Fracture;Elbow Clinical Trial
Official title:
Comparing Outcomes of Extended Elbow Versus Flexed Elbow Casting for Treatment of Displaced Pediatric Both Bone Forearm Fractures: A Randomized, Controlled Trial
The study design is a prospective, randomized controlled trial comparing extended elbow and flexed elbow casting. This study design will provide the highest quality evidence to investigate our primary hypothesis that extended elbow casting for proximal both bone forearm fractures will result in less loss of fracture alignment. The study population eligible for screening will be patients with open growth plates and both bone forearm fractures.
Guardians of patients will be approached for informed consent as soon as is feasible
following determination of eligibility. Injury characteristics will be obtained from the
enrolling physician and the participant's medical record.
Participants will be prospectively followed at 2, 4, 6, and 24 weeks post casting. All
follow-ups will occur in person in clinic and will consist of radiographs, a clinical
examination and a brief interview. The follow up time points and radiographs are all part of
standard clinical care. The 24 week follow up visit is an optional clinical care visit.
Study duration: 48 months; 40 month enrollment period, 6 month patient follow up and 2 month
data analysis period
Sample size: 88 patients will be consented per arm.
Questionnaires: All questionnaires will take approximately 10 minutes total of the family's
time. And all questionnaires for done solely for research purposes.
Treatment Crossover Cross over from one treatment arm to another should be rare. Cross over
should only occur because of poor cast tolerance or inability to maintain reduction in one
position vs. another. If the extension cast is unsatisfactory to the caregivers/guardians or
patients they may be converted to a flexed elbow cast. These study participants will remain
in the study and be included in an intention-to-treat manner in the final analysis.
To streamline the ease of randomization in a busy department like the ED, patients with an
even medical record number will be enrolled in the extended elbow cast and all odd medical
record number patients will be enrolled in the flexed elbow cast. All CRFs will be
pre-labeled with a study ID. The research staff will then record the study ID on the paper
log that is locked in the ED cabinet. The consents/assents and the eligibility checklist will
be stored in a separate folder in the ED cabinet and picked up weekly by the study
coordinator who will then store the consents/assents and eligibility checklist of enrolled
patients in a locked filing cabinet in their Dept. of Ortho office.
All study visits coincide with regular clinic follow up. The 5 month visits is an optional
clinic visit. The Demographic questionnaire (CRF 001) will be given to them at the first
clinic visit. The family will be asked verbally for responses to CRF 003 regarding cast and
patient experience at every clinic visit. The rest of the CRFs will be completed by study
staff regarding condition of cast (CRF003), CRF002 deals with the alignment of both forearm
bones via the radiograph, and CRF004 is the elbow motion evaluation done by the study staff.
CRF004 is a formal measurement using a goniometer (protractor), whereas the clinical standard
of care is visual assessment without the goniometer.
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