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Mr Mark Foster


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Be Part of Research - Trial Details - SUBMIT study: metacarpal fracture fixation
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SUBMIT study: metacarpal fracture fixation

Not Recruiting

Open to: All Genders

Age: Adult

Birmingham

Medical Conditions

Topic: Surgery
Subtopic: Surgery
Disease: All Surgery

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Metacarpal fractures, commonly called broken fingers, account for about 40% of all hand injuries. Although generally surgery isn’t needed, when the break is particularly serious surgery may be required. In these cases, the broken sections of bone need to be surgically moved back into the correct place. They are then held in place by fixing a metal plate to the bone with screws, which stabilises the bone while it heals. Traditionally, the plate is held in place by fixing the screws above and below the fracture (bicortical fixation). Although this procedure is generally very reliable, the excess drilling could cause damage to the soft tissue of the hand. In this time of procedure it is very important that the screws are the correct size, as if they are not then this could also damage the surrounding soft tissue. Unicortical fixation is a new technique where the screw is only fixed to one side of the broken bone. This technique is much less complex than bicortical fixation, and so it could potentially cause less damage to the surrounding soft tissues in the hand. As only one hole is drilled, there are also less likely to be complications if the screw is not the right size. The aim of this study is to find out whether bicortical or unicortical fixation is better for patients in terms of recovery.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

01 Jun 2015 06 Apr 2018

Publications

2016 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/27538992 protocol

Participants are randomly allocated to one of two groups who will each have a different type of ORIF surgery. Those in the first group have the bicortical fixation procedure, in which the plate screws into both sides of the broken bone. Those in the second group have the unicortical fixation procedure, in which the plate screws only onto one side of the bone. At 6 weeks and 6 months, participants attend follow-up appointments in order to assess how well their fracture has healed.


Adults who have broken their fingers within 72 hours and are having plate fixation

You can take part if:



You may not be able to take part if:


1. Under 18 years of age2. Deemed not competent to sign the consent forms3. Pathologic fracture or a previous fracture of the same metacarpal4. Other injury to the same upper limb requiring surgery5. Major nerve injury (e.g., median, ulnar or radial)6. Multi-trauma or -fractured patient7. Revision procedure8. Pregnant patient9. Current or prior history of malignancy


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • University Hospital Birmingham NHS Foundation Trust
    Plastic Surgery Department Mindelson Way Edgbaston
    Birmingham
    B15 2WB

Not provided at time of registration

Mr Mark Foster



The study is sponsored by University Hospital Birmingham NHS Foundation Trust and funded by Royal Centre for Defence Medicine.



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What will you do next?
Read full details for Trial ID: ISRCTN18006607

Or CPMS 18642

Last updated 22 August 2016

This page is to help you find out about a research study and if you may be able to take part

You can print or share the study information with your GP/healthcare provider or contact the research team directly.   

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