Treatment of Medial Epicondyle Fractures in Children and Adolescents

NCT04531085 | Completed DMC

• 1 other identifier: HUS/1443/2019
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 4

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Range of Motion (ROM) degrees difference of the elbow as compared to uninjured arm

  12 months

• Measurement Model for the Pediatric Quality of Life Inventory questionnaire (PedsQL)

  12 months

• Measurement Model for the Pediatric Quality of Life Inventory Pediatric Pain Questionaire (PEDS QL PPQ)

  12 months

• Cosmetic Visual Analoque Scale (CVAS)

  12 months

• Mayo Elbow Performance Score (MEPS)

  12 months

Study Arms (4)

RCT operative

ACTIVE COMPARATOR

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

RCT Non-operative

ACTIVE COMPARATOR

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

Patient preference operative

OTHER

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

Patient preference non-operative

OTHER

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

Interventions

Operative treatment PROCEDURE

Surgery

Patient preference operative; RCT operative

Long arm cast PROCEDURE

cast immobilization

Patient preference non-operative; RCT Non-operative

Eligibility Criteria

• Age: 7 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \- Over 2 mm displaced medial epicondyle fracture of humerus on primary AP or lateral X-ray

You may not qualify if:

• 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

Sponsors & Collaborators

• Helsinki University Central Hospital: lead

Study Sites (4)

HUS New Childrens Hospital

Helsinki, 00029HUS, Finland

Location

Kuopio University Hospital

Kuopio, Finland

Location

Oulu University Hospital

Oulu, Finland

Location

Turku University Hospital

Turku, Finland

Location

Related Publications (2)

• Grahn P, Helenius I, Hamalainen T, Kivisaari R, Nietosvaara Y, Sinikumpu JJ, Jalkanen J, Loyttyniemi E, Ahonen M; Finnish Pediatric Orthopedic Study Group Investigators. Casting vs Surgical Treatment of Children With Medial Epicondyle Fractures: A Randomized Clinical Trial. JAMA Netw Open. 2025 May 1;8(5):e258479. doi: 10.1001/jamanetworkopen.2025.8479.

  PMID: 40327343 DERIVED

• 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.

  PMID: 33941629 DERIVED

Related Links

• Protocol publication

Study Officials

• Petra Grahn, MD

  Helsinki University Hospital, New Childrens Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Hand Surgeon

Model Details: Non-inferiority RCT 1:1 ratio

Study Record Dates

• First Submitted: August 22, 2020
• First Posted: August 28, 2020
• Study Start: August 30, 2019
• Primary Completion: August 30, 2024
• Study Completion: August 30, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: upon request. Most of the above published in BMJ Open.
• Access Criteria: Please see BMJ open

Locations

FI (4)