Radiological and Clinical Outcome After Screw Osteosynthesis of Radial Head Fractures

Completed

• Conditions: Radial Head Fractures

• Registration Number: NCT03944590
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-08
• Study First Submitted: 2019-05-06
• Study First Submitted QC: 2019-05-08
• Study First Posted: 2019-05-09
• Primary Completion: 2019-08-06
• Study Completion: 2020-02-29
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-11
• Last Update Posted: 2020-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• screw osteosynthesis of radial head fractures

Exclusion Criteria

• unable to give consent
• dementia

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in status of bone healing assessed by radiographs	3 months and 9 months post surgery	Analysis of radiographs with regard to bone healing (cortical bone, dislocation of fracture and dislocation of screws)

Secondary Outcome Measures

Name	Time	Method
Assessment on employment	single time point, assessment 2 to 7 years after surgery	Assessment whether the patient is able to perform the original job activity as before surgery
Patient reported outcome of elbow surgery assessed by Oxford Elbow Score (OES)	single time point, assessment 2 to 7 years after surgery	The 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).
elbow status assessed by Mayo Elbow Score (MEPS)	single time point, assessment 2 to 7 years after surgery	A 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 assessed by Quick Dash	single time point, assessment 2 to 7 years after surgery	Quick 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.

Trial Locations

Locations (1)

Department of Orthopaedics and Traumatology, University Hospital Basel; 🇨🇭 Basel, Switzerland