An interventional study of Operative treatment and Long arm cast in Medial Epicondyle Fracture of the Humerus, 7 To16 Year Old Children and Adolecents and More Than 2 Mm of Displacement, sponsored by Helsinki University Central Hospital. Completed at 4 sites in Finland. Open to participants aged 7 Years to 16 Years. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Helsinki University Central Hospital · Not applicable, Interventional, and Treatment
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.
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.
Helsinki University Central Hospital is the lead sponsor of 311 studies on the registry; 61 are open to participants now.
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- Over 2 mm displaced medial epicondyle fracture of humerus on primary AP or lateral X-ray
Exclusion Criteria:
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
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
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
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
Surgery
cast immobilization
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.
Time frame: 12 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months
Cosmetic Visual Analoque Scale (CVAS)
Minimum score 0 maximum 100. Higher value indicates better cosmetic appearance
Time frame: 12 months
Mayo Elbow Performance Score (MEPS)
Minimum score 0 maximum 100. Higher value indicates better performance.
Time frame: 12 months
Need for additional procedures (number)
Minimum value 0, no maximum value. Lower value indicates better outcome.
Time frame: 12 months
Grip strength (kg) with hand held dynamometer (jamar)
compared to standard for age kg/age
Time frame: 12 months
Sensation and cold intolerance
semmes-weinstein monofilaments scored as normal or abnormal
Time frame: 12 months
Plan to share: Yes — Data will be available upon request. Any requests should be sent to the principal investigator.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: upon request. Most of the above published in BMJ Open.
Access criteria: Please see BMJ open
Data sharing details ↗ · bmjopen.bmj.com
Ran from Aug 2019 to primary completion in Aug 2024, 60 months.
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