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Treatment of Fifth Metatarsal Zone 3 Fractures

Sponsor
Ostfold Hospital Trust (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04847115
Collaborator
Oslo University Hospital (Other), University Hospital, Akershus (Other)
100
Enrollment
2
Arms
95.7
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Operative
  • Other: Walking boot orthosis
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Prospecitve, randomized trialProspecitve, randomized trial
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Treatment of Fifth Metatarsal Zone 3 Fractures - A Prospective, Randomized, Controlled Trial
Anticipated Study Start Date :
Apr 10, 2021
Anticipated Primary Completion Date :
Mar 31, 2024
Anticipated Study Completion Date :
Mar 31, 2029

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Operative

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.

Procedure: Operative
Intramedullary screw fixation
Other Names:
  • Osteosynthesis

    • Other: Walking boot orthosis
    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.
    Active Comparator: Non-operative

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

    Other: Walking boot orthosis
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Pain free weight bearing [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 Outcome Measures

    1. Palpatory pain [2 years]

      Visual Analog Scale below 3

    2. Radiological healing [2 years]

      Time to radiological callus formation

    3. Work status [2 years]

      Time of sick leave

    4. Refracture [2 years]

      Rate of refractures

    5. Delayed union [2 years]

      Rate of delayed unions

    6. Nonunions [2 years]

      Rate of nonunions

    7. Level of activity [2 years]

      Time to normal activity level is resumed

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Ostfold Hospital Trust
    • Oslo University Hospital
    • University Hospital, Akershus

    Investigators

    • Principal Investigator: Marius Molund, PhD, Ostfold HT

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ostfold Hospital Trust
    ClinicalTrials.gov Identifier:
    NCT04847115
    Other Study ID Numbers:
    • 201144
    First Posted:
    Apr 19, 2021
    Last Update Posted:
    Apr 19, 2021
    Last Verified:
    Apr 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Fractures, Bone
    Fractures, Stress

    Study Results

    No Results Posted as of Apr 19, 2021