An interventional study of elbow cast and Removable elbow brace in Radial Fracture, sponsored by Peking University People's Hospital. Status unknown at 1 site in China. Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2017-12-04.
Sponsored by Peking University People's Hospital · Not applicable, Interventional, and Treatment
Commare the pain and function of Brace Versus Casting in Pediatric Radial Head Fractures after 1 month
Radial Head Fractures are common injury in children. In this study, healthy children with Mason type I or II radial head fractures are planned to be included.
Outcome Measures: The primary outcome measure will be an assessment of functional daily activities as measured by the MAYO score at four weeks post injury. Secondary outcomes will include an assessment of pain scores using VAS.
Sample Size and Analysis: Assuming a standard deviation of 10%, alpha = 0.05, beta = 0.2 and 10% dropout rate yields a sample size of 150 patients. Secondary analyses will include Fisher's Exact test to compare proportions of children with full range of motion of the injured ankle at four weeks and with full baseline activity level at four months, and the area under the curve of a pain-time profile curve will be compared using a Student's t-test.
62 studies on the registry are indexed under Radius Fractures; 6 are open to participants now.
This study's planned enrollment of 150 is above the median of 60 across 48 interventional studies indexed under Radius Fractures.
Browse Radius Fractures studies →Peking University People's Hospital is the lead sponsor of 609 studies on the registry; 247 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
5 to 18 years of age with one of the following fracture Undisplaced Maoson types I and II fractures of the radial head
Exclusion Criteria:
The diagnosis of elbow sprain or contusion; they occur primarily in adolescents with closed epiphyseal plates.
All open fractures which require surgical debridement. All children at risk for pathological fractures such as those with congenital or acquired generalized bony disease.
Congenital anomalies of the elbow. Patients with coagulopathies. Multisystem trauma and multiple fractures of the same or opposite limb. Patients cognitively and developmentally delayed with inability to express pain and/or difficult assessment of baseline activity level.
Injuries greater than 72 hours old. Past history of surgery or closed reduction of the same elbow within the last 6 months or ankle trauma of the same ankle within 3 months.
Device: Elbow cast
Device: elbow cast
Device: Removable elbow brace
Device: Removable elbow brace
elbow cast
Removable elbow brace
Mayo score
Functional outcome as measured by the Mayo score at 4 weeks from the time of the initial injury
Time frame: 1 month
pain
VAS score
Time frame: 1 month
Start is estimated for Feb 2018; primary completion for Feb 2019, 12 months later.
Of 14 interventional studies with no phase under Radius Fractures, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 29. This study's planned 12 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Peking University People's Hospital →