Treatment of Fifth Metatarsal Zone 3 Fractures

Study Overview
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Brief Summary
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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.

Official Title
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Treatment of Fifth Metatarsal Zone 3 Fractures - A Prospective, Randomized, Controlled Trial

Conditions
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Fractures, Stress, Metatarsal Fracture

Intervention / Treatment
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* Procedure: Operative
* Other: Walking boot orthosis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospecitve, randomized trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Operative<br>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<br>* Intramedullary screw fixation<br>* Other names: Osteosynthesis;Other: Walking boot orthosis<br>* 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.<br>|
| Active Comparator: Non-operative<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Palpatory pain | Visual Analog Scale below 3 | 2 years | 
| Radiological healing | Time to radiological callus formation | 2 years | 
| Work status | Time of sick leave | 2 years | 
| Refracture | Rate of refractures | 2 years | 
| Delayed union | Rate of delayed unions | 2 years | 
| Nonunions | Rate of nonunions | 2 years | 
| Level of activity | Time to normal activity level is resumed | 2 years |