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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02733666
Enrollment
86
Registered
2016-04-11
Start date
2007-05-31
Completion date
2015-12-31
Last updated
2016-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Humeral Fractures

Keywords

Absorbable screw, Internal fixation, Children

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.

Interventions

PROCEDUREAbsorbable screw group

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

Sponsors

Children's Hospital of Chongqing Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Elbow Motion angle in degree6 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
stability6 months after surgery.Compared to the normal hand, the investigators defined the elbow stability from normal to mild loss , moderate loss and severe loss
Pain6 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026