Treatment of Medial Epicondyle Fractures in Children and Adolescents

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-30

Study Completion Date

2024-08-30

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.

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Non-inferiority RCT 1:1 ratio

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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RCT operative

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.

Group Type ACTIVE_COMPARATOR

Operative treatment

Intervention Type PROCEDURE

Surgery

RCT Non-operative

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

Group Type ACTIVE_COMPARATOR

Long arm cast

Intervention Type PROCEDURE

cast immobilization

Patient preference operative

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.

Group Type OTHER

Operative treatment

Intervention Type PROCEDURE

Surgery

Patient preference non-operative

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

Group Type OTHER

Long arm cast

Intervention Type PROCEDURE

cast immobilization

Interventions

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Operative treatment

Surgery

Intervention Type PROCEDURE

Long arm cast

cast immobilization

Intervention Type PROCEDURE

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

Minimum Eligible Age

7 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No