Treatment of Medial Epicondyle Fractures in Children and Adolescents

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

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.

Study Overview

• Status: Recruiting
• Conditions: Medial Epicondyle Fracture of the Humerus; 7 to16 Year Old Children and Adolecents; More Than 2 mm of Displacement
• Intervention / Treatment: Procedure: Operative treatment; Procedure: Long arm cast

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 Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Petra Grahn, MD; Phone Number: +35894711; Email: petra.grahn@hus.fi

Study Locations

• Finland
  • Helsinki, Finland, 00029HUS
    • Recruiting
    • HUS New Childrens Hospital
    • Contact: Petra Grahn, MD; Phone Number: +358 9 4711
    • Contact: Matti Ahonen, MD; Phone Number: + 358 9 4711
  • Kuopio, Finland
    • Recruiting
    • Kuopio University Hospital
    • Contact: Yrjänä Nietosvaara, MD
    • Contact: Jenny Jalkanen, MD
  • Oulu, Finland
    • Not yet recruiting
    • Oulu University Hospital
    • Contact: Juha-Jaakko Sinikumpu, MD
  • Tampere, Finland
    • Recruiting
    • Tampere University Hospital
    • Contact: Anne Salonen, MD
  • Turku, Finland
    • Recruiting
    • Turku University Hospital
    • Contact: Markus Lastikka, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: Operative treatment; Surgery
Active Comparator: RCT Non-operative; 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; cast immobilization
Other: 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.	Procedure: Operative treatment; Surgery
Other: 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.	Procedure: Long arm cast; cast immobilization

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Helsinki University Central Hospital
• Investigators: Principal Investigator: Petra Grahn, MD, Helsinki University Hospital, New Childrens Hospital

Publications and helpful links

General Publications

• Hamalainen T, Ahonen M, Helenius I, Jalkanen J, Lastikka M, Nietosvaara Y, Salonen A, Sinikumpu JJ, Grahn P. Cast immobilisation in situ versus open reduction and internal fixation of displaced medial epicondyle fractures in children between 7 and 16 years old. A study protocol for a randomised controlled trial. BMJ Open. 2021 May 3;11(5):e044627. doi: 10.1136/bmjopen-2020-044627.

Helpful Links

• Protocol publication

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2019
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: August 22, 2020
• First Submitted That Met QC Criteria: August 26, 2020
• First Posted (Actual): August 28, 2020

Study Record Updates

• Last Update Posted (Actual): March 24, 2022
• Last Update Submitted That Met QC Criteria: March 21, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Fractures, Bone; Humeral Fractures
• Other Study ID Numbers: HUS/1443/2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be available upon request. Any requests should be sent to the principal investigator.
• IPD Sharing Time Frame: upon request. Most of the above published in BMJ Open.
• IPD Sharing Access Criteria: Please see BMJ open
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No