Clinical trial NCT04615650: RCT Comparing Non-operative vs Operative Treatment of Suprasyndesmotic Ankle Fractures.
Official title: Non-operative Versus Operative Treatment of Suprasyndesmotic Ankle Fractures: A Prospective, Multicentre, Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Ankle Fractures
Keywords: ankle fractures
surgical treatment
conservative treatment
weight-bearing
Lead sponsor: Sykehuset Innlandet HF
Sponsor class: OTHER
Collaborators: name: Oslo University Hospital
name: Vestre Viken Hospital Trust
name: Ostfold Hospital Trust
First posted: 2020-11-04
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised controlled multicentre trial
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* patients who present with a closed, isolated fibular fracture classified as suprasyndesmotic (Weber C) with a medial clear space of less than 7 mm in mortise view on primary radiographs.
* presentation less than 14 days after the injury.

Exclusion Criteria:

* previous fractures or ligamentous injury to the injured ankle.
* pathological fracture.
* diabetic neuropathy or other neuropathies.
* drug abuse.
* inability to consent and/or comply.
* inability to understand Norwegian language.
* inability to walk unaided prior to the fracture.
* patients with a concomitant tibial fracture requiring surgical treatment are excluded, but patients with undisplaced concomitant tibial fractures can be included.
* patients from outside the catchment area of the recruiting hospitals. However, they can be included if they are willing to undergo follow-up visits at one of the recruiting hospitals.

Primary outcomes:
measure: Olerud-Molander Ankle Score (OMAS)
timeFrame: The main statistical analysis of the primary outcome will be based on the two-year follow-up.
Secondary outcomes:
measure: Ankle pain
timeFrame: The main statistical analysis of the outcome will be based on the two-year follow-up.
measure: Manchester-Oxford Foot Questionnaire (MOxFQ)
timeFrame: The main statistical analysis of the outcome will be based on the two-year follow-up.
measure: EuroQol questionnaire (EQ-5D)
timeFrame: The main statistical analysis of the outcome will be based on the two-year follow-up.
measure: Radiographic results
timeFrame: The main statistical analysis of the outcome will be based on the two-year follow-up.
measure: Range of motion
timeFrame: The main statistical analysis of the outcome will be based on the two-year follow-up.
measure: Adverse events
timeFrame: The main statistical analysis of the outcome will be based on the two-year follow-up.
Other outcomes:
Locations:
city: Gjøvik
country: Norway
facility: Sykehuset Innlandet HF
state: Innlandet
city: Bærums Verk
country: Norway
facility: Vestre Viken Hospital Trust
state: Viken
city: Fredrikstad
country: Norway
facility: Østfold Hospital Trust
state: Viken
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Sykehuset Innlandet HF
name: Håvard Furunes, PhD
role: PRINCIPAL_INVESTIGATOR
References: