Condition category
Musculoskeletal Diseases
Date applied
19/11/2015
Date assigned
19/11/2015
Last edited
22/08/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
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.

Who can participate?
Adults who have broken their fingers within 72 hours and are having plate fixation

What does the study involve?
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.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
University Hospitals Birmingham NHS Foundation Trust (UK)

When is the study starting and how long is it expected to run for?
June 2015 to April 2018

Who is funding the study?
Royal Centre for Defence Medicine (UK)

Who is the main contact?
Mr Mark Foster

Trial website

Contact information

Type

Public

Primary contact

Mr Mark Foster

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

18642

Study information

Scientific title

Stability of unicortical vs bicortical metacarpal internal fixation trial (SUBMIT)

Acronym

SUBMIT

Study hypothesis

The aim of this trial is to compare the functional outcomes and complications of patients having unicortical versus bicortical fixation for diaphyseal metacarpal fractures.

Ethics approval

First Medical Research Ethics Committee, 19/11/2015, ref: 14/WM/1212

Study design

Randomised; Interventional; Design type: Not specified, Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Surgery; Subtopic: Surgery; Disease: All Surgery

Intervention

Participants are randomly allocated to one of two groups, who will receive a different type of open reduction internal fixation (ORIF) surgery.

Group 1: Participants undergo bicortical fixation (standard practice), in which both the dorsal and palmar cortices of the metacarpal are drilled though
Group 2: Participants undergo unicortical fixation, in which only the near cortex is drilled

Participants in both groups are followed up for 6 months to monitor recovery.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Fracture union is assessed at 6 weeks and 6 months

Secondary outcome measures

1. Complication rate is monitored continually throughout study
2. Fluroscopy exposure is measured during surgery
3. Implant failure is measured at 6 weeks and 6 months
4. Post operative stiffness is measured at 6 weeks and 6 months
5. Surgical time is measured during surgery

Overall trial start date

01/06/2015

Overall trial end date

06/04/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 or over
2. Metacarpal diaphyseal fractures that require plate fixation
3. Patients undergoing anaesthesia with axillary brachial plexus regional blocks
4. Acute injury (within 72 hours)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 290; UK Sample Size: 290

Participant exclusion criteria

1. Under 18 years of age
2. Deemed not competent to sign the consent forms
3. Pathologic fracture or a previous fracture of the same metacarpal
4. Other injury to the same upper limb requiring surgery
5. Major nerve injury (e.g., median, ulnar or radial)
6. Multi-trauma or -fractured patient
7. Revision procedure
8. Pregnant patient
9. Current or prior history of malignancy

Recruitment start date

01/06/2015

Recruitment end date

06/04/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

University Hospital Birmingham NHS Foundation Trust

Sponsor details

NIHR SRMRC
Research and Development
Queen Elizabeth Hospital
Edgbaston
Edgbaston
B15 2TH
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Royal Centre for Defence Medicine

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

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

Publication citations

Additional files

Editorial Notes

22/08/2016: Publication reference added.