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Radiological and Clinical Outcome After Screw Osteosynthesis of Radial Head Fractures

Radiological and Clinical Outcome After Screw Osteosynthesis of Radial Head Fractures

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03944590
Acronym
RadioHead
Enrollment
40
Registered
2019-05-09
Start date
2018-08-08
Completion date
2020-02-29
Last updated
2020-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Radial Head Fractures

Keywords

screw osteosynthesis, rupture of the interosseous membrane, collateral ligaments

Brief summary

This cohort study investigates radiological and clinical outcome after screw osteosynthesis of radial head fractures with associated injuries (such as rupture of the interosseous membrane and collateral ligaments). Interpretation of radiographs 3 and 9 months post- surgery and patient surveys will be analyzed.

Interventions

patient survey on clinical outcome after screw osteosynthesis of radial head fractures

OTHERanalysis of radiographs

analysis of radiographs on radiological outcome after screw osteosynthesis of radial head fractures

Sponsors

University Hospital, Basel, Switzerland
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* screw osteosynthesis of radial head fractures

Exclusion criteria

* unable to give consent * dementia

Design outcomes

Primary

MeasureTime frameDescription
Change in status of bone healing assessed by radiographs3 months and 9 months post surgeryAnalysis of radiographs with regard to bone healing (cortical bone, dislocation of fracture and dislocation of screws)

Secondary

MeasureTime frameDescription
elbow status assessed by Mayo Elbow Score (MEPS)single time point, assessment 2 to 7 years after surgeryA clinician-completed scoring system used to evaluate the level of disability in the elbow, assessing pain, functional status (based on number tasks performed), range of motion and joint stability. Clinical information is rated based on a 100 points scale: \<60 - poor 60-74 - fair 75-89 - good 90-100 - excellent
Patient reported outcome of elbow surgery assessed by Oxford Elbow Score (OES)single time point, assessment 2 to 7 years after surgeryThe Oxford Elbow Score has 12 items (questions) with 5 response options each. Each item response is scored 0 to 4, with 0 representing greater severity. Underlying the 12 items are 3 domains (sub-scales): Elbow pain, Elbow function and Social-psychological domain. Scores for each domain are calculated as the sum of each individual item score within that domain, which is then converted to a metric of 0 - 100 (lower score representing greater severity).
Patient reported outcome assessed by Quick Dashsingle time point, assessment 2 to 7 years after surgeryQuick Dash is a questionnaire that measures an individual's ability to complete tasks, absorb forces, and severity of symptoms. The QuickDASH tool uses a 5-point Likert scale from which the patient can select an appropriate number corresponding to his/her severity level/ function level. Scoring ranges from 1 = no difficulty to 5 = unable to do. A higher score indicates a greater level of disability and severity.
Assessment on employmentsingle time point, assessment 2 to 7 years after surgeryAssessment whether the patient is able to perform the original job activity as before surgery

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026