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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04424498
Other study ID # CQMU20200016
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2019
Est. completion date December 1, 2019

Study information

Verified date June 2020
Source Children's Hospital of Chongqing Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study aimed to evaluate the outcomes of using absorbable rods and Kirschner Wires technique for severe displaced radial neck fractures combined with olecranon fractures in children.


Description:

The most common fracture in children is the elbow fracture, and the three most common elbow fractures are supracondylar, lateral condylar, and medial epicondylar fractures. Elbow fractures are easy to diagnose and the treatment modalities are studied often. However, proximal radius fractures, which include radial neck and head fractures, remain challenging to diagnose and manage. In addition, proximal radius fractures are often combined with other fractures, most commonly, an olecranon fracture. Most radial neck fractures can be treated conservatively if the displacement is less than 3 mm and the angle is less than 30ยบ. However, for severe Judet type III and type IV radial neck fractures, surgery is inevitable.

This study focused on radial neck fractures combined with an olecranon fracture. In this study, absorbable rods were used for fixation of radial head fractures, and with no need for removal of the inner fixation, we performed anatomy reduction via the same incision with direct vision of the olecranon, and we were able to fix the fractures with Kirschner wires (K-wires). In this retrospective study, we aimed to evaluate a treatment method for severe displaced radial neck combined with olecranon fractures in children using a Boyd incision, absorbable rods, and K-wires.


Recruitment information / eligibility

Status Completed
Enrollment 31
Est. completion date December 1, 2019
Est. primary completion date December 1, 2019
Accepts healthy volunteers No
Gender All
Age group 3 Years to 13 Years
Eligibility Inclusion Criteria:

- open reduction of severe radial neck fractures combined with an olecranon fractures in the same elbow

- fixation performed using absorbable rods and K-wires

Exclusion Criteria:

- single radial head fractures or single olecranon fractures

- fixation performed with bands

- old fractures,

- Boyd incision was not used,

- guardians did not agree with the surgery

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Absorbable Rods and Kirschner Wires
A Boyd incision was applied in all patients; olecranon fractures were reduced first and fixed with Kirschner wires. Then, the displaced radial neck fractures were reduced and fixed using absorbable rods.

Locations

Country Name City State
China Children's Hospital of Chongqing Medical University Chongqing Chongqing

Sponsors (1)

Lead Sponsor Collaborator
Children's Hospital of Chongqing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mayo Elbow Performance Index score MEPI results were categorized as follows: >90 points, excellent; 81-90 points, good; 61-80 points, fair; and <60 points, poor. 3th month after surgery
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