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Completed

NCT Number: NCT04037540

Comparison of Conservative and Operative Treatment of Jones Fracture

The study deals with the topic of treatment of Jones fracture, comparing surgical and conservative approach. The fracture occurs especially in highly active individuals.

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Key information

Conditions

Fracture of Fifth Metatarsal Bone

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 70852, Czechia

About this study

The study deals with the topic of treatment of Jones fracture, comparing surgical and conservative approach. The fracture occurs especially in highly active individuals.

The study proposes a supposition of recommending the active operational approach, which shortens the period of healing by 6 weeks, limitation of physical activity by 4 weeks, and sick leave by 2 months. It also completely eliminates the need to perform a rigid fixation of the extremity for 8-12 weeks.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Jones fracture

Exclusion criteria

  • combined injury
  • recurring injury
  • diabetes mellitus
  • chronic renal insufficiency
  • osteopathy

Treatment and study plan

Operational approach

Procedure

Operational approach was used to treat the Jones fracture in patients randomized into the respective study arm.

Conservative approach

Procedure

Conservative approach was used to treat the Jones fracture in patients randomized into the respective study arm.

Primary outcomes

  1. The American Orthopaedic Foot & Ankle Society (AOFAS) score - 6 weeks

    Time frame: 6 weeks

    The improvement in The American Orthopaedic Foot & Ankle Society (AOFAS) score from the baseline was observed at 6 weeks after injury on a scale of 0-100.

  2. AOFAS score - 12 months

    Time frame: 12 months

    The improvement in The American Orthopaedic Foot & Ankle Society (AOFAS) score from the baseline was observed at 12 months after injury on a scale of 0-100.

Secondary outcomes

  1. Signs of healing on X-ray at 6 weeks

    Time frame: 6 weeks

    The presence or absence of signs of healing on X-ray were observed at 6 weeks after injury.

  2. Signs of healing on X-ray at 12 months

    Time frame: 6 weeks

    The presence or absence of signs of healing on X-ray were observed at 12 months after injury.

  3. Extremity loading

    Time frame: 6 weeks

    The ability to load the injured extremity was measured in per cent of full loading.

Sponsors and collaborators

Lead sponsor

University Hospital Ostrava

Other

Registry information

Important dates

Study start
2006
Primary completion
2011
Study completion
2018
First posted
Jul 30, 2019
Registry last updated
Jul 31, 2019

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.