Treatment of Medial Epicondyle Fractures in Children and Adolescents

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Medial Epicondyle Fracture of the Humerus, 7 to16 Year Old Children and Adolecents, More Than 2 mm of Displacement

Intervention / Treatment
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* Procedure: Operative treatment
* Procedure: Long arm cast


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Non-inferiority RCT 1:1 ratio
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: RCT operative<br>Procedure of preference is open reduction and internal fixation (ORIF) with cannulated non-resolvable 4.0mm screw with or without washer. If the fracture fragment is too small or fragmented for screw fixation 1.6mm - 1.8mm Kirshner-wires and/or bone anchor are used. Long arm cast for 4 weeks. | Procedure: Operative treatment<br>* Surgery<br>|
| Active Comparator: RCT Non-operative<br>Non-operative treatment means upper limb immobilization with forearm in neutral pro-supination with a long arm cast for 4 weeks. | Procedure: Long arm cast<br>* cast immobilization<br>|
| Other: Patient preference operative<br>Procedure of preference is open reduction and internal fixation (ORIF) with cannulated non-resolvable 4.0mm screw with or without washer. If the fracture fragment is too small or fragmented for screw fixation 1.6mm - 1.8mm Kirshner-wires and/or bone anchor are used. Long arm cast for 4 weeks. | Procedure: Operative treatment<br>* Surgery<br>|
| Other: Patient preference non-operative<br>Non-operative treatment means upper limb immobilization with forearm in neutral pro-supination with a long arm cast for 4 weeks. | Procedure: Long arm cast<br>* cast immobilization<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 12 months | 
| Cosmetic Visual Analoque Scale (CVAS) | Minimum score 0 maximum 100. Higher value indicates better cosmetic appearance | 12 months | 
| Mayo Elbow Performance Score (MEPS) | Minimum score 0 maximum 100. Higher value indicates better performance. | 12 months | 
| Need for additional procedures (number) | Minimum value 0, no maximum value. Lower value indicates better outcome. | 12 months | 
| Grip strength (kg) with hand held dynamometer (jamar) | compared to standard for age kg/age | 12 months | 
| Sensation and cold intolerance | semmes-weinstein monofilaments scored as normal or abnormal | 12 months |