NCT04531085

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Helsinki University Central Hospital · Academic / Other
• Sex: All
• Age: 7 Years – 16 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Medial Epicondyle Fracture of the Humerus
• 7 To16 Year Old Children and Adolecents
• More Than 2 Mm of Displacement

Interventions

Type	Name	Description
PROCEDURE	Operative treatment	Surgery
PROCEDURE	Long arm cast	cast immobilization

Timeline

• Start date: 2019-08-30
• Primary completion: 2024-08-30
• Completion: 2024-08-30
• First posted: 2020-08-28
• Last updated: 2024-09-19

Locations

4 sites across 1 country: Finland