Back to resultsInternal Fixation of Lateral Humeral Condyle Fractures With Absorbable Screws in Children
Primary Purpose
Humeral Fractures
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Absorbable screw group
Sponsored by
About this trial
This is an interventional treatment trial for Humeral Fractures focused on measuring Absorbable screw, Internal fixation, Children
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Absorbable screw group
K-wires group
Arm Description
One absorbable screw was used for fixation in the experimental group
two 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.
Outcomes
Primary Outcome Measures
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
Strength in Newton (N)
Compared to the normal hand, the investigators defined it normal to moderate loss and severe loss
stability
Compared to the normal hand, the investigators defined the elbow stability from normal to mild loss , moderate loss and severe loss
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
Secondary Outcome Measures
Full Information
NCT ID
NCT02733666
First Posted
March 25, 2016
Last Updated
April 8, 2016
Sponsor
Children's Hospital of Chongqing Medical University
1. Study Identification
Unique Protocol Identification Number
NCT02733666
Brief Title
Internal Fixation of Lateral Humeral Condyle Fractures With Absorbable Screws in Children
Official Title
Open Reduction and Internal Fixation of Lateral Humeral Condyle Fractures With Absorbable Screws in Children
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Hospital of Chongqing Medical University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Humeral Fractures
Keywords
Absorbable screw, Internal fixation, Children
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Absorbable screw group
Arm Type
Experimental
Arm Description
One absorbable screw was used for fixation in the experimental group
Arm Title
K-wires group
Arm Type
No Intervention
Arm Description
two 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.
Intervention Type
Procedure
Intervention Name(s)
Absorbable screw group
Intervention Description
Open reduction was performed and one absorbable screw was used for fixation in the experimental group
Primary Outcome Measure Information:
Title
Elbow Motion angle in degree
Description
The orginal position was anatomy position （neutral position），Then，test the angle measured in degree of the elbow motion flexion, pronation and supination
Time Frame
6 months after surgery.
Title
Strength in Newton (N)
Description
Compared to the normal hand, the investigators defined it normal to moderate loss and severe loss
Time Frame
6 months after surgery.
Title
stability
Description
Compared to the normal hand, the investigators defined the elbow stability from normal to mild loss , moderate loss and severe loss
Time Frame
6 months after surgery.
Title
Pain
Description
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
Time Frame
6 months after surgery.
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Internal Fixation of Lateral Humeral Condyle Fractures With Absorbable Screws in Children
We'll reach out to this number within 24 hrs