Treatment of Medial Epicondyle Fractures in Children and Adolescents

Multi-center Comparative Study of Operative Vs Nonoperative Treatment of Medial Epicondyle Fractures in Children and Adolescents

Cast immobilization in situ versus open reduction and internal fixation of displaced medial epicondyle fractures in children between 7 and 16 years old. A non-inferiority randomized controlled trial.

This is a multicenter, controlled, prospective, randomized non-inferiority study comparing operative treatment to non-operative treatment of over 3 mm dislocated pediatric medial epicondyle fractures without joint incarceration or ulnar nerve dysfunction. A total of 120 patients will be randomized in 1:1 ratio to either operative or non-operative treatment. The study will have a parallel non-randomized patient preference arm. Non-operative treatment will be upper limb immobilization with long arm cast for 4 weeks. Operative treatment will be open reduction and internal fixation (ORIF). Data is collected at baseline and at each follow-up up to 2 years. Quick-DASH is used as primary outcome measure. Secondary outcomes are patient reported pain, differences in range of motion, PedsQL Life inventory questionnaire as well as Mayo elbow preformance score.

Inclusion Criteria:

- Over 2 mm displaced medial epicondyle fracture of humerus on primary AP or lateral X-ray

Exclusion Criteria:

• Ulnar nerve dysfunction
• Pathological fracture
• Open fracture
• Systemic bone disease
• Concomitant fracture or injury of the same upper limb requiring operative intervention
• Other disease preventing participation in full follow-up regime or range of motion exercises