Internal Fixation of Lateral Humeral Condyle Fractures With Absorbable Screws in Children
- Conditions
- Humeral Fractures
- Interventions
- Procedure: Absorbable screw group
- Registration Number
- NCT02733666
- Lead Sponsor
- Children's Hospital of Chongqing Medical University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 86
All participants had been diagnosed with lateral condyle fractures classified as Jacobs type II (unstable) or III
participants had not been diagnosed with lateral condyle fractures classified as Jacobs type II (unstable) or III
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Absorbable screw group Absorbable screw group One absorbable screw was used for fixation in the experimental group
- Primary Outcome Measures
Name Time Method Elbow Motion angle in degree 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
Strength in Newton (N) 6 months after surgery. Compared to the normal hand, the investigators defined it normal to moderate loss and severe loss
Pain 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
stability 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
- Secondary Outcome Measures
Name Time Method