Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00207870
Status:
WITHDRAWN
Last Update Posted:
2014-07-22
First Post:
2005-09-13
Brief Title:
Type II Supracondylar Fractures in Children
Sponsor:
Childrens Healthcare of Atlanta
Organization:
Childrens Healthcare of Atlanta
Study Overview
Official Title:
Comparison of Crossed Pin Versus Lateral-Entry Pin Fixation for Type II Supracondylar Fractures in Children A Prospective Randomized Trial
Status:
WITHDRAWN
Status Verified Date:
2011-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Supracondylar fractures are the most common elbow fractures in children In the current orthopedic literature crossed pinning and lateral-only entry techniques are co-gold standards of operative treatment The crossed pinning technique has been shown to be biomechanically superior especially under torsional loading but has a higher incidence of iatrogenic injury to the ulnar nerve All studies comparing these techniques to date have been either biomechanical or retrospective in nature A randomized controlled prospective study comparing these two popular techniques has not been performed
The purpose of this study is to prospectively evaluate the amount of displacement incurred when treating type III supracondylar humerus fractures in children with crossed pinning versus lateral-entry only technique Overall complication rate loss of reduction iatrogenic neurovascular injury and pin tract infection rates between the two cohorts will be evaluated The study population will comprise all patients less than ten years of age presenting to Scottish Rite Hospital during the study period with a type III supracondylar fracture managed by the Childrens Healthcare of Atlanta Orthopedic Group All patients will be randomized to one specific treatment arm based on surgeon preference established at the onset of the study The hypothesis to be tested is that no difference in amount of displacement or overall complication rate is present between these two techniques Radiographic parameters measured pre-operatively immediately post-operatively and four weeks post-operatively will be quantitatively evaluated and compared Chart reviews to determine complications during the treatment period will be made Pre-study power analysis and post-study statistical analysis will be performed
The purpose of this study is to prospectively evaluate the amount of displacement incurred when treating type III supracondylar humerus fractures in children with crossed pinning versus lateral-entry only technique Overall complication rate loss of reduction iatrogenic neurovascular injury and pin tract infection rates between the two cohorts will be evaluated The study population will comprise all patients less than ten years of age presenting to Scottish Rite Hospital during the study period with a type III supracondylar fracture managed by the Childrens Healthcare of Atlanta Orthopedic Group All patients will be randomized to one specific treatment arm based on surgeon preference established at the onset of the study The hypothesis to be tested is that no difference in amount of displacement or overall complication rate is present between these two techniques Radiographic parameters measured pre-operatively immediately post-operatively and four weeks post-operatively will be quantitatively evaluated and compared Chart reviews to determine complications during the treatment period will be made Pre-study power analysis and post-study statistical analysis will be performed
Detailed Description:
Pre-operative consent forms for study participation will be reviewed with all families at the time of the pre-operative visit Screening will be performed at the time of evaluation in the emergency room Patients will be assigned to a particular group based on the surgeon that performs their surgery Each surgeon at the onset of the study will commit to one technique of operative management with the understanding that this technique may be abandoned by the surgeon in any case where it is felt to be inadequate Changing technique will be considered a failure of the technique Data regarding the treatment will be collected from the chart and x-rays at the time of treatment and at follow up visits in the orthopedic office
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None