- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03126474
Defining Displacement Thresholds for Surgical Intervention for Distal Radius Fractures - a Delphi Study
Wrist (distal radius fractures) are very common injuries. Despite this there is still much controversy about the best way to treat them and in particular which ones require intervention. Many studies have been carried out but there is no strong evidence to answer these questions. The investigators are carrying out a Delphi study which involves seeking consensus from experts at treating these injuries about the best way to manage them. UK and international expert surgeons will take part in three rounds of online questionnaires to help decide how much displacement of the fracture will trigger treatment for different common wrist fracture cases. The aim of the study is to obtain expert opinion through consensus from the expert group about the amount of displacement that is acceptable until intervention is required.
This will provide guidance and reduce variation between treating surgeons.
Study Overview
Status
Conditions
Detailed Description
The investigators conducted a systematic review following SIGN guidelines with the British Society for Surgery of the Hand(BSSH) blue book committee looking at the relationship between measured radiological parameters and functional outcome. 42 studies were identified all of which were of low quality. The conclusion was; 'Currently there is insufficient evidence to demonstrate an association between any measured radiological parameters and patient rated outcome. Further high quality research is required to answer this question.' The review identified that the most commonly measured parameters were radial height, radial inclination, volar tilt and intra articular step and gap.
The Delphi process involves seeking consensus from renowned experts to provide an answer to specific research questions. Through this Delphi study the investigators intend to investigate and achieve consensus regarding the threshold for intervention in displaced distal radius fractures. The aim is to quantify how much displacement can be accepted before intervention is required for different patient groups. This can then help guide surgeons with their management decisions and help reduce variation.
A three round modified Delphi process will be used. Identified experts will be sent an invitation email with an attached electronic form which they will be asked to fill in and return to indicate if they wish to take part.
Invitation emails will be sent on the same day to all experts and they will be given 14 days to return the acceptance form.
The first round will start 14 days after the invitation email is sent. The first round electronic survey link will simultaneously be emailed to all participants who have agreed to take part. After seven days, a second e-mail (reminder) will be sent to the participants who do not respond to the first invitation. On the 15th day, responses for the first round will be collected. The investigators will analyse the collected responses and the level of agreement in the responses will be assessed.
The second round will be conducted 14 days after the first round is finalised and analysed. Only the responders who take part in the first round will be invited. The participants will be given the information about the results of the first round ,the methodology used and a review of the literature. Reminder e-mails will be sent on the 7th day, concluding the second round at 15th day. The second round results will be evaluated using the same method as that for the first round. The format of the third round (if required due to persistent disagreement) will be similar to that of the second round. Consensus is defined as 70% agreement between participants
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Leicester, United Kingdom
- Nick Johnson
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Experienced expert surgeons who regularly treat patients with distal radius fractures and/or have researched the subject extensively will be invited to take part. All participants will be aged over 18 years.
The investigators defined experts in 3 ways:
- - experienced hand and wrist surgeons who are members of the British Society for Surgery of the Hand.
- - trauma surgeons who deal with these injuries and operate on them regularly.
- - surgeons who are also researchers who have published studies investigating outcome in patients with distal radius fractures in the last 5 years so have a comprehensive understanding of the nature of the injury and likely outcome.
Description
Inclusion Criteria:
- Experienced expert surgeons who regularly treat patients with distal radius fractures and/or have researched the subject extensively
Exclusion Criteria:
- Excluded if not an experienced specialist surgeon
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Delphi panel
Group of expert surgeons who have experience dealing with distal radius fractures No intervention will be performed on a patient.
Participants will discuss and aim to obtain agreement about best treatment options for a variety of cases
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Agreement on questions from expert panel
Time Frame: 10 weeks
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Agreement is defined as a consensus of 70% between expert panel members
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10 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nick A Johnson, MBCHB, University of Leicester
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0593
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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