Radiological and Clinical Outcome After Screw Osteosynthesis of Radial Head Fractures (RadioHead)

March 11, 2020 updated by: University Hospital, Basel, Switzerland
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, 4031
        • Department of Orthopaedics and Traumatology, University Hospital Basel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients undergoing screw osteosynthesis of radial head fractures at Universitätsspital Basel between June 2010 until June 2016

Description

Inclusion Criteria:

  • screw osteosynthesis of radial head fractures

Exclusion Criteria:

  • unable to give consent
  • dementia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in status of bone healing assessed by radiographs
Time Frame: 3 months and 9 months post surgery
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
elbow status assessed by Mayo Elbow Score (MEPS)
Time Frame: 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
single time point, assessment 2 to 7 years after surgery
Patient reported outcome of elbow surgery assessed by Oxford Elbow Score (OES)
Time Frame: 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).
single time point, assessment 2 to 7 years after surgery
Patient reported outcome assessed by Quick Dash
Time Frame: 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.
single time point, assessment 2 to 7 years after surgery
Assessment on employment
Time Frame: 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
single time point, assessment 2 to 7 years after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Investigators

  • Principal Investigator: Daniel Rikli, Prof. Dr., Department of Orthopaedics and Traumatology, University Hospital Basel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 8, 2018

Primary Completion (Actual)

August 6, 2019

Study Completion (Actual)

February 29, 2020

Study Registration Dates

First Submitted

May 6, 2019

First Submitted That Met QC Criteria

May 8, 2019

First Posted (Actual)

May 9, 2019

Study Record Updates

Last Update Posted (Actual)

March 12, 2020

Last Update Submitted That Met QC Criteria

March 11, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-00282; ch19Rikli

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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