Radial Head FracturesRadioHeadNCT03944590
Radiological and Clinical Outcome After Screw Osteosynthesis of Radial Head Fractures
An observational study of Radial Head Fractures, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radial Head Fractures
- What is being tested?
- patient survey and analysis of radiographs
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- 8 Aug 2018to 29 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: patients undergoing screw osteosynthesis of radial head fractures at Universitätsspital Basel between June 2010 until June 2016
Who may be able to join
- screw osteosynthesis of radial head fractures
Who cannot join
- unable to give consent
- dementia
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Orthopaedics and Traumatology, University Hospital Basel
Basel, 4031
About this study
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.
- Conditions
- Radial Head Fractures
- Being tested
- patient survey, analysis of radiographs
- Keywords
- screw osteosynthesis, rupture of the interosseous membrane, collateral ligaments
- Medical subject headings
- Radial Head and Neck Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patient surveyOther
patient survey on clinical outcome after screw osteosynthesis of radial head fractures
analysis of radiographsOther
analysis of radiographs on radiological outcome after screw osteosynthesis of radial head fractures
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 3 months and 9 months post surgery
Secondary outcomes (4)
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
Measured: single time point, assessment 2 to 7 years after surgery
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).
Measured: single time point, assessment 2 to 7 years after surgery
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.
Measured: single time point, assessment 2 to 7 years after surgery
Assessment on employment
Assessment whether the patient is able to perform the original job activity as before surgery
Measured: single time point, assessment 2 to 7 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2019
- Study start8 Aug 2018
- Primary completion6 Aug 2019
- Study completion29 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radial Head FracturesStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Rikli, Prof. Dr., Principal investigator, Department of Orthopaedics and Traumatology, University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03944590
- Sponsor's protocol ID
- 2018-00282; ch19Rikli
- Other IDs
- 2018
- Acronym
- RadioHead
- Status last verified
- Mar 2020
- First submitted
- 6 May 2019
- Last updated
- 12 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiological and Clinical Outcome After Screw Osteosynthesis of Radial Head Fractures
- ClinicalTrials.gov ID
- NCT03944590
- Acronym / sponsor ID
- RadioHead / 2018-00282; ch19Rikli
- Conditions
- Radial Head Fractures
- Keywords
- screw osteosynthesis, rupture of the interosseous membrane, collateral ligaments
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 8 Aug 2018 (actual)
- Primary completion
- 6 Aug 2019 (actual)
- Study completion
- 29 Feb 2020 (actual)
- First posted
- 9 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients undergoing screw osteosynthesis of radial head fractures at Universitätsspital Basel between June 2010 until June 2016
Key inclusion criteria (1 listed)
- screw osteosynthesis of radial head fractures
Key exclusion criteria (2 listed)
- unable to give consent
- dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| patient surveypatient survey on clinical outcome after screw osteosynthesis of radial head fractures | Other | – |
| analysis of radiographsanalysis of radiographs on radiological outcome after screw osteosynthesis of radial head fractures | Other | – |
Primary outcome
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)
4 secondary outcomes
elbow status assessed by Mayo Elbow Score (MEPS)
Time frame: 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
Patient reported outcome assessed by Quick Dash
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2020.
Related trials for Radial Head Fractures
Active, not recruiting
RHEVOLUTION Clinical Trial: Use of Two Radial Head Arthroplasty Designs for the Treatment of Elbow Instability
Elbow Arthropathy, Elbow Dislocation
Recruiting
The Utilization of Ultrasound to Diagnose Pediatric Elbow Fractures
Elbow Pain, Supracondylar Humerus Fracture
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Rikli, Prof. Dr. principal investigator
Department of Orthopaedics and Traumatology, University Hospital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radial Head Fractures, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in status of bone healing assessed by radiographs (time frame: 3 months and 9 months post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2020.