Clinical trial NCT04531085: 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
Overall status: COMPLETED
Phase: NA
Conditions: Medial Epicondyle Fracture of the Humerus
7 To16 Year Old Children and Adolecents
More Than 2 Mm of Displacement
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2020-08-28
Enrollment: 72
Sex: ALL
Minimum age (years): 7
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Non-inferiority RCT 1:1 ratio
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Quick Disabilities of the Arm, Shoulder and Hand score questionnaire(QuickDASH)
timeFrame: 12 months
Secondary outcomes:
measure: Range of Motion (ROM) degrees difference of the elbow as compared to uninjured arm
timeFrame: 12 months
measure: Measurement Model for the Pediatric Quality of Life Inventory questionnaire (PedsQL)
timeFrame: 12 months
measure: Measurement Model for the Pediatric Quality of Life Inventory Pediatric Pain Questionaire (PEDS QL PPQ)
timeFrame: 12 months
measure: Cosmetic Visual Analoque Scale (CVAS)
timeFrame: 12 months
measure: Mayo Elbow Performance Score (MEPS)
timeFrame: 12 months
measure: Need for additional procedures (number)
timeFrame: 12 months
measure: Grip strength (kg) with hand held dynamometer (jamar)
timeFrame: 12 months
measure: Sensation and cold intolerance
timeFrame: 12 months
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: HUS New Childrens Hospital
city: Kuopio
country: Finland
facility: Kuopio University Hospital
city: Oulu
country: Finland
facility: Oulu University Hospital
city: Turku
country: Finland
facility: Turku University Hospital
Study officials:
affiliation: Helsinki University Hospital, New Childrens Hospital
name: Petra Grahn, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.