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Comparison of Conservative and Operative Treatment of Jones Fracture

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04037540
Recruitment Status : Completed
First Posted : July 30, 2019
Last Update Posted : July 31, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital Ostrava

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

Condition or disease Intervention/treatment Phase
Fracture of Fifth Metatarsal Bone Procedure: Operational approach Procedure: Conservative approach Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The patients with Jones fracture were randomized into one of the two study groups - operational or conservative approach.
Masking: None (Open Label)
Masking Description: No masking was used in the study
Primary Purpose: Treatment
Official Title: Comparison of Conservative and Operative Treatment of Jones Fracture
Actual Study Start Date : January 1, 2006
Actual Primary Completion Date : December 31, 2011
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- Jones fracture

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04037540


Locations
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Czechia
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, Czechia, 70852
Sponsors and Collaborators
University Hospital Ostrava
Investigators
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Principal Investigator: Jiří Demel, MD University Hospital Ostrava
Study Director: Leopold Pleva, Ass.Prof.,MD,CSc. University Hospital Ostrava

Publications:

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Responsible Party: University Hospital Ostrava
ClinicalTrials.gov Identifier: NCT04037540    
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 )
First Posted: July 30, 2019    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The researchers do not plan to share individual participant data with other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital Ostrava:
Jones fracture
The American Orthopaedic Foot & Ankle Society (AOFAS)
Herbert screw
Additional relevant MeSH terms:
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Fractures, Bone
Wounds and Injuries