search
Back to results

Treatment of Medial Epicondyle Fractures in Children and Adolescents

Primary Purpose

Medial Epicondyle Fracture of the Humerus, 7 to16 Year Old Children and Adolecents, More Than 2 mm of Displacement

Status
Recruiting
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Operative treatment
Long arm cast
Sponsored by
Helsinki University Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Medial Epicondyle Fracture of the Humerus

Eligibility Criteria

7 Years - 16 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • HUS New Childrens HospitalRecruiting
  • Kuopio University HospitalRecruiting
  • Oulu University Hospital
  • Tampere University HospitalRecruiting
  • Turku University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Other

Other

Arm Label

RCT operative

RCT Non-operative

Patient preference operative

Patient preference non-operative

Arm 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.

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

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
Cosmetic Visual Analoque Scale (CVAS)
Minimum score 0 maximum 100. Higher value indicates better cosmetic appearance
Mayo Elbow Performance Score (MEPS)
Minimum score 0 maximum 100. Higher value indicates better performance.
Need for additional procedures (number)
Minimum value 0, no maximum value. Lower value indicates better outcome.
Grip strength (kg) with hand held dynamometer (jamar)
compared to standard for age kg/age
Sensation and cold intolerance
semmes-weinstein monofilaments scored as normal or abnormal

Full Information

First Posted
August 22, 2020
Last Updated
March 21, 2022
Sponsor
Helsinki University Central Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT04531085
Brief Title
Treatment of Medial Epicondyle Fractures in Children and Adolescents
Official Title
Multi-center Comparative Study of Operative vs Nonoperative Treatment of Medial Epicondyle Fractures in Children and Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 30, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helsinki University Central Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Medial Epicondyle Fracture of the Humerus, 7 to16 Year Old Children and Adolecents, More Than 2 mm of Displacement

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Non-inferiority RCT 1:1 ratio
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RCT operative
Arm Type
Active Comparator
Arm 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.
Arm Title
RCT Non-operative
Arm Type
Active Comparator
Arm Description
Non-operative treatment means upper limb immobilization with forearm in neutral pro-supination with a long arm cast for 4 weeks.
Arm Title
Patient preference operative
Arm Type
Other
Arm 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.
Arm Title
Patient preference non-operative
Arm Type
Other
Arm Description
Non-operative treatment means upper limb immobilization with forearm in neutral pro-supination with a long arm cast for 4 weeks.
Intervention Type
Procedure
Intervention Name(s)
Operative treatment
Intervention Description
Surgery
Intervention Type
Procedure
Intervention Name(s)
Long arm cast
Intervention Description
cast immobilization
Primary Outcome Measure Information:
Title
Quick Disabilities of the Arm, Shoulder and Hand score questionnaire(QuickDASH)
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Range of Motion (ROM) degrees difference of the elbow as compared to uninjured arm
Description
Difference in active ROM in comparison to uninjured arm. Maximum value is 160 degrees minimum 0. Lower value indicates better outcome.
Time Frame
12 months
Title
Measurement Model for the Pediatric Quality of Life Inventory questionnaire (PedsQL)
Description
Minimum score is 0 and maximum 100. Higher score indicates better health related quality of life.
Time Frame
12 months
Title
Measurement Model for the Pediatric Quality of Life Inventory Pediatric Pain Questionaire (PEDS QL PPQ)
Description
Minimum score 0 maximum 10. Higher value indicates higher pain intensity.
Time Frame
12 months
Title
Cosmetic Visual Analoque Scale (CVAS)
Description
Minimum score 0 maximum 100. Higher value indicates better cosmetic appearance
Time Frame
12 months
Title
Mayo Elbow Performance Score (MEPS)
Description
Minimum score 0 maximum 100. Higher value indicates better performance.
Time Frame
12 months
Title
Need for additional procedures (number)
Description
Minimum value 0, no maximum value. Lower value indicates better outcome.
Time Frame
12 months
Title
Grip strength (kg) with hand held dynamometer (jamar)
Description
compared to standard for age kg/age
Time Frame
12 months
Title
Sensation and cold intolerance
Description
semmes-weinstein monofilaments scored as normal or abnormal
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Petra Grahn, MD
Phone
+35894711
Email
petra.grahn@hus.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Petra Grahn, MD
Organizational Affiliation
Helsinki University Hospital, New Childrens Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
HUS New Childrens Hospital
City
Helsinki
ZIP/Postal Code
00029HUS
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Petra Grahn, MD
Phone
+358 9 4711
First Name & Middle Initial & Last Name & Degree
Matti Ahonen, MD
Phone
+ 358 9 4711
Facility Name
Kuopio University Hospital
City
Kuopio
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yrjänä Nietosvaara, MD
First Name & Middle Initial & Last Name & Degree
Jenny Jalkanen, MD
Facility Name
Oulu University Hospital
City
Oulu
Country
Finland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juha-Jaakko Sinikumpu, MD
Facility Name
Tampere University Hospital
City
Tampere
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Salonen, MD
Facility Name
Turku University Hospital
City
Turku
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Markus Lastikka, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://bmjopen.bmj.com/content/11/5/e044627
Citations:
PubMed Identifier
33941629
Citation
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.
Results Reference
derived
Links:
URL
https://bmjopen.bmj.com/content/11/5/e044627
Description
Protocol publication

Learn more about this trial

Treatment of Medial Epicondyle Fractures in Children and Adolescents

We'll reach out to this number within 24 hrs