Ireland
--:--IST
Latest
Clinical Trials in Norway / NCT04615650
Active, not recruiting Not applicable

RCT Comparing Non-operative vs Operative Treatment of Suprasyndesmotic Ankle Fractures.

NCT04615650 · tracked via the Priya Life Science Norway tracker
Phase
Not applicable
Started
2020-12-28
Last updated
2025-05-16

Condition(s) studied

Ankle Fractures

Investigational drug(s) / intervention(s)

Surgical treatmentAnkle orthosis

Surgical treatment: Surgical treatment of suprasyndesmotic ankle fractures

Ankle orthosis: Non-surgical treatment of suprasyndesmotic ankle fractures

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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 outcome measure(s)

Trial sites (4)

FacilityCityRegionStatus
Vestre Viken Hospital Trust Bærums verk Akershus
Østfold Hospital Trust Fredrikstad Akershus
Sykehuset Innlandet HF Gjøvik Innlandet
Oslo University Hospital Oslo Oslo

More Sykehuset Innlandet HF trials in Norway

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04615650 on ClinicalTrials.gov ↗ ← All trials in Norway