Ankle Fracture, Bimalleolar, Ankle Fracture, Trimalleolar
Conditions
Brief summary
The aim of this study is to evaluate the outcomes after non-operative treatment of weightbearing stable bi-and trimalleolar ankle fractures.
Interventions
Patients will be treated with a walker-orthosis for 6 weeks. Weightbearing as tolerated
Sponsors
Ostfold Hospital Trust
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* -With bi- and trimalleolar ankle fractures with less than 7 mm medial clear space on non-weightbearing radiographs that are deemed stable by weightbearing radiographs. * With type B medial malleolus fractures between the tip and the plafond and type C medial malleolus fractures at the level of the plafond (Herscovici classification). (6) * With fractures in the distal 1/3 of fibula (not-Maisonneuve) * Enabling stability evaluation within 14 days after injury * 18-75 years of age * with pre-injury walking ability without aids
Exclusion criteria
* \- With primary unstable ankle fractures, \> 7mm medial clear space on primary radiographs * With fracture reduction prior to initial radiographic evaluation, open fracture, fractures resulting from high-energy trauma or multi trauma and pathological fracture * With type A medial malleolus avulsion fractures \< 5mm (at the tip of the malleolus), that are not suitable for surgical intervention. * With Herscovici type D fractures, involving Lauge-Hansen SA2 fractures (supracollicular fracture - vertical, oblique or transverse direction of the plafond) * With displaced posterior malleolus fractures that needs fixation in the judgement of the attending surgeon * With neuropathies and symptomatic joint diseases such as Rheumatoid Arthritis * That are assumed not compliant (such as drug abuse, cognitive- and/or psychiatric disorders) * With previous history ipsilateral ankle fracture * With previous history ipsilateral major ankle-/foot surgery * Who live outside the hospital catchment areas not available to follow up * With insufficient Norwegian or English language skills * Non-compliant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Olerud Molander Score (OMAS) to measure a change over time | 6 week, 12 weeks, 1year, 2 years | Condition specific, patient reported measure of ankle-fracture symptoms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Range of Motion measured by a goniometer (ad modum Lindsjo) | 6 week, 12 weeks, 1year, 2 years | dorsiflexion and plantarflexion |
| Numeric Rating Scale (NRS) | 6 week, 12 weeks, 1year, 2 years | Ankle pain in rest, at night and in daily activities, a 11-point numeric scale ranging from 0-10 |
| Manchester-Oxford Foot Questionnaire (MOxFQ) | 6 week, 12 weeks, 1year, 2 years | Patients reported outcomes |
| Registrations of complications/adverse events | 0-2 years | Registration of loss of congruence, delayed union, non-union, thromboembolic events |
| Posttraumatic osteoarthritis (OA) | 2 years and 5 years | CT-scan (Kellgren-Lawrence classification) |
| Euroqol questionnaire (EQ- 5D) | 6 week, 12 weeks, 1year, 2 years | Health related quality of life |
Countries
Norway
Contacts
Primary ContactMarius Molund, PhD
Backup ContactSilje Karlsen
Outcome results
None listed