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Completed

NCT Number: NCT03944590

Radiological and Clinical Outcome After Screw Osteosynthesis of Radial Head Fractures

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Orthopaedics and Traumatology, University Hospital Basel

Basel, 4031, Switzerland

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • screw osteosynthesis of radial head fractures

Exclusion criteria

  • unable to give consent
  • dementia

Treatment and study plan

patient survey

Other

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

analysis of radiographs

Other

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Acronym: RadioHead

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
May 9, 2019
Registry last updated
Mar 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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