Treatment of Fifth Metatarsal Zone 3 Fractures
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Operative, Walking boot orthosis.
- Who it may be relevant to
- Registry conditions: Fractures, Stress, Metatarsal Fracture. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Norway
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Treatment of Fifth Metatarsal Zone 3 Fractures - A Prospective, Randomized, Controlled Trial
Overview
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.
Interventions
- Procedure Operative
Intramedullary screw fixation - 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.
Primary outcome measures
- Pain free weight bearing [Time frame: 2 years]
Secondary outcome measures (7)
- Palpatory pain [Time frame: 2 years]
- Radiological healing [Time frame: 2 years]
- Work status [Time frame: 2 years]
- Refracture [Time frame: 2 years]
- Delayed union [Time frame: 2 years]
- Nonunions [Time frame: 2 years]
- Level of activity [Time frame: 2 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Norway · 3 centers
- Østfold Hospital Trust — Grålum
- Akershus University Hospital — Lørenskog
- Oslo University Hospital — Oslo
Identifiers
NCT: NCT04847115 · 201144