Lateral Malleolus Fractures
Conditions
Keywords
ER-stress-test negative, unimalleolar, fibula, Weber-B fractures
Brief summary
PRCT multicenter study to evaluate non-operative treatment protocols for treating ER-stress negative unimalleolar Weber-B type fibular fractures. Groups are: 1. 3 weeks in a removable splint 2. 3 weeks in a cast and 3. 6 weeks in a cast. Follow-up visits at 3, 6 and 12 weeks and after 1 and 2 years after injury. In each time X-rays laterally and mortise projections. Ankle functional outcome questionnaires: Olerud-Molander score, FAOS RAND-36 and VAS in follow up-visits 6 and 12 weeks and 1 and 2 year.
Detailed description
Prospective randomized controlled multicenter study to evaluate non-operative treatment protocols for treating ER-stress negative unimalleolar Weber-B type fibular fractures. Groups are: 1. 3 weeks in a removable splint 2. 3 weeks in a cast and 3. 6 weeks in a cast. Follow-up visits at 3, 6 and 12 weeks and after 1 and 2 years after injury. In each time X-rays laterally and mortise projections. Ankle functional outcome questionnaires: Olerud-Molander score, FAOS RAND-36 and VAS in follow up-visits 6 and 12 weeks and 1 and 2 year.
Interventions
OTHERSplint 3 weeks
A removable orthosis/splint. Dynacast/Ortho-Glass AS (BSN Medical). Splint is used for 3 weeks and no additional support is used after splint removal.
OTHERCast 3 weeks
A standard short boot cast from proximal tibia to MTP I-V joint line. Cast is made from 3M Scotchcast. Cast is removed after 3 weeks and no additional support is used after cast removal.
OTHERCast 6 weeks
standard short boot cast from proximal tibia to MTP I-V joint line. Cast is made from 3M Scotchcast. Cast is changed after 3 weeks and removed after 6 weeks. No additional support is used after cast removal.
Sponsors
Tampere University Hospital
University of Oulu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Stable Weber-B type fibula fracture * ER-stress negative * 16 or over years old * Willingness to participate on study proved by a signature and date * Walking without aid before accident * Treatment started within 7 days from injury
Exclusion criteria
* Prior ankle fracture or significant fracture in the area of ankle or leg * Bilateral ankle fracture * Pathological fracture * Diabetes mellitus or an other significant periferial neuropathy * municipality of Residence in some else catchment area than Oulu university hospital or Tampere university hospital * Patient's understanding or co-operation inadequate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Olerud-Molander score | 1 year | Ankle functional outcome measure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| FAOS | 1 year | Foot and Ankle Outcome Score |
| VAS | 1 year | Visual Analogue Scale pain and function |
| RAND 36 Health item survey | 1 year | Quality of life measurement |
| Fracture healing | 1 year | — |
Countries
Finland
Outcome results
None listed