Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT04847115

Treatment of Fifth Metatarsal Zone 3 Fractures

Led by Ostfold Hospital Trust · Updated on 2024-04-29

100

Participants Needed

3

Research Sites

468 weeks

Total Duration

On this page

Sponsors

O

Ostfold Hospital Trust

Lead Sponsor

O

Oslo University Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

The fifth metatarsal is one of the bones where stress fractures can occur. Current literature provides support for both operative and non-operative treatment, but is mostly based on retrospective studies. One small randomized controlled trial reported faster recovery in the surgery group, but this study is probably subject to selection bias as well as underpowered design. There is a need to strengthen the knowledge base regarding treatment of stress fractures in the fifth metatarsal. This study seeks to answer whether osteosynthesis with an intramedullar screw fixation gives faster painfree weight bearing compared to non-operative treatment with a walking boot.

CONDITIONS

Official Title

Treatment of Fifth Metatarsal Zone 3 Fractures

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Zone 3 fracture
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 3 locations

1

Østfold Hospital Trust

Grålum, Norway

Actively Recruiting

2

Akershus University Hospital

Lørenskog, Norway

Actively Recruiting

3

Oslo University Hospital

Oslo, Norway

Actively Recruiting

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Research Team

M

Marius Molund, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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