Comparison of Conservative and Operative Treatment of Jones Fracture

July 30, 2019 updated by: University Hospital Ostrava
The study deals with the topic of treatment of Jones fracture, comparing surgical and conservative approach. The fracture occurs especially in highly active individuals.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
    • Moravian-Silesian Region
      • Ostrava, Moravian-Silesian Region, Czechia, 70852
        • University Hospital Ostrava

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

- Jones fracture

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Operational approach
The patients enrolled in this arm underwent surgical treatment of the Jones fracture.
Procedure: Operational approach
Operational approach was used to treat the Jones fracture in patients randomized into the respective study arm.
Experimental: Conservative approach
The patients enrolled in this arm were treated conservatively, using fixation of the injured extremity.
Procedure: Conservative approach
Conservative approach was used to treat the Jones fracture in patients randomized into the respective study arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 weeks
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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 weeks
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.
6 weeks
Extremity loading
Time Frame: 6 weeks
The ability to load the injured extremity was measured in per cent of full loading.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Ostrava

Investigators

  • Principal Investigator: Jiří Demel, MD, University Hospital Ostrava
  • Study Director: Leopold Pleva, Ass.Prof.,MD,CSc., University Hospital Ostrava

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2006

Primary Completion (Actual)

December 31, 2011

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

July 26, 2019

First Submitted That Met QC Criteria

July 26, 2019

First Posted (Actual)

July 30, 2019

Study Record Updates

Last Update Posted (Actual)

July 31, 2019

Last Update Submitted That Met QC Criteria

July 30, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FNO-KUCH-01-Jones
  • CZ.02.1.01/00/00/17_049/00084 (Other Grant/Funding Number: Ministry of Education of the Czech Republic)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

The researchers do not plan to share individual participant data with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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