About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Zone 3 fracture
Disqualifiers
Neuropathy
Open fractures
High energy injuries
Associated injury in the same or opposite extremity that may affect treatment or rehabilitation
Trial design
Parallel
Treatments tested in this trial
Operative
Procedure/SurgeryIntramedullary screw fixation
Walking boot orthosis
Other interventionNon-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.
Treatment groups
Trial outcomes
Primary outcomes
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 outcomes
Palpatory pain
Visual Analog Scale below 3
Radiological healing
Time to radiological callus formation
Work status
Time of sick leave
Refracture
Rate of refractures
Sponsors and contacts
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Ostfold Hospital Trust
Lead sponsor
Oslo University Hospital
Collaborator
University Hospital, Akershus
Collaborator