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SUBMIT study: metacarpal fracture fixation

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN18006607
Enrollment
290
Registered
2015-11-19
Start date
2015-06-01
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Topic: Surgery

Interventions

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 (stan

Sponsors

University Hospital Birmingham NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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)

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Fracture union is assessed at 6 weeks and 6 months

Secondary

MeasureTime frame
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

Countries

United Kingdom

Contacts

Public ContactMark Foster

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026