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Treatment of Fifth Metatarsal Zone 3 Fractures

Primary Purpose

Fractures, Stress, Metatarsal Fracture

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Operative
Walking boot orthosis
Sponsored by
Ostfold Hospital Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fractures, Stress

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Operative

    Non-operative

    Arm Description

    The patients in this arm will be treated operatively with intramedullar screw osteosynthesis. In addition to this, they will weight bear as tolareted in a walking boot orthosis for six weeks.

    The patients in this arm will have non-operative treatment with a walking boot orthosis for six weeks. They will weight bear as tolerated

    Outcomes

    Primary Outcome Measures

    Pain free weight bearing
    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 Outcome Measures

    Palpatory pain
    Visual Analog Scale below 3
    Radiological healing
    Time to radiological callus formation
    Work status
    Time of sick leave
    Refracture
    Rate of refractures
    Delayed union
    Rate of delayed unions
    Nonunions
    Rate of nonunions
    Level of activity
    Time to normal activity level is resumed

    Full Information

    First Posted
    April 9, 2021
    Last Updated
    April 14, 2021
    Sponsor
    Ostfold Hospital Trust
    Collaborators
    Oslo University Hospital, University Hospital, Akershus
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04847115
    Brief Title
    Treatment of Fifth Metatarsal Zone 3 Fractures
    Official Title
    Treatment of Fifth Metatarsal Zone 3 Fractures - A Prospective, Randomized, Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 10, 2021 (Anticipated)
    Primary Completion Date
    March 31, 2024 (Anticipated)
    Study Completion Date
    March 31, 2029 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Ostfold Hospital Trust
    Collaborators
    Oslo University Hospital, University Hospital, Akershus

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Fractures, Stress, Metatarsal Fracture

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Prospecitve, randomized trial
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Operative
    Arm Type
    Active Comparator
    Arm Description
    The patients in this arm will be treated operatively with intramedullar screw osteosynthesis. In addition to this, they will weight bear as tolareted in a walking boot orthosis for six weeks.
    Arm Title
    Non-operative
    Arm Type
    Active Comparator
    Arm Description
    The patients in this arm will have non-operative treatment with a walking boot orthosis for six weeks. They will weight bear as tolerated
    Intervention Type
    Procedure
    Intervention Name(s)
    Operative
    Other Intervention Name(s)
    Osteosynthesis
    Intervention Description
    Intramedullary screw fixation
    Intervention Type
    Other
    Intervention Name(s)
    Walking boot orthosis
    Intervention Description
    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 Outcome Measure Information:
    Title
    Pain free weight bearing
    Description
    Defined as Visual Analoge Scale below 3. The scale range is 0 to 10, where 0 means "no pain" and 10 means "worst pain".
    Time Frame
    2 years
    Secondary Outcome Measure Information:
    Title
    Palpatory pain
    Description
    Visual Analog Scale below 3
    Time Frame
    2 years
    Title
    Radiological healing
    Description
    Time to radiological callus formation
    Time Frame
    2 years
    Title
    Work status
    Description
    Time of sick leave
    Time Frame
    2 years
    Title
    Refracture
    Description
    Rate of refractures
    Time Frame
    2 years
    Title
    Delayed union
    Description
    Rate of delayed unions
    Time Frame
    2 years
    Title
    Nonunions
    Description
    Rate of nonunions
    Time Frame
    2 years
    Title
    Level of activity
    Description
    Time to normal activity level is resumed
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Marius Molund, PhD
    Phone
    0047 90093988
    Email
    marius.molund@so-hf.no
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Marius Molund, PhD
    Organizational Affiliation
    Ostfold HT
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Treatment of Fifth Metatarsal Zone 3 Fractures

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