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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

Radiological and Clinical Outcome After Screw Osteosynthesis of Radial Head Fractures

Clinicaltrials.gov identifier NCT03944590

Recruitment Status Completed

First Posted May 9, 2019

Last update posted March 12, 2020

Study Description

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.

  • Condition or Disease:Radial Head Fractures
  • Intervention/Treatment: Other: patient survey
    Other: analysis of radiographs
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Observational
  • Actual Enrollment: 40 participants
  • Observational Model: Cohort
  • Time Perspective: Prospective
  • Official Title: Radiological and Clinical Outcome After Screw Osteosynthesis of Radial Head Fractures
  • Actual Study Start Date: August 2018
  • Actual Primary Completion Date: August 2019
  • Actual Study Completion Date: February 2020
Outcome Measures
  • Primary Outcome Measures: 1. 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)
  • Secondary Outcome Measures: 1. 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
  • 2. 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).
  • 3. 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.
  • 4. 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
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers:
  • Sampling Method: Probability Sample
  • Study Population: patients undergoing screw osteosynthesis of radial head fractures at Universitätsspital Basel between June 2010 until June 2016
Criteria

Inclusion Criteria:

- screw osteosynthesis of radial head fractures

Exclusion Criteria:

- unable to give consent

- dementia

Contacts and Locations
Contacts
Locations

Switzerland
Department of Orthopaedics and Traumatology, University Hospital Basel
Basel

Sponsors and Collaborators

University Hospital, Basel, Switzerland

Investigators

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

More Information
  • Responsible Party: University Hospital, Basel, Switzerland
  • ClinicalTrials.gov Identifier: NCT03944590 History of Changes
  • Other Study ID Numbers: 2018-00282; ch19Rikli
  • First Posted: May 9, 2019 Key Record Dates
  • Last Update Posted: March 12, 2020
  • Last Verified: March 2020
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by University Hospital, Basel, Switzerland: screw osteosynthesis
    rupture of the interosseous membrane
    collateral ligaments
  • Additional relevant MeSH terms: Fractures, Bone Radius Fractures