Treatment options for fifth metatarsal fractures
Official title: Treatment of Fifth Metatarsal Zone 3 Fractures - A Prospective, Randomized, Controlled Trial
Run by Ostfold Hospital Trust · NCT04847115 · Data updated 2026-11-12
This study tests whether using a special screw to fix fifth metatarsal fractures helps people walk without pain faster than just using a walking boot.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Ostfold Hospital Trust Academic / other |
| Locations | 3 sites (Grålum and 2 other locations) |
| Status | Recruiting |
| Started | April 10, 2021 |
| Main results expected | March 31, 2026 |
| Study ends | March 31, 2030 |
| Registry record updated | April 29, 2024 |
| Trial ID | NCT04847115 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are individuals diagnosed with Zone 3 fractures of the fifth metatarsal.
✕Probably not a fit
Patients with conditions such as neuropathy, open fractures, or those who have had their fracture for more than six months may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the effectiveness of osteosynthesis with intramedullary screw fixation compared to non-operative treatment using a walking boot for patients with Zone 3 fractures of the fifth metatarsal. The aim is to determine which approach allows for faster pain-free weight bearing. Current literature lacks robust evidence, primarily relying on retrospective studies, making this randomized controlled trial essential for strengthening the understanding of treatment options for these fractures.
Why it matters
Potential benefit: If successful, this study could provide clearer guidelines for treating fifth metatarsal fractures, potentially leading to improved recovery times for patients.
How similar studies have gone: While there has been limited research on this specific treatment comparison, previous studies have indicated varying outcomes for surgical versus non-surgical approaches, highlighting the need for this investigation.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Zone 3 fracture Exclusion Criteria: * Neuropathy * Open fractures * High energy injuries * Associated injury in the same or opposite extremity that may affect treatment or rehabilitation * Pressure ulcer(s) * Lack of consent competence * Fracture radiologically confirmed more than six months ago * No possibility of follow-up at one of the study centers * Established pseudarthrosis * Medical condition that contraindicates surgery * Non-compliance
Where it's running
-
Østfold Hospital Trust
Grålum, Norway Recruiting -
Akershus University Hospital
Lørenskog, Norway Recruiting -
Oslo University Hospital
Oslo, Norway Recruiting
Study contacts
- Principal investigator: Marius Molund, PhD — Ostfold HT
- Study coordinator: Marius Molund, PhD
- Email: marius.molund@so-hf.no
- Phone: 0047 90093988
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.