An observational study in Clavicle Fracture and Adolescent, sponsored by Prisma Health-Upstate. Completed at 1 site in United States. Open to participants aged 11 Years to 17 Years. Per ClinicalTrials.gov, last updated 2023-03-28.
Sponsored by Prisma Health-Upstate · Observational
Clavicle fractures in children are common. Typical treatment includes nonoperative treatment with a sling. Operative treatment is usually limited to open, unstable, fractures with either epidermal risks or neurovascular compromise. Orthopaedic literature has many studies that report the need for additional research for this prevalent fracture. This is an observational study evaluating the functional and patient reported outcomes of displaced clavicle fractures in adolescents. The results from this study will help the orthopedist understand the expected outcomes for a given pediatric patient with a clavicle fracture.
11-17 years old with displaced fractures of the middle third of the clavicle
Exclusion Criteria:
Adolescents (11 to 17 years old) with displaced clavicle fractures will be enrolled in this study.
Other: Clavicle fracture injury- observation
The study is an observational study with assessments at 1 month, 3 months, 6 months and 1 year following injury. Assessments include range of motion, strength, patient reported outcomes and radiographic healing
Range of motion
Range of motion measured by goniometer
Time frame: at 1 year post injury
Radiographic healing
Radiographic evidence of healing on 3 of 4 cortices
Time frame: at 1 year post injury
QuickDash
QuickDash Outcome Measure- measuring patient reported disability of arm, shoulder and hand
Time frame: at 3 months, 6 months and 12 months
PODCI
Adolescent Pediatric Outcomes Data Collection Instrument - measuring patient reported outcomes in a pediatric population
Time frame: at 3 months, 6 months and 12 months
Strength Measurements
Upper extremity strength measurements, measured by dynamometer (forward flexion, abduction, and external rotation
Time frame: 6 months and 12 months
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — There are no plans to share IPD
This study is completed, as verified in Mar 2023. 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.
Prisma Health-Upstate