SUBMIT study: metacarpal fracture fixation
| ISRCTN | ISRCTN18006607 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18006607 |
| Secondary identifying numbers | 18642 |
- Submission date
- 19/11/2015
- Registration date
- 19/11/2015
- Last edited
- 22/08/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
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
Contact information
Public
University Hospital Birmingham NHS Foundation Trust
Plastic Surgery Department
Mindelson Way
Edgbaston
B15 2WB
United Kingdom
Study information
| Study design | Randomised; Interventional; Design type: Not specified, Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Stability of unicortical vs bicortical metacarpal internal fixation trial (SUBMIT) |
| Study 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(s) | First Medical Research Ethics Committee, 19/11/2015, ref: 14/WM/1212 |
| 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 |
| Primary outcome measure | 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 study start date | 01/06/2015 |
| Overall study end date | 06/04/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 290; UK Sample Size: 290 |
| 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 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
- England
- United Kingdom
Study participating centre
Mindelson Way
Edgbaston
Birmingham
B15 2WB
United Kingdom
Sponsor information
Hospital/treatment centre
NIHR SRMRC, Research and Development
Queen Elizabeth Hospital
Edgbaston
Edgbaston
B15 2TH
England
United Kingdom
"ROR" |
https://ror.org/014ja3n03 |
|---|
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 18/08/2016 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
22/08/2016: Publication reference added.
