Wrist FractureNCT03126474
Defining Displacement Thresholds for Surgical Intervention for Distal Radius Fractures - a Delphi Study
An observational study of Wrist Fracture and Distal Radius Fracture, run by University of Leicester at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Wrist Fracture, Distal Radius Fracture
- How many people
- 43 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Feb 2017to 28 Jun 2017
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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: 1. - experienced hand and wrist surgeons who are members of the British Society for Surgery of the Hand. 2. - trauma surgeons who deal with these injuries and operate on them regularly. 3. - 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.
Who may be able to join
- Experienced expert surgeons who regularly treat patients with distal radius fractures and/or have researched the subject extensively
Who cannot join
- Excluded if not an experienced specialist surgeon
Trial locations and contacts
1 site in 1 country.
About this 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.
Read the 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
- Conditions
- Wrist Fracture, Distal Radius Fracture
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement on questions from expert panel
Agreement is defined as a consensus of 70% between expert panel members
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2017
- Study start17 Feb 2017
- Primary completion28 May 2017
- Study completion28 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wrist FractureStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Other
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nick A Johnson, MBCHB, Principal investigator, University of Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03126474
- Sponsor's protocol ID
- 0593
- Status last verified
- Apr 2017
- First submitted
- 19 Apr 2017
- Last updated
- 30 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining Displacement Thresholds for Surgical Intervention for Distal Radius Fractures - a Delphi Study
- ClinicalTrials.gov ID
- NCT03126474
- Acronym / sponsor ID
- 0593
- Conditions
- Wrist Fracture, Distal Radius Fracture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Study start
- 17 Feb 2017 (actual)
- Primary completion
- 28 May 2017 (actual)
- Study completion
- 28 Jun 2017 (actual)
- First posted
- 24 Apr 2017 (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.
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.
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 design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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: 1. - experienced hand and wrist surgeons who are members of the British Society for Surgery of the Hand. 2. - trauma surgeons who deal with these injuries and operate on them regularly. 3. - 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.
Key inclusion criteria (1 listed)
- Experienced expert surgeons who regularly treat patients with distal radius fractures and/or have researched the subject extensively
Key exclusion criteria (1 listed)
- Excluded if not an experienced specialist surgeon
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Agreement on questions from expert panel
Time frame: 10 weeks
Agreement is defined as a consensus of 70% between expert panel members
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 30 Jan 2020.
- Individual participant dataSharing planned: No
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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.
Nick A Johnson, MBCHB principal investigator
University of Leicester
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 Wrist Fracture and Distal Radius Fracture, run by University of Leicester at 1 site in United Kingdom.
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 1 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 30 Jan 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 United Kingdom. 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?
Agreement on questions from expert panel (time frame: 10 weeks). 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 30 Jan 2020.