Operative
Procedureopen reduction : fixation by k-wires or screws
NCT Number: NCT06454929
Compare the outcome of the operative and non-operative treatment; for fractures of the medial epicondyle of humerus in children as regards union, alignment and complications.
Trial opening soon.
Get Notified1 year–16 year
All sexes
Interventional
Not applicable
On the distal humerus, posteromedially, is where the medial epicondyle apophysis is situated. It serves as the starting point for the flexor-pronator muscle and the ulnar collateral ligament. 12-20% of pediatric elbow fractures have been reported to be caused by fractures of the medial humeral epicondyle. Thirty to fifty percent of these fractures result in elbow dislocation, and eighteen to twenty percent of the fracture fragments become lodged in the elbow joint. The medial epicondyle fractures typically happen between the ages of 9 and 14 due to the insufficient ossification of the bone, which makes it more prone to failure early than the stronger soft-tissue attachments.
Optimal treatment for pediatric medial epicondyle fractures continues to be a topic of debate.
In the face of technical advancements, evolving surgical indications, and societal pressures, there is little concrete data demonstrating the superiority of either operative or non-operative treatment.
When a child's medial humeral epicondyle fracture is minimally displaced (less than 2 mm), non-operative therapy is recommended. The PedsQL Pediatric discomfort Questionnaire revealed that children who received non-operative treatment experienced reduced discomfort (3 vs. 15, p = 0.01) and had superior cosmetic results. There is a great deal of disagreement about how to treat displaced fractures (3-15 mm), with some surgeons supporting internal fixation as the non-union rate drops significantly. For upper-extremity athletes who need elbow stability to play their sport, surgery is also advised. Furthermore, it has been proposed that there are no statistically significant variations in outcomes between surgical and non-operative groups.
Fractures of the medial humeral epicondyle in children heal well with 3-4 weeks' immobilization. There is no common consensus in treatment of closed medial epicondyle fractures with >2 mm displacement (without incarceration of the fragment inside the joint or ulnar nerve dysfunction) that Open reduction and screw fixation improve outcome.
The purpose of our study is to compare the treatment outcomes and complications between operatively and non-operatively treated displaced medial epicondyle fractures. We aim to improve our understanding of the outcomes of these fractures to make treatment recommendations. We hypothesise that there is no difference in treatment outcomes between non-operative and operative treatment.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
open reduction : fixation by k-wires or screws
close reduction : by cast Immobilization
Time frame: baseline
QuickDASH uses 11 items to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb.
Contact information is provided by the study sponsor or research team.
ahmed ezzat M eltaweel, Physician
CONTACT
01068950894 ext. +20
mohamed K hassan, prof
CONTACT
01015636726 ext. +20
Assiut University
Other
Comparison Between Operative And Non-operative Treatment of Displaced Medial Epicondyle Fractures In Children
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07536581
Adolescent, Arm Injuries
København NV, Denmark
View Trial DetailsNCT06504992
Fractures, Bone, Fractures, Open
Winnipeg, Manitoba, Canada
View Trial DetailsNCT06603545
Accidental Falls, Behavior
View Trial DetailsNCT06510595
Fractures, Bone, Wounds and Injuries
View Trial Details