes