Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04847115

Treatment of Fifth Metatarsal Zone 3 Fractures

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Fractures, Stress Fractures, Bone Metatarsal Fracture Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Østfold Hospital Trust, Grålum, Norway

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Operative

Procedure

Intramedullary screw fixation

Other names: Osteosynthesis

Walking boot orthosis

Other

Non-operative treatment with walking boot orthosis for six weeks. The non-operative study arm will use walking boot orthosis only. The operative study arm will use walking boot orthosis as adjuvant treatment.

Primary outcomes

  1. Pain free weight bearing

    Time frame: 2 years

    Defined as Visual Analoge Scale below 3. The scale range is 0 to 10, where 0 means "no pain" and 10 means "worst pain".

Secondary outcomes

  1. Palpatory pain

    Time frame: 2 years

    Visual Analog Scale below 3

  2. Radiological healing

    Time frame: 2 years

    Time to radiological callus formation

  3. Work status

    Time frame: 2 years

    Time of sick leave

  4. Refracture

    Time frame: 2 years

    Rate of refractures

  5. Delayed union

    Time frame: 2 years

    Rate of delayed unions

  6. Nonunions

    Time frame: 2 years

    Rate of nonunions

  7. Level of activity

    Time frame: 2 years

    Time to normal activity level is resumed

Study contacts

Contact information is provided by the study sponsor or research team.

Marius Molund, PhD

CONTACT

[email protected]

0047 90093988

Sponsors and collaborators

Lead sponsor

Ostfold Hospital Trust

Other

Collaborators

  • Oslo University Hospital
  • University Hospital, Akershus

Registry information

Official study title

Treatment of Fifth Metatarsal Zone 3 Fractures - A Prospective, Randomized, Controlled Trial

Important dates

Study start
2021
Primary completion
2026
Study completion
2030
First posted
Apr 19, 2021
Registry last updated
Apr 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.