Fractures, Stress, Metatarsal Fracture
Conditions
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.
Interventions
PROCEDUREOperative
Intramedullary screw fixation
OTHERWalking 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.
Sponsors
Oslo University Hospital
University Hospital, Akershus
Ostfold Hospital Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospecitve, randomized trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Radiological healing | 2 years | Time to radiological callus formation |
| Work status | 2 years | Time of sick leave |
| Refracture | 2 years | Rate of refractures |
| Palpatory pain | 2 years | Visual Analog Scale below 3 |
| Nonunions | 2 years | Rate of nonunions |
| Level of activity | 2 years | Time to normal activity level is resumed |
| Delayed union | 2 years | Rate of delayed unions |
Countries
Norway
Contacts
Primary ContactMarius Molund, PhD
Outcome results
None listed