UnknownNot Applicable

Fifth Metatarsal Orthopedic Outcome Trial

Netherlands64 participantsStarted 2022-09-01

Plain-language summary

Fractures of the shaft, distal to zone three, of the fifth metatarsal often occur after foot distortion. There is very little evidence available regarding the optimal treatment. Currently the most common treatment is prolonged cast immobilization. Operative treatment has been reported as an alternative and could promote early recovery. No comparative study has been published regarding optimal treatment

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 18 years or older at the time of study entry * Informed consent * Competent to participate in follow up and fill out questionnaires * Dislocated (1mm or more on plain radiography) fracture of the shaft, distal from zone 3, of the fifth metatarsal according to the Orthopedic Trauma Association (OTA) classification 87.5.3 A-C Exclusion Criteria: * Open fracture * Proximal fifth metatarsal fracture, Jones fracture * Clinically significant or symptomatic vascular or neurologic pathology on the ipsilateral leg * Former surgery or history of development disorder of the contralateral fifth metatarsal * Multiple fractured metatarsals in the affected foot * Medical history of Rheumatoid Arthritis * Unable to undergo surgical procedure

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Numerical rating scale-11 score for pain 3 months

Timeframe: 3 months after intervention

Trial details

NCT IDNCT05450107

SponsorIsala

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-06

Contact for this trial

Maarten Cornelissen, MD

0886248117 m.p.cornelissen@isala.nl

View on ClinicalTrials.gov More Metatarsal Fracture trials