Use of Weightbearing Radiographs to Determine Treatment of bi- and Trimalleolar Ankle Fractures

Ostfold Hospital Trust1 site in 1 country29 target enrollmentFebruary 28, 2023

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Ankle Fracture, Bimalleolar
Sponsor: Ostfold Hospital Trust
Enrollment: 29
Locations: 1
Primary Endpoint: Olerud Molander Score (OMAS) to measure a change over time
Status: Recruiting
Last Updated: 2 years ago

The aim of this study is to evaluate the outcomes after non-operative treatment of weightbearing stable bi-and trimalleolar ankle fractures.

Registry

clinicaltrials.gov

Start Date

February 28, 2023

End Date

December 31, 2032

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Sponsor

Ostfold Hospital Trust

Responsible Party

Sponsor

•-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

•- 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

Olerud Molander Score (OMAS) to measure a change over time

Time Frame: 6 week, 12 weeks, 1year, 2 years

Condition specific, patient reported measure of ankle-fracture symptoms

Posttraumatic osteoarthritis (OA)(2 years and 5 years)
Manchester-Oxford Foot Questionnaire (MOxFQ)(6 week, 12 weeks, 1year, 2 years)
Range of Motion measured by a goniometer (ad modum Lindsjo)(6 week, 12 weeks, 1year, 2 years)
Euroqol questionnaire (EQ- 5D)(6 week, 12 weeks, 1year, 2 years)
Registrations of complications/adverse events(0-2 years)
Numeric Rating Scale (NRS)(6 week, 12 weeks, 1year, 2 years)