Weight-bearing radiographs will be used to evaluate the stability of suprasyndesmotic ankle fractures. Patients with stable fractures will be randomised to operative or non-operative treatment.
Suprasyndesmotic fractures (Weber type C) are historically treated operatively because of the assumption that the distal tibiofibular syndesmosis is ruptured, leading to joint instability (Lauge-Hansen 1950, Boden 1989). However, the medial deltoid ligament may function as the main stabiliser of the ankle joint by preventing external rotation of the talus and therefore maintains the dynamic congruity (Michelson 2007). Due to the stabilising effect of the deltoid ligament, an increasing number of transsyndesmotic fractures (Weber type B) are treated non-operatively with excellent results and without the burden of complications that accompany surgery (Gougoulias 2017, Mittal 2017, Bauer 1985). The aims of the present study are to test the stability of suprasyndesmotic ankle fractures on weight-bearing radiographs and to evaluate the effect of non-operative versus operative treatment of stable suprasyndesmotic fractures. The patients will have a weight-bearing (at least 50% of body weight) standing radiograph for the evaluation of the stability of the fracture. Patients with a congruent ankle mortise (i.e., stable fracture) on weight-bearing radiographs will be randomised to either operative (ORIF, reference treatment) or non-operative treatment (cast). Patients in both groups are allowed full weight-bearing. Patients with an incongruent ankle mortise (i.e., unstable fracture) will be treated operatively according to current clinical practice and included in a parallel observational cohort study. Patients who are unwilling to participate in the intervention study are also invited to participate in the observational cohort study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
120
Surgical treatment of suprasyndesmotic ankle fractures
Non-surgical treatment of suprasyndesmotic ankle fractures
Vestre Viken Hospital Trust
Bærums verk, Akershus, Norway
Østfold Hospital Trust
Fredrikstad, Akershus, Norway
Sykehuset Innlandet HF
Gjøvik, Innlandet, Norway
Oslo University Hospital
Oslo, Oslo, Norway
Olerud-Molander Ankle Score (OMAS)
The primary outcome measure is the Olerud-Molander Ankle Score (OMAS), which is a condition-specific, patient-reported measure of ankle-fracture symptoms. OMAS ranges from 0 to 100, with higher scores indicating better outcomes and fewer symptoms.
Time frame: The main statistical analysis of the primary outcome will be based on the two-year follow-up.
Ankle pain
Ankle pain is measured by the Numeric Rating Scale (NRS), which is an 11-point numeric scale ranging from 0 ("no pain") to 10 ("worst pain imaginable").
Time frame: The main statistical analysis of the outcome will be based on the two-year follow-up.
Manchester-Oxford Foot Questionnaire (MOxFQ)
Ankle-related symptoms are, in addition to the OMAS questionnaire, measured by the Manchester-Oxford Foot Questionnaire (MOxFQ). The MOxFQ is a 16-item questionnaire consisting of three subscales: walking/standing (w/s) problems (seven items), pain (p) (five items), and issues related to social interaction (si) (four items). Patients score each question on a five-point Likert scale ranging from 0 to 4, with 4 representing the worst stage. Raw scores are converted to a numeric scale ranging from 0 to 100, with 100 denoting the most severe symptoms.
Time frame: The main statistical analysis of the outcome will be based on the two-year follow-up.
EuroQol questionnaire (EQ-5D)
Quality of life is measured by the EuroQol questionnaire (EQ-5D). EQ-5D is a validated generic health-related quality-of-life instrument. It consists of two parts: EQ-5D descriptive part and EQ-5D visual analogue scale. The descriptive part in-cludes five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxie-ty/depression), each with three possible answers ("no problems", "some problems", and "major problems"). EQ-5D VAS is a visual analogue scale of self-related overall health, ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).
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Time frame: The main statistical analysis of the outcome will be based on the two-year follow-up.
Radiographic results
Radiographic results (fracture healing, joint congruency, syndesmotic reduction and post-traumatic arthritis) is assessed by plain radiographs and computed tomography (CT). Post-traumatic arthritis is graded on radiographs according to van Dijk et.al.
Time frame: The main statistical analysis of the outcome will be based on the two-year follow-up.
Range of motion
Range of motion of both ankles will be assessed by a physiotherapist or surgeon (who are not directly involved in the study) using a goniometer to measure active loaded dorsiflexion.
Time frame: The main statistical analysis of the outcome will be based on the two-year follow-up.
Adverse events
Adverse events, including deep vein thrombosis, nerve injury, wound infection and other complications occurring during the 24 months of follow-up are registered. Reoperations and crossover from non-operative to operative treatment are also registered.
Time frame: The main statistical analysis of the outcome will be based on the two-year follow-up.