Non-Operative Treatment Compared with Internal Fixation for Displaced Medial Humeral Epicondyle Fractures: A Multicenter Prospective Evaluation
Clinical Trial Information
Trial Contact: Krol, David
Trial Phone: 321.843.5390
IRB No: CHOP IRB 13-010594
Protocol Abbrev: MEMO
Principal Investigator: Benjamin C. Service, MD
Age Group: Pediatric
Secondary Protocol No: MEMO
Treatment: prospective nonrandomized observational study. Consent for participation in the study will be obtained only after the treatment course has been selected. Subjects electing surgical intervention will comprise the operative treatment group, while others electing for non-surgical management will comprise the non-operative treatment group.
Therapies Involved: Procedural
In this prospective observational study, eligible subjects will undergo non-operative or operative treatment for a displaced medial humeral epicondyle fracture. The course of treatment will be decided before enrollment in the study and the treatment decision will be based purely on patient and surgeon preference. Post-treatment outcome assessment will be performed at follow-up clinical visits approximately 1-3 weeks, 3 months, 6 months, 1 year and 2 years after treatment. Information from the medical record will also be abstracted for any interim follow-up visits. Outcomes of treatment will be measured using patient-based outcome scores, including the Quick Disability of the Arm, Shoulder and Hand (QuickDASH) score with the sports module, the Timmerman-Andrews score, the EQ-5D and PROMIS questionnaires, physical examination, radiographic union rate, and complication rates.2,3 The null hypothesis is that there will be no difference between the operative and non-operative groups with respect to surgeon-based and subject-based upper extremity outcome scores.
1. Subjects ages 8-18
2. A medial humeral epicondyle fracture with displacement ≥ 3mm measured on any view of the fracture
3. A clinical decision about treatment for fracture of the medial epicondyle
4. Subject provides informed consent to participate in study