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
1 other identifier
interventional
86
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started May 2007
Longer than P75 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 25, 2016
CompletedFirst Posted
Study publicly available on registry
April 11, 2016
CompletedApril 12, 2016
April 1, 2016
3.3 years
March 25, 2016
April 8, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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.
Strength in Newton (N)
Compared to the normal hand, the investigators defined it normal to moderate loss and severe loss
6 months after surgery.
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.
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.
Study Arms (2)
Absorbable screw group
EXPERIMENTALOne absorbable screw was used for fixation in the experimental group
K-wires group
NO INTERVENTIONtwo 1.8-mm K-wires were used for the fixation in the control group. The K-wires were the most common used by the orthopaedic surgeon.
Interventions
Open reduction was performed and one absorbable screw was used for fixation in the experimental group
Eligibility Criteria
You may qualify if:
- All participants had been diagnosed with lateral condyle fractures classified as Jacobs type II (unstable) or III
You may not qualify if:
- participants had not been diagnosed with lateral condyle fractures classified as Jacobs type II (unstable) or III
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Vice chief of the orthopeadic department of Children's Hospital of Chongqing Medical Univeristy
Study Record Dates
First Submitted
March 25, 2016
First Posted
April 11, 2016
Study Start
May 1, 2007
Primary Completion
September 1, 2010
Study Completion
December 1, 2015
Last Updated
April 12, 2016
Record last verified: 2016-04