Clinical trial Recruiting at 3 sites Interventional Ages 18 to 65

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 typeInterventional
Ages18 Years to 65 Years
SexAll
Enrollment100 (estimated)
SponsorOstfold Hospital Trust
Academic / other
Locations3 sites (Grålum and 2 other locations)
StatusRecruiting
StartedApril 10, 2021
Main results expectedMarch 31, 2026
Study endsMarch 31, 2030
Registry record updatedApril 29, 2024
Trial IDNCT04847115 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.