Use of Weightbearing Radiographs to Determine Treatment of bi- and Trimalleolar Ankle Fractures
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorOstfold Hospital Trust
About this trial
The aim of this study is to evaluate the outcomes after non-operative treatment of weightbearing stable bi-and trimalleolar ankle fractures.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
-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
Disqualifiers
- 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)
Trial design
Design model
Single group
Treatments tested in this trial
Non-operative treatment
Other interventionPatients will be treated with a walker-orthosis for 6 weeks. Weightbearing as tolerated
Treatment groups
29 Participants
are divided into 1 treatment groupGroup A: Non-operative treatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Olerud Molander Score (OMAS) to measure a change over time
Condition specific, patient reported measure of ankle-fracture symptoms
Time frame
6 week, 12 weeks, 1year, 2 yearsSecondary outcomes
1
Manchester-Oxford Foot Questionnaire (MOxFQ)
Patients reported outcomes
Time frame
6 week, 12 weeks, 1year, 2 years2
Range of Motion measured by a goniometer (ad modum Lindsjo)
dorsiflexion and plantarflexion
Time frame
6 week, 12 weeks, 1year, 2 years3
Numeric Rating Scale (NRS)
Ankle pain in rest, at night and in daily activities, a 11-point numeric scale ranging from 0-10
Time frame
6 week, 12 weeks, 1year, 2 years4
Euroqol questionnaire (EQ- 5D)
Health related quality of life
Time frame
6 week, 12 weeks, 1year, 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov