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Completed

NCT Number: NCT02733666

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

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.

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Key information

Conditions

Humeral Fractures Arm Injuries Fractures, Bone Wounds and Injuries

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Absorbable screw group

Procedure

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

Primary outcomes

  1. Elbow Motion angle in degree

    Time frame: 6 months after surgery.

    The orginal position was anatomy position （neutral position），Then，test the angle measured in degree of the elbow motion flexion, pronation and supination

  2. Strength in Newton (N)

    Time frame: 6 months after surgery.

    Compared to the normal hand, the investigators defined it normal to moderate loss and severe loss

  3. stability

    Time frame: 6 months after surgery.

    Compared to the normal hand, the investigators defined the elbow stability from normal to mild loss , moderate loss and severe loss

  4. Pain

    Time frame: 6 months after surgery.

    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

Sponsors and collaborators

Lead sponsor

Children's Hospital of Chongqing Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2010
Study completion
2015
First posted
Apr 11, 2016
Registry last updated
Apr 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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