Treatment options for fifth metatarsal fractures
Treatment of Fifth Metatarsal Zone 3 Fractures - A Prospective, Randomized, Controlled Trial
NA · Ostfold Hospital Trust · NCT04847115
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Ostfold Hospital Trust (other) |
| Locations | 3 sites (Grålum and 2 other locations) |
| Trial ID | NCT04847115 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with Zone 3 fractures of the fifth metatarsal.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Grålum and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Fractures, Stress, Metatarsal Fracture