Treatment of Medial Epicondyle Fractures in Children and Adolescents

Not Applicable

Recruiting

• Conditions: Medial Epicondyle Fracture of the Humerus; 7 To16 Year Old Children and Adolecents; More Than 2 Mm of Displacement
• Interventions: Procedure: Long arm cast; Procedure: Operative treatment

• Registration Number: NCT04531085
• Lead Sponsor: Helsinki University Central Hospital

Brief 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.

Study Timeline

• Study Start: 2019-08-30
• Study First Submitted: 2020-08-22
• Study First Submitted QC: 2020-08-26
• Study First Posted: 2020-08-28
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-21
• Last Update Posted: 2022-03-24
• Primary Completion: 2023-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patient preference non-operative	Long arm cast	Non-operative treatment means upper limb immobilization with forearm in neutral pro-supination with a long arm cast for 4 weeks.
RCT operative	Operative treatment	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.
RCT Non-operative	Long arm cast	Non-operative treatment means upper limb immobilization with forearm in neutral pro-supination with a long arm cast for 4 weeks.
Patient preference operative	Operative treatment	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.

Primary Outcome Measures

Name	Time	Method
Quick Disabilities of the Arm, Shoulder and Hand score questionnaire(QuickDASH)	12 months	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.

Secondary Outcome Measures

Name	Time	Method
Cosmetic Visual Analoque Scale (CVAS)	12 months	Minimum score 0 maximum 100. Higher value indicates better cosmetic appearance
Range of Motion (ROM) degrees difference of the elbow as compared to uninjured arm	12 months	Difference in active ROM in comparison to uninjured arm. Maximum value is 160 degrees minimum 0. Lower value indicates better outcome.
Measurement Model for the Pediatric Quality of Life Inventory questionnaire (PedsQL)	12 months	Minimum score is 0 and maximum 100. Higher score indicates better health related quality of life.
Mayo Elbow Performance Score (MEPS)	12 months	Minimum score 0 maximum 100. Higher value indicates better performance.
Measurement Model for the Pediatric Quality of Life Inventory Pediatric Pain Questionaire (PEDS QL PPQ)	12 months	Minimum score 0 maximum 10. Higher value indicates higher pain intensity.
Need for additional procedures (number)	12 months	Minimum value 0, no maximum value. Lower value indicates better outcome.
Grip strength (kg) with hand held dynamometer (jamar)	12 months	compared to standard for age kg/age
Sensation and cold intolerance	12 months	semmes-weinstein monofilaments scored as normal or abnormal

Trial Locations

Locations (4)

HUS New Childrens Hospital; 🇫🇮 Helsinki, Finland

Kuopio University Hospital; 🇫🇮 Kuopio, Finland

Oulu University Hospital; 🇫🇮 Oulu, Finland

Turku University Hospital; 🇫🇮 Turku, Finland