Medial Epicondyle Fracture of the Humerus, 7 To16 Year Old Children and Adolecents, More Than 2 Mm of Displacement
Conditions
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.
Interventions
PROCEDUREOperative treatment
Surgery
PROCEDURELong arm cast
cast immobilization
Sponsors
Helsinki University Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
Non-inferiority RCT 1:1 ratio
Eligibility
Sex/Gender
ALL
Age
7 Years to 16 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quick Disabilities of the Arm, Shoulder and Hand score questionnaire(QuickDASH) | 12 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Measurement Model for the Pediatric Quality of Life Inventory questionnaire (PedsQL) | 12 months | 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) | 12 months | Minimum score 0 maximum 10. Higher value indicates higher pain intensity. |
| Cosmetic Visual Analoque Scale (CVAS) | 12 months | Minimum score 0 maximum 100. Higher value indicates better cosmetic appearance |
| Range of Motion (ROM) degrees difference of the elbow as compared to uninjured arm | 12 months | Difference in active ROM in comparison to uninjured arm. Maximum value is 160 degrees minimum 0. Lower value indicates better outcome. |
| Need for additional procedures (number) | 12 months | Minimum value 0, no maximum value. Lower value indicates better outcome. |
| Grip strength (kg) with hand held dynamometer (jamar) | 12 months | compared to standard for age kg/age |
| Sensation and cold intolerance | 12 months | semmes-weinstein monofilaments scored as normal or abnormal |
| Mayo Elbow Performance Score (MEPS) | 12 months | Minimum score 0 maximum 100. Higher value indicates better performance. |
Countries
Finland
Outcome results
None listed