Treatment of Medial Epicondyle Fractures in Children and Adolescents

Helsinki University Central Hospital (HUCH)

Status: Completed

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

Treatments: Procedure: Long arm cast; Procedure: Operative treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT04531085

HUS/1443/2019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 patients

Sex: All

Ages: 7 to 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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72 participants in 4 patient groups

RCT operative

Active Comparator group

Description:

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.

Treatment:

Procedure: Operative treatment

RCT Non-operative

Active Comparator group

Description:

Non-operative treatment means upper limb immobilization with forearm in neutral pro-supination with a long arm cast for 4 weeks.

Treatment:

Procedure: Long arm cast

Patient preference operative

Other group

Description:

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.

Treatment:

Procedure: Operative treatment

Patient preference non-operative

Other group

Description:

Non-operative treatment means upper limb immobilization with forearm in neutral pro-supination with a long arm cast for 4 weeks.

Treatment:

Procedure: Long arm cast