Treatment of Medial Epicondyle Fractures in Children and Adolescents

Helsinki University Central Hospital72 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

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

Interventions

Operative treatmentPROCEDURE

Surgery

Long arm castPROCEDURE

cast immobilization

Eligibility

Sex: ALLMin age: 7 YearsMax age: 16 Years

Medical Language ↔ Plain English

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

Locations (4)

HUS New Childrens Hospital

Helsinki, Finland

Kuopio University Hospital

Kuopio, Finland

Oulu University Hospital

Oulu, Finland

Turku University Hospital

Turku, Finland

Outcomes

Primary Outcomes

Quick Disabilities of the Arm, Shoulder and Hand score questionnaire(QuickDASH)

Minimum value is 0 and maximum 100. Higher value indicates worse function. Statistically significant difference in QuickDASH score is 6.8 (18) at 12 months FU.

Time frame: 12 months

Secondary Outcomes

Range of Motion (ROM) degrees difference of the elbow as compared to uninjured arm

Difference in active ROM in comparison to uninjured arm. Maximum value is 160 degrees minimum 0. Lower value indicates better outcome.

Time frame: 12 months

Measurement Model for the Pediatric Quality of Life Inventory questionnaire (PedsQL)

Minimum score is 0 and maximum 100. Higher score indicates better health related quality of life.

Time frame: 12 months

Measurement Model for the Pediatric Quality of Life Inventory Pediatric Pain Questionaire (PEDS QL PPQ)

Minimum score 0 maximum 10. Higher value indicates higher pain intensity.

Time frame: 12 months

Cosmetic Visual Analoque Scale (CVAS)

Minimum score 0 maximum 100. Higher value indicates better cosmetic appearance

Time frame: 12 months

Mayo Elbow Performance Score (MEPS)

Minimum score 0 maximum 100. Higher value indicates better performance.

Time frame: 12 months

Need for additional procedures (number)

Minimum value 0, no maximum value. Lower value indicates better outcome.

Time frame: 12 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.