Radiological and Clinical Outcome After Screw Osteosynthesis of Radial Head Fractures

Radial Head Fractures Clinical Trial

— RadioHead  

Official title:

Radiological and Clinical Outcome After Screw Osteosynthesis of Radial Head Fractures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03944590
• Other study ID #: 2018-00282; ch19Rikli
• Status: Completed
• Start date: August 8, 2018
• Est. completion date: February 29, 2020

Study information

• Verified date: March 2020
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 29, 2020
• Est. primary completion date: August 6, 2019
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• screw osteosynthesis of radial head fractures

Exclusion Criteria:

• unable to give consent

• dementia

Related Conditions & MeSH terms

• Fractures, Bone
• Radial Head Fractures
• Radius Fractures

Intervention

Other:
• patient survey
patient survey on clinical outcome after screw osteosynthesis of radial head fractures
• analysis of radiographs
analysis of radiographs on radiological outcome after screw osteosynthesis of radial head fractures

Locations

Country	Name	City	State
Switzerland	Department of Orthopaedics and Traumatology, University Hospital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in status of bone healing assessed by radiographs	Analysis of radiographs with regard to bone healing (cortical bone, dislocation of fracture and dislocation of screws)	3 months and 9 months post surgery
Secondary	elbow status assessed by Mayo Elbow Score (MEPS)	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	single time point, assessment 2 to 7 years after surgery
Secondary	Patient reported outcome of elbow surgery assessed by Oxford Elbow Score (OES)	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).	single time point, assessment 2 to 7 years after surgery
Secondary	Patient reported outcome assessed by Quick Dash	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.	single time point, assessment 2 to 7 years after surgery
Secondary	Assessment on employment	Assessment whether the patient is able to perform the original job activity as before surgery	single time point, assessment 2 to 7 years after surgery